WorldWideScience

Sample records for astatine radiopharmaceuticals prospects

  1. Complexation study on no-carrier-added astatine with insulin: A candidate radiopharmaceutical

    Energy Technology Data Exchange (ETDEWEB)

    Lahiri, Susanta [Chemical Sciences Division, Saha Institute of Nuclear Physics, 1/AF Bidhannagar, Kolkata 700 064 (India)], E-mail: susanta.lahiri@saha.ac.in; Roy, Kamalika [Chemical Sciences Division, Saha Institute of Nuclear Physics, 1/AF Bidhannagar, Kolkata 700 064 (India); Sen, Souvik [Berhampur Sadar Hospital, Berhampur, Murshidabad 742 101 (India)

    2008-12-15

    No-carrier-added astatine radionuclides produced in the {sup 7}Li-irradiated lead matrix were separated from bulk lead nitrate target by complexing At with insulin, followed by dialysis. The method offers simultaneous separation of At from lead as well as its complexation with insulin. The At-insulin complex might be a potential radiopharmaceutical in the treatment of hepatocellular carcinoma. The stability of At-insulin complex was checked by dialysis against deionized water and Ringer lactate (RL) solution. It has been found that the half-life of At-insulin complex is about {approx}12 h, when dialyzed against deionized water and is only 6 h, when dialyzed against RL solution having the same composition as blood serum. The 6 h half-life of this Insulin-At complex is perfect for killing cancer cells from external cell surfaces as the half-life of internalization of insulin molecule inside the cell is 7-12 h.

  2. Complexation study on no-carrier-added astatine with insulin: A candidate radiopharmaceutical

    International Nuclear Information System (INIS)

    Lahiri, Susanta; Roy, Kamalika; Sen, Souvik

    2008-01-01

    No-carrier-added astatine radionuclides produced in the 7 Li-irradiated lead matrix were separated from bulk lead nitrate target by complexing At with insulin, followed by dialysis. The method offers simultaneous separation of At from lead as well as its complexation with insulin. The At-insulin complex might be a potential radiopharmaceutical in the treatment of hepatocellular carcinoma. The stability of At-insulin complex was checked by dialysis against deionized water and Ringer lactate (RL) solution. It has been found that the half-life of At-insulin complex is about ∼12 h, when dialyzed against deionized water and is only 6 h, when dialyzed against RL solution having the same composition as blood serum. The 6 h half-life of this Insulin-At complex is perfect for killing cancer cells from external cell surfaces as the half-life of internalization of insulin molecule inside the cell is 7-12 h

  3. 211At-Rh(16-S4-diol) complex as a precursor for astatine radiopharmaceuticals

    International Nuclear Information System (INIS)

    Pruszynski, M.; Bilewicz, A.

    2006-01-01

    211 At is one of the most promising radionuclides in α-radioimmunotherapy (α-RIT). Unfortunately, biomolecules labeled by direct electrophilic astatination are unstable due to the rapid loss of 211 At under both in vitro and in vivo conditions. The present paper describes the results of our studies on attaching At - to the rhodium(III) complex with thioether ligand: 1,5,9,13-etrathiacyclohexadecane-3,11-diol (16-S4-diol). Rh 3+ was chosen as a moderately soft metal cation which should form very strong bonds with soft At - anions, but first of all because of the kinetic inertness of low spin rhodium(III) d 6 complexes. The 16-S4-diol ligand was selected due to formation of stable complexes with Rh 3+ . The experiments related to optimization of the reaction conditions were performed with the 131 I, basing on a chemical similarity of I - to At - . The experiments with 211 At were then carried out under the conditions found optimal for I - . The preliminary results are promising, and indicate a possibility for astatination of biomolecules by using the 211 At-Rh(16-S4-diol) complex

  4. Radiopharmaceuticals in China. Current status and prospects

    Energy Technology Data Exchange (ETDEWEB)

    Jia, Hong-Mei; Liu, Bo-Li [Beijing Normal Univ. (China). Key Laboratory of Radiopharmaceuticals

    2014-04-01

    The review provides an overview of the current status of radiopharmaceuticals in China for in vivo clinical use and also describes some important advances in the past three decades. Development of the diagnostic and therapeutic radiopharmaceuticals as well as basic research on radiopharmaceutical chemistry are being introduced. The radiotracers developed in China include: (1) Brain perfusion imaging agents and CNS radiotracers for β-amyloid plaques, σ{sub 1} receptors, and dopamine D{sub 2} or D{sub 4} receptors; (2) {sup 99m}Tc- and {sup 18}F-labeled myocardial perfusion imaging agents; (3) tumor imaging agents including integrin-targeting radiotracer, novel sentinel lymph node imaging agents, hypoxia imaging agents, {sup 99m}Tc-labeled glucose derivatives, σ{sub 2} receptor imaging agents, folate receptor imaging agents, and potential radiotracers for imaging of human telomerase reverse transcriptase expression; (4) Potential infection imaging agents; (5) Potential asialoglycoprotein receptor imaging agents; (6) Other imaging agents. Moreover, some prospects of research and development of radiopharmaceuticals in the near future are discussed. (orig.)

  5. The current situation and future prospects of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Ando, Atsushi

    2001-01-01

    Radiopharmaceuticals play an important role in nuclear medicine. In this paper, nuclear medicine relating to radiopharmaceuticals was briefly described. And I would like to focus on the current situation and future prospects of radiopharmaceuticals. Nuclear medicine in this century should take the following directions. Firstly, cancer treatment by radionuclides will be one of the promising fields in oncology. Secondly, in order to achieve evidence-based medicine, sensitive, quantitative imaging using the nuclides will be necessary in nuclear medicine. Under these circumstances, it is important to develop radiopharmaceuticals for sensitive, quantitative imaging and therapeutic radiopharmaceuticals. (author)

  6. Radiochemistry of astatine

    International Nuclear Information System (INIS)

    Ruth, T.J.; Dombsky, M.; D'Auria, J.M.; Ward, T.E.

    1988-01-01

    This monograph is a review of the literature through 1987 and covers the methods of producing the radioisotopes of astatine and the inorganic, nuclear, and organic chemistry of astatine. The discussion is limited to chemical and physical chemical properties of astatine. The monograph, after the introduction, is divided into chapters titled: production methods, nuclear spectroscopy, chemistry of astatine, separation and isolation (dry and wet), and selected procedures. 209 refs., 15 figs., 7 tabs

  7. Present status and prospect of copper radiopharmaceuticals

    International Nuclear Information System (INIS)

    Chen Huawei; Li Hongfeng; Liu Boli

    1996-01-01

    In the past decade most of the efforts of copper radiopharmaceuticals research has been focused on bis(thiosemicarbazonato) copper complexes for use in myocardial and brain imaging agents. In the present work, the analogs of bis(thiosemicarbazone) is studied in labeling antibodies and tumors. The retention mechanism of Cu-PTSM is investigated. Other kinds of ligands, BAT (N 2 S 2 ) for example, can be used to prepare neutral copper complexes in order to obtain brain radiopharmaceuticals in future. (60 refs.)

  8. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Theobald, A.E.

    1989-01-01

    This book is a review of the latest developments in radiopharmaceuticals. It covers the development of radiopharmaceutical compounds, the theory and practice of their synthesis, and examples of their application. Also covers safe handling of radiopharmaceuticals, legislation affecting their use, radiation monitoring, radiochromatography, and computer techniques

  9. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    1981-01-01

    The catalogue offers a wide-spread product range which meets the requirements of the international trend of in vivo application of radiopharmaceuticals. It includes: (1) conditions of sale and delivery, (2) delivery schedule for radiopharmaceuticals, (3) technical information, (4) product specifications, and (5) the complete delivery programme

  10. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1988-01-01

    Different forms of radiopharmaceuticals such as radioactive gases, aerosols and colloids used for diagnostic techniques and radiotherapy and methods of labelling them are discussed. Some reference is made to their documentation, handling and quality control. (U.K.)

  11. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Ganatra, R.D.

    1992-01-01

    Today there are an estimated ten million nuclear imaging procedures, performed each year, in just the United States, and the number is still growing. More than 30,000 therapy procedures are performed in the USA each year using radiopharmaceuticals. Moreover, while the numbers continue to grow, so also do the variety of the procedures being employed. A weakness of nuclear medicine is related also to one of its strengths. Unlike other types of imaging where only an instrument and the patient are required (e.g., with ultrasonics); nuclear medicine requires a radiopharmaceutical. At the same time, the variety of radiopharmaceuticals offers the ability to trace one or more particular functions of the human body. This provides nuclear medicine with great variety in detecting specific pathologies. Various nuclear medicine studies are possible because of the localization of radiopharmaceuticals in different organs

  12. Radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Hunt, F C; Wilson, J G

    1980-03-13

    The claim describes a reducing metal complex of a compound in a suitable form for labelling with technetium-99m for radiopharmaceutical purposes, the compound being a complex derived from an indene heterocycle structure. The indene heterocycle structure is selected from the group consisting of iminodiacetic acid derivates of benzimidazole, benzthiazole and benzoxazole.

  13. Formation and decomposition of astatine molecules

    International Nuclear Information System (INIS)

    Takahashi, Naruto; Ishikuro, Mituhiro; Baba Hiroshi

    1989-01-01

    A method determining the boiling points of elementary astatine and astatine iodide has been developed (K. Otozai and N. Takahashi, Radio. Chim. Acta 31, (1982) 201). Further, it was concluded from the simple rule among the boiling point of elementary halogens and interhalogen compounds that elementary astatine might exist in diatomic molecules as the other halogens. In the present work the reaction mechanisms of elementary astatine with radioactive iodine and organic solvents were studied by means of radiogaschromatography in order to obtain further experimental evidences for diatomic astaine molecules. The following conclusions were obtained by the analysis of reaction kinetics. Two astatine atoms are lost from the elementary astatine fraction per each radioactive decay of astatine. The astatine radical or hot atom liberated by the decay of the complementary astatine atom immediately reacts with iodine or organic solvents. Thus formed astatine compounds decompose in turn due to the decay of astatine

  14. Organic astatine compounds, their preparation and properties

    Energy Technology Data Exchange (ETDEWEB)

    Vasaros, L; Berei, K

    1985-01-01

    Aromatic astatine compounds of possible medical application were prepared by high energy substitutions, by astatine-halogen, and by electrophil astatine-hydrogen substitutions at the Joint Institute of Nuclear Researches, Dubna. Physico-chemical properties of organic astatine compounds such as boiling point and evaporation heat, and the refraction and dissociation energy of carbon-astatine bonds were determined experimentally by gas chromatography. The results are compared with extrapolated data. (V.N.). 41 refs.; 7 figs.; 5 tables.

  15. Automated astatination of biomolecules - a stepping stone towards multicenter clinical trials

    DEFF Research Database (Denmark)

    Aneheim, Emma; Albertsson, Per; Bäck, Tom

    2015-01-01

    To facilitate multicentre clinical studies on targeted alpha therapy, it is necessary to develop an automated, on-site procedure for conjugating rare, short-lived, alpha-emitting radionuclides to biomolecules. Astatine-211 is one of the few alpha-emitting nuclides with appropriate chemical...... vector, which can guide the radiation to the cancer cells. Consequently, an appropriate method is required for coupling the nuclide to the vector. To increase the availability of astatine-211 radiopharmaceuticals for targeted alpha therapy, their production should be automated. Here, we present a method...... challenging, alpha-emitting radionuclide. In this work, we describe the process platform, and we demonstrate the production of both astaine-211, for preclinical use, and astatine-211 labelled antibodies....

  16. Bibliography of astatine chemistry and biomedical applications

    International Nuclear Information System (INIS)

    Berei, K.; Vasaros, L.

    1992-02-01

    An overall bibliography is presented on astatine chemistry and on the biomedical applications of its 211 At isotope. The references were grouped in the following chapters: General reviews; Discovery, Natural Occurence; Nuclear Data; Preparation, Handling, Radiation Risk; Physico-chemical Properties; Astatine Compounds and Chemical Reactions; Biological Effects and Applications. Entries are sorted alphabetically by authors name in each chapter, and cross-references to other chapters are provided if appropriate. (R.P.)

  17. VII. Boettstein Colloquium: PET-Radiopharmaceuticals at PSI: achievement and future prospects

    International Nuclear Information System (INIS)

    Schubiger, P.A.; Beer, H.F.; Blaeuenstein, P.; Leenders, K.E.

    1993-01-01

    The three sessions of the 1993 Boettstein colloquium dealt with the following topics: - PET-radiopharmaceuticals, - PET-scanning: significance of tracer uptake, - clinical options using PET. 22 papers were presented. figs., refs

  18. VII. Boettstein Colloquium: PET-Radiopharmaceuticals at PSI: achievement and future prospects

    Energy Technology Data Exchange (ETDEWEB)

    Schubiger, P A; Beer, H F; Blaeuenstein, P; Leenders, K E

    1994-12-31

    The three sessions of the 1993 Boettstein colloquium dealt with the following topics: - PET-radiopharmaceuticals, - PET-scanning: significance of tracer uptake, - clinical options using PET. 22 papers were presented. figs., refs.

  19. VII. Boettstein Colloquium: PET-Radiopharmaceuticals at PSI: achievement and future prospects

    Energy Technology Data Exchange (ETDEWEB)

    Schubiger, P.A.; Beer, H.F.; Blaeuenstein, P.; Leenders, K.E.

    1993-12-31

    The three sessions of the 1993 Boettstein colloquium dealt with the following topics: - PET-radiopharmaceuticals, - PET-scanning: significance of tracer uptake, - clinical options using PET. 22 papers were presented. figs., refs.

  20. Recent advances in the organic chemistry of astatine

    International Nuclear Information System (INIS)

    Berei, K.; Vasaros, L.

    1994-03-01

    Investigation on the chemical behaviour of astatine in the last decade are surveyed. The survey covers the physical and chemical properties of astatine, synthesis and identification of organic astatine compounds, their physicochemical properties. A special chapter is devoted to biomedical applications, including inorganic 211 At species, 211 At-labelled proteins and drugs. An extensive bibliography of the related literature is given. (N.T.) 129 refs.; 12 figs.; 14 tabs

  1. Hospitable radiopharmaceuticals

    International Nuclear Information System (INIS)

    Gonzalez, M.B.

    1994-01-01

    Two types of hospitalary radiopharmaceutical was given in Nuclear Medicine: the centralized and hospitalary radiopharmaceuticals. The good practice in the use, instrumentation and quality control of radiopharmaceuticals are used in nuclear medicine for diagnostic and therapy diseases

  2. Click synthesis of PET radiopharmaceuticals

    International Nuclear Information System (INIS)

    Xu Mei; Kuang Chunxiang

    2009-01-01

    Increasing attention has been focused on synthesis radiopharmaceuticals for positron emission tomography (PET). The recent years witnessed applications of click chemistry to PET radiopharmaceutical synthesis,because of its distinctive advantages including high speed,yield and stereospecificity under mild conditions. Synthesis of 18 F-labeled and 11 C-labeled radiopharmaceuticals and intermediates via click chemistry are reviewed. The future trend of click chemistry for the synthesis of PET radiopharmaceutical is prospected. (authors)

  3. Lung radiopharmaceuticals

    International Nuclear Information System (INIS)

    Gonzalez, B.M.

    1994-01-01

    Indication or main clinical use of Lung radiopharmaceuticals is presented and clasification of radiopharmaceuticals as ventilation and perfusion studies. Perfusion radiopharmaceuticals, main controls for administration quality acceptance. Clearence after blood administration and main clinical applications. Ventilation radiopharmaceuticals, gases and aerosols, characteristics of a ideal radioaerosol, techniques of good inhalation procedure, clinical applications. Comparison of several radiopharmaceuticals reflering to retention time as 50% administered dose, percent administered dose at 6 hours post inhalation, blood activity at 30 and 60 minutes post inhalation, initial lung absorbed dose, cumulated activity.Kinetic description of two radiopharmaceuticals, 99mTcDTPA and 99mTc-PYP

  4. Radiopharmaceuticals generalities

    International Nuclear Information System (INIS)

    Leon Cabana, A.S.

    1994-01-01

    Many applications in nuclear medicine used as diagnostic techniques, images methods with direct and indirect labelled compounds in organs. A brief description about scintillator counters or gamma counters SPECT(single photon emission computed tomography) and PECT (positron emission computed tomography), as well as therapeutic proceedings,radiopharmaceutical classification, labell steps,administration form in the body,physical form and the best radiopharmaceutical ideal classification. Two tables was used contain radiopharmaceuticals more used in diagnostic and more used in therapic uses. Tabs

  5. Experimental and computational evidence of halogen bonds involving astatine

    Science.gov (United States)

    Guo, Ning; Maurice, Rémi; Teze, David; Graton, Jérôme; Champion, Julie; Montavon, Gilles; Galland, Nicolas

    2018-03-01

    The importance of halogen bonds—highly directional interactions between an electron-deficient σ-hole moiety in a halogenated compound and an acceptor such as a Lewis base—is being increasingly recognized in a wide variety of fields from biomedicinal chemistry to materials science. The heaviest halogens are known to form stronger halogen bonds, implying that if this trend continues down the periodic table, astatine should exhibit the highest halogen-bond donating ability. This may be mitigated, however, by the relativistic effects undergone by heavy elements, as illustrated by the metallic character of astatine. Here, the occurrence of halogen-bonding interactions involving astatine is experimentally evidenced. The complexation constants of astatine monoiodide with a series of organic ligands in cyclohexane solution were derived from distribution coefficient measurements and supported by relativistic quantum mechanical calculations. Taken together, the results show that astatine indeed behaves as a halogen-bond donor—a stronger one than iodine—owing to its much more electrophilic σ-hole.

  6. Radiopharmaceutical development

    International Nuclear Information System (INIS)

    Zielinski, F.W.; Robinson, G.D. Jr.; MacDonald, N.S.

    1976-01-01

    Progress is reported in the following areas of research: compact cyclotron production of 123 I iodide for radiopharmaceutical synthesis; synthesis of 123 I-labeled compounds for myocardial imaging and evaluation of kidney and liver functions; 62 Cu: a short-lived, generator-produced, positron emitting radionuclide for radiopharmaceuticals; dry radioaerosols for lung airway imaging; and improved particulate agents for perfusion imaging

  7. Radiopharmaceutical licensing

    International Nuclear Information System (INIS)

    Mather, S.J.

    1992-01-01

    Recent health service legislation, and especially the loss of crown immunity has once again focussed attention on the arrangements for licensing of radiopharmaceuticals. The aim of the article is to describe in general terms the UK licensing system and in particular to provide guidance to those responsible for the supply of radiopharmaceuticals in hospitals. (author)

  8. New radiopharmaceuticals

    International Nuclear Information System (INIS)

    Payoux, P.; Esquerre, J.P.; Alonso, M.; Tafani, M.

    2008-01-01

    With the development of positron emission tomography, the significant increase in prescriptions of [ 18 F]F.D.G. has underlined the interest for molecular imaging in many pathologies. Facing the demand of 'new' radiopharmaceuticals (frequently clinically validated in the last century) for more and more specific diagnosis, the nuclear physician is confronted with a sparse offer of the radiopharmaceutical companies and a particularly complicated radiopharmaceutical legislation. This paper briefly reports on the radiopharmaceutical statutes encountered in France nowadays; it emphasizes that is essential to deeply modify the conditions to obtain a marketing authorization for radiopharmaceuticals if we want to propose to our patients the kind of right they have to expect from nuclear medicine. (authors)

  9. The reaction of astatine with aromatic diazonium compounds

    International Nuclear Information System (INIS)

    Visser, G.W.M.; Diemer, E.L.

    1982-01-01

    Astatine reacts prefrentially with that type of aromatic diazonium salt that decomposes via a radical reaction channel (homolytic breakage of the C-N bond). The dediazonation with p-aminobenzoic acid and p-toluidine as model compounds was investigated through estatin produced in the 209 Bi(α,2n) 211 At reaction. (author)

  10. 6. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Schiller, P.; Havranek, E.; Majer, J.

    1981-01-01

    Radionuclides commonly used in medicine are surveyed and their nuclear characteristics are presented. The methods are given of their preparation, most frequent use and detection. The list is given of radiopharmaceuticals included in the Czechoslovak Pharmacopoeia CsL 3 , ie., sodium chromate( 51 Cr), sodium iodide( 131 I), hippuran( 131 I), sodium phosphate( 32 P), colloidal gold( 198 Au), rose bengal sodium salt( 131 I), and sodium pertechnetate(sup(99m)Tc) injections. Characteristics, chemical preparation, identification tests, packaging, storage, application and dosage are shown for each preparation. Also listed are important unofficial radiopharmaceuticals, their main characteristics and data on their preparation and application. (B.S.)

  11. Measurement of the first ionization potential of astatine by laser ionization spectroscopy

    Science.gov (United States)

    Rothe, S.; Andreyev, A. N.; Antalic, S.; Borschevsky, A.; Capponi, L.; Cocolios, T. E.; De Witte, H.; Eliav, E.; Fedorov, D. V.; Fedosseev, V. N.; Fink, D. A.; Fritzsche, S.; Ghys, L.; Huyse, M.; Imai, N.; Kaldor, U.; Kudryavtsev, Yuri; Köster, U.; Lane, J. F. W.; Lassen, J.; Liberati, V.; Lynch, K. M.; Marsh, B. A.; Nishio, K.; Pauwels, D.; Pershina, V.; Popescu, L.; Procter, T. J.; Radulov, D.; Raeder, S.; Rajabali, M. M.; Rapisarda, E.; Rossel, R. E.; Sandhu, K.; Seliverstov, M. D.; Sjödin, A. M.; Van den Bergh, P.; Van Duppen, P.; Venhart, M.; Wakabayashi, Y.; Wendt, K. D. A.

    2013-01-01

    The radioactive element astatine exists only in trace amounts in nature. Its properties can therefore only be explored by study of the minute quantities of artificially produced isotopes or by performing theoretical calculations. One of the most important properties influencing the chemical behaviour is the energy required to remove one electron from the valence shell, referred to as the ionization potential. Here we use laser spectroscopy to probe the optical spectrum of astatine near the ionization threshold. The observed series of Rydberg states enabled the first determination of the ionization potential of the astatine atom, 9.31751(8) eV. New ab initio calculations are performed to support the experimental result. The measured value serves as a benchmark for quantum chemistry calculations of the properties of astatine as well as for the theoretical prediction of the ionization potential of superheavy element 117, the heaviest homologue of astatine. PMID:23673620

  12. Lung radiopharmaceuticals; Radioformacos pulmonares

    Energy Technology Data Exchange (ETDEWEB)

    Gonzalez, B M [Instituto Nacional de Pediatroa (Mexico)

    1994-12-31

    Indication or main clinical use of Lung radiopharmaceuticals is presented and clasification of radiopharmaceuticals as ventilation and perfusion studies. Perfusion radiopharmaceuticals, main controls for administration quality acceptance. Clearence after blood administration and main clinical applications. Ventilation radiopharmaceuticals, gases and aerosols, characteristics of a ideal radioaerosol, techniques of good inhalation procedure, clinical applications. Comparison of several radiopharmaceuticals reflering to retention time as 50% administered dose, percent administered dose at 6 hours post inhalation, blood activity at 30 and 60 minutes post inhalation, initial lung absorbed dose, cumulated activity.Kinetic description of two radiopharmaceuticals, 99mTcDTPA and 99mTc-PYP.

  13. Astatine-211 Radiochemistry: The Development Of Methodologies For High Activity Level Radiosynthesis

    International Nuclear Information System (INIS)

    Zalutsky, Michael R.

    2012-01-01

    Targeted radionuclide therapy is emerging as a viable approach for cancer treatment because of its potential for delivering curative doses of radiation to malignant cell populations while sparing normal tissues. Alpha particles such as those emitted by 211At are particularly attractive for this purpose because of their short path length in tissue and high energy, making them highly effective in killing cancer cells. The current impact of targeted radiotherapy in the clinical domain remains limited despite the fact that in many cases, potentially useful molecular targets and labeled compounds have already been identified. Unfortunately, putting these concepts into practice has been impeded by limitations in radiochemistry methodologies. A critical problem is that the synthesis of therapeutic radiopharmaceuticals provides additional challenges in comparison to diagnostic reagents because of the need to perform radio-synthesis at high levels of radioactivity. This is particularly important for α-particle emitters such as 211At because they deposit large amounts of energy in a highly focal manner. The overall objective of this project is to develop convenient and reproducible radiochemical methodologies for the radiohalogenation of molecules with the α-particle emitter 211At at the radioactivity levels needed for clinical studies. Our goal is to address two problems in astatine radiochemistry: First, a well known characteristic of 211At chemistry is that yields for electrophilic astatination reactions decline as the time interval after radionuclide isolation from the cyclotron target increases. This is a critical problem that must be addressed if cyclotrons are to be able to efficiently supply 211At to remote users. And second, when the preparation of high levels of 211At-labeled compounds is attempted, the radiochemical yields can be considerably lower than those encountered at tracer dose. For these reasons, clinical evaluation of promising 211At-labeled targeted

  14. ASTATINE-211 RADIOCHEMISTRY: THE DEVELOPMENT OF METHODOLOGIES FOR HIGH ACTIVITY LEVEL RADIOSYNTHESIS

    Energy Technology Data Exchange (ETDEWEB)

    MICHAEL R. ZALUTSKY

    2012-08-08

    Targeted radionuclide therapy is emerging as a viable approach for cancer treatment because of its potential for delivering curative doses of radiation to malignant cell populations while sparing normal tissues. Alpha particles such as those emitted by 211At are particularly attractive for this purpose because of their short path length in tissue and high energy, making them highly effective in killing cancer cells. The current impact of targeted radiotherapy in the clinical domain remains limited despite the fact that in many cases, potentially useful molecular targets and labeled compounds have already been identified. Unfortunately, putting these concepts into practice has been impeded by limitations in radiochemistry methodologies. A critical problem is that the synthesis of therapeutic radiopharmaceuticals provides additional challenges in comparison to diagnostic reagents because of the need to perform radio-synthesis at high levels of radioactivity. This is particularly important for {alpha}-particle emitters such as 211At because they deposit large amounts of energy in a highly focal manner. The overall objective of this project is to develop convenient and reproducible radiochemical methodologies for the radiohalogenation of molecules with the {alpha}-particle emitter 211At at the radioactivity levels needed for clinical studies. Our goal is to address two problems in astatine radiochemistry: First, a well known characteristic of 211At chemistry is that yields for electrophilic astatination reactions decline as the time interval after radionuclide isolation from the cyclotron target increases. This is a critical problem that must be addressed if cyclotrons are to be able to efficiently supply 211At to remote users. And second, when the preparation of high levels of 211At-labeled compounds is attempted, the radiochemical yields can be considerably lower than those encountered at tracer dose. For these reasons, clinical evaluation of promising 211At

  15. Synthesis and Evaluation of Astatinated N-[2-(Maleimido)ethyl]-3-(trimethylstannyl)benzamide Immunoconjugates

    DEFF Research Database (Denmark)

    Aneheim, Emma; Gustafsson, Anna; Albertsson, Per

    2016-01-01

    Effective treatment of metastasis is a great challenge in the treatment of different types of cancers. Targeted alpha therapy utilizes the short tissue range (50-100 μm) of α particles, making the method suitable for treatment of disseminated occult cancers in the form of microtumors or even single...... to the antibody arbitrarily on lysine residues. By instead coupling astatine to disulfide bridges in the antibody structure, the immunoreactivity of the antibody conjugates could possibly be increased. Here, the disulfide-based conjugation was performed using a new coupling reagent, maleimidoethyl 3......-(trimethylstannyl)benzamide (MSB), and evaluated for chemical stability in vitro. The immunoconjugates were subsequently astatinated, resulting in both high radiochemical yield and high specific activity. The MSB-conjugate was shown to be stable with a long shelf life prior to the astatination. In a comparison...

  16. Radiopharmaceuticals for bone scintillators

    International Nuclear Information System (INIS)

    Rey, A.M.

    1994-01-01

    One of the diagnostic techniques used in nuclear medicine is the bone scintiscanning with labelled compounds for obtain skeletal images. The main sections in this work are: (1) bone composition and anatomy;(2)skeletal radiopharmaceutical development;(3)physical properties of radionuclides;(4)biological behaviour and chemical structures;(5)radiopharmaceuticals production for skeletal scintillation;(6)kits;(7)dosimetry and toxicity.tabs

  17. Radiopharmaceuticals for nuclear cardiology

    International Nuclear Information System (INIS)

    Leon Cabana, Alba

    1994-01-01

    One of the diagnostic technique periodically used in Nuclear Medicine is the angiographic studi e, employee for detect cardiovascular diseases. The radiopharmaceutical more used in the angiographic ones is 99mTc. Between thetopics described in the present work it find: myocardial infarction, radiopharmaceuticals classification for cardiac studies, labelled proceedings, cardiovascular diseases

  18. Radiopharmaceuticals for therapy

    International Nuclear Information System (INIS)

    Lazarus, C.R.; Maisey, M.N.

    1985-01-01

    Several factors influencing the choice of radiopharmaceutical used in the treatment of benign and malignant disease are discussed. A brief review is given of the routine clinical uses of radiopharmaceuticals including treatments for hyperthyroidism, thyroid cancer, polycythaemia rubra vera and intracavitary therapy. Finally clinical situations using radionuclides under evaluation including the treatment of bone disease, adrenal tumours and monoclonal antibodies are discussed. (UK)

  19. Some aspects of the organic, biological and inorganic chemistry of astatine

    International Nuclear Information System (INIS)

    Visser, G.W.M.

    1982-01-01

    Astatine has no stable isotopes and the radioactive isotopes with half-lives sufficiently long for chemical experiments ( 209 At, 210 At, 211 At) must be produced artificially with a cyclotron or with a high energy accelerator by spallation of Th. This thesis deals with the synthesis and chemistry of At-compounds and the determination of some of their properties. (C.F.)

  20. 18F-Labelled catecholamine type radiopharmaceuticals in the diagnosis of neurodegenerative diseases and neuroendocrine tumours: approaches to synthesis and development prospects

    Science.gov (United States)

    Vatsadze, S. Z.; Eremina, O. E.; Veselova, I. A.; Kalmykov, S. N.; Nenajdenko, V. G.

    2018-04-01

    The pathogenesis of many socially significant diseases such as neurodegenerative dementias and neuroendocrine tumours involves imbalance of neurotransmitters. Among the known neuroimaging methods, positron emission tomography (PET) is the most perfect and informative technique for diagnosing these diseases. The potential of PET is largely determined by the inventory of available radiopharmaceuticals, that is, biologically active molecules containing short-lived nuclides with positron decay. This review gives a systematic account of the application of fluorine-18-labelled catecholamine type radiopharmaceuticals in clinical investigations of the sympathetic and central nervous systems. The methods for the synthesis of these agents and existing problems are considered. The material is arranged according to the mechanisms of reactions that underlie the synthetic approaches: electrophilic, nucleophilic and metal-catalyzed reactions. The bibliography includes 198 references.

  1. Radiopharmaceuticals for neurotransmitter imaging

    Energy Technology Data Exchange (ETDEWEB)

    Oh, Seung Jun [Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of)

    2007-04-15

    Neurotransmitter imaging with radiopharmaceuticals plays major role for understanding of neurological and psychiatric disorders such as Parkinson's disease and depression. Radiopharmaceuticals for neurotransmitter imaging can be divided to dopamine transporter imaging radiopharmaceuticals and serotonin transporter imaging radiopharmaceuticals. Many kinds of new dopamine transporter imaging radiopharmaceuticals has a tropane ring and they showed different biological properties according to the substituted functional group on tropane ring. After the first clinical trials with [{sup 123}I] {beta} -CIT, alkyl chain substituent introduced to tropane ring amine to decrease time for imaging acquisition and to increase selectivity. From these results, [{sup 123}I]PE2I, [18F]FE-CNT, [{sup 123}I]FP-CIT and [{sup 18}F]FP-CIT were developed and they showed high uptake on the dopamine transporter rich regions and fast peak uptake equilibrium time within 4 hours after injection. [{sup 11}C]McN 5652 was developed for serotonin transporter imaging but this compound showed slow kinetics and high background radioactivity. To overcome these problems, new diarylsulfide backbone derivatives such as ADAM, ODAM, AFM, and DASB were developed. In these candidates, [{sup 11}C]AFM and [{sup 11}C]DASB showed high binding affinity to serotonin transporter and fast in vivo kinetics. This paper gives an overview of current status on dopamine and serotonin transporter imaging radiopharmaceuticals and the development of new lead compounds as potential radiopharmaceuticals by medicinal chemistry.

  2. The development of cyclotron radiopharmaceuticals

    International Nuclear Information System (INIS)

    Yang, Seung Dae; Chun, K. W.; Suh, Y. S.; Lee, J. D.; Ahn, S. H. and others

    1999-03-01

    The purpose of this project is to develop the radiopharmaceuticals and automatic synthetic unit for labelled compounds, and to establish mass production system of radiopharmaceuticals. These will contribute to the early diagnosis of the disease hard to cure. The contents of this project are as follows, the development of the radiopharmaceutical for imaging of cancer, the development of automatic synthesizer for the synthesis of radio-pharmaceuticals, the development of hormone derivatives labelled with 12 '3I, the development of the radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for imaging of myocardial metabolism

  3. Radiopharmaceutical scanning agents

    International Nuclear Information System (INIS)

    1976-01-01

    This invention is directed to dispersions useful in preparing radiopharmaceutical scanning agents, to technetium labelled dispersions, to methods for preparing such dispersions and to their use as scanning agents

  4. Radiopharmaceuticals 1994. Nil desperandum

    International Nuclear Information System (INIS)

    Cox, P.H.; Meyer, G.J.

    1995-01-01

    On the basis of the discussions at a symposium held in Duesseldorf and attended by representatives of various interested bodies, European legislation as it affects radiopharmaceuticals is reviewed. Due consideration is given to the new, centralised and decentralised, registration procedures, effective since 1 January 1995. The dossier required to support an application for marketing authorisation is discussed, separate consideration being given to single-photon emitters, therapeutic radio-nuclides and positron-emitting radiopharmaceuticals. The role of the European Pharmacopoiea is also considered. It is concluded that the new, modified procedures for the registration of medicinal products in the European Union may actually inhibit free availability of radiopharmaceuticals within the Community, and that there is a strong case for modification of the European Directives so that radiopharmaceuticals are placed in a separate category to therapeutic drugs, with less stringent registration requirements. (orig.)

  5. Radiopharmaceutical drug review process

    International Nuclear Information System (INIS)

    Frankel, R.

    1985-01-01

    To ensure proper radioactive drug use (such as quality, diagnostic improvement, and minimal radioactive exposure), the Food and Drug Administration evaluates new drugs with respect to safety, effectiveness, and accuracy and adequacy of the labeling. The IND or NDA process is used for this purpose. A brief description of the process, including the Chemical Classification System and the therapeutic potential classification, is presented as it applies to radiopharmaceuticals. Also, the status of the IND or NDA review of radiopharmaceuticals is given

  6. Preparation of radiopharmaceutical formulations

    International Nuclear Information System (INIS)

    Simon, J.; Garlich, J.R.; Frank, R.K.; McMillan, K.

    1998-01-01

    Radiopharmaceutical formulations for complexes comprising at least one radionuclide complexed with a ligand, or its physiologically-acceptable salts thereof, especially 153 samarium-ethylenediaminetetramethylenephosphonic acid, which optionally contains a divalent metal ion, e.g. calcium, and is frozen, thawed, and then administered by injection. Alternatively, the radiopharmaceutical formulations must contain the divalent metal and are frozen only if the time before administration is sufficiently long to cause concern for radiolysis of the ligand. 2 figs., 9 tabs

  7. Radiopharmaceuticals for cerebral studies

    International Nuclear Information System (INIS)

    Leon Cabana, Alba

    1994-01-01

    For obtain good brain scintillation images in nuclear medicine must be used several radiopharmaceuticals. Cerebral studies give a tumors visual image as well as brain anomalities detection and are helpful in the diagnostic diseases . Are described in this work: a cerebrum radiopharmaceuticals classification,labelled compounds proceeding and Tc 99m good properties in for your fast caption, post administration and blood purification for renal way

  8. Regulatory aspects of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1985-01-01

    Regulatory systems in the field of radiopharmaceuticals have two main purposes: efficacy and safety. Efficacy expresses the quality of the diagnostic and therapeutic process for the patient. Safety involves the patient, the staff, and the environment. The world situation regarding regulations for radiopharmaceuticals is reviewed on the basis of a survey in WHO Member States. The main content of such regulations is discussed. The special properties of radiopharmaceuticals compared with ordinary drugs may call for modified regulations. Several countries are preparing such regulations. Close co-operation and good understanding among scientists working in hospital research, industry and regulatory bodies will be of great importance for the fast and safe introduction of new radiopharmaceuticals for the benefit of the patient. Before introducing new legislation in this field, a radiopharmaceutical expert should analyse the situation in the country and the relationship to the existing regulations. It is expected that the most important factor in promoting the fast introduction of new, safe and effective radiopharmaceuticals will be the training of people working within the regulatory bodies. It is foreseen that the IAEA and WHO will have an important role to play by providing expert advice and training in this area. (author)

  9. Eleventh international symposium on radiopharmaceutical chemistry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-12-31

    This document contains abstracts of papers which were presented at the Eleventh International Symposium on Radiopharmaceutical Chemistry. Sessions included: radiopharmaceuticals for the dopaminergic system, strategies for the production and use of labelled reactive small molecules, radiopharmaceuticals for measuring metabolism, radiopharmaceuticals for the serotonin and sigma receptor systems, labelled probes for molecular biology applications, radiopharmaceuticals for receptor systems, radiopharmaceuticals utilizing coordination chemistry, radiolabelled antibodies, radiolabelling methods for small molecules, analytical techniques in radiopharmaceutical chemistry, and analytical techniques in radiopharmaceutical chemistry.

  10. Eleventh international symposium on radiopharmaceutical chemistry

    International Nuclear Information System (INIS)

    1995-01-01

    This document contains abstracts of papers which were presented at the Eleventh International Symposium on Radiopharmaceutical Chemistry. Sessions included: radiopharmaceuticals for the dopaminergic system, strategies for the production and use of labelled reactive small molecules, radiopharmaceuticals for measuring metabolism, radiopharmaceuticals for the serotonin and sigma receptor systems, labelled probes for molecular biology applications, radiopharmaceuticals for receptor systems, radiopharmaceuticals utilizing coordination chemistry, radiolabelled antibodies, radiolabelling methods for small molecules, analytical techniques in radiopharmaceutical chemistry, and analytical techniques in radiopharmaceutical chemistry

  11. Recent advances in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Smith, S.

    2000-01-01

    Full text: Radiopharmaceuticals in Nuclear Medicine may be divided into diagnostic and therapeutic agents. The diagnostic area is perceived to be mature, while the therapeutic side of nuclear medicine is still evolving. There are over 100 diagnostic radiopharmaceutical products available, the greatest number applied in cardiology followed by oncology and neurology. The greatest success in therapeutic nuclear medicine has been achieved in thyroid cancer, hyperthyroidism and bone pain palliation. Those in the field believe the future of nuclear medicine resides in the growth potential of the emerging therapeutic market, hence much of the recent research has been focussed in the development of therapeutic agents for targeting cancers. Radiopharmaceuticals under development or in clinical trials involve the use of radionuclides such as Y-90, Pd-103, Ir-192, Re-188, I-131, Sm-153, Sn-114, Sr-90, Cu-64 and In-111. Advances in cyclotron and camera technology as well as automation has enhanced and widened the potential use of positron emitting radiopharmaceuticals such as F-18 Fluorodeoxyglucose (FDG). However the relationship between FDG uptake and glucose consumption in normal and diseased tissue is still to be defined. Many challenges remain for the nuclear medicine community to apply new knowledge of human biochemistry in the development of new radiopharmaceuticals. A better understanding of effects of radiation and its role in the design of therapeutic agents is undoubtedly pivotal for advancing therapeutic Nuclear Medicine into the future

  12. Therapeutic applications of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Baker, W.J.; Datz, F.L.; Beightol, R.W.

    1987-01-01

    Whether a radiopharmaceutical has diagnostic or therapeutic application depends on both the isotope and pharmaceutical used. For diagnostic applications, the isotope should undergo only γ-decay, since usually only γ-radiation is detected by nuclear medicine cameras. The half-life should be just long enough to allow the procedure to be performed. In contrast, the isotope needed for therapeutic purposes should have particulate radiation, such as a β-particle (electron), since these are locally absorbed an increase the local radiation dose. γ-Radiation, which penetrates the tissues, produces less radiation dose than do Β-particles. Several references dealing with radioactive decay, particulate interactions, and diagnostic and therapeutic applications of radiopharmaceuticals are available. Radiopharmaceuticals can legally be used only by physicians who are qualified by specific training in the safe handling of radionuclides. The experience and training of these physicians must be approved by the Nuclear Regulatory Commission or Agreement State Agency authorized to license the use of radiopharmaceuticals. A list of all byproduct material and procedures is available in the Code of Federal Regulations. Of the many radiopharmaceuticals available for diagnostic and therapeutic use, only those commonly used are discussed in this chapter

  13. Cyclotron produced radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kopicka, K.; Fiser, M.; Hradilek, P.; Hanc, P.; Lebeda, O.

    2003-01-01

    Some of the cyclotron-produced radionuclides may serve as important materials for the production of radiopharmaceuticals. This lecture deals with basic information relating to various aspects of these compounds. In comparison with radionuclides /compounds used for non-medical purposes, radiopharmaceuticals are subject to a broader scale of regulations, both from the safety and efficacy point of view; besides that, there are both radioactive and medical aspects that must be taken into account for any radiopharmaceutical. According to the regulations and in compliance with general rules of work with radioactivity, radiopharmaceuticals should only be prepared/manufactured under special conditions, using special areas and special equipment and applying special procedures (e.g. sterilisation, disinfection, aseptic work). Also, there are special procedures for cleaning and maintenance. Sometimes the requirements for the product safety clash with those for the safety of the personnel; several examples of solutions pertaining to these cases are given in the lecture. Also, the specific role of cyclotron radiopharmaceuticals is discussed. (author)

  14. Quality control of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1981-01-01

    Quality assurance was introduced in the pharmaceutical field long before it was used in many other areas, and the term quality control has been used in a much broader sense than merely analytical quality control. The term Good Manufacturing Practice (GMP) has been used to describe the system used for producing safe and effective drugs of a uniform quality. GMP has also been used for the industrial production of radiopharmaceuticals. For the preparation and control of radiopharmaceuticals in hospitals a similar system has been named Good Radiopharmacy Practice (GRP). It contains the same elements as GMP but takes into account the special nature of this group of drugs. Data on the assessment of the quality of radiopharmaceuticals in relation to present standards are reviewed. The general conclusion is that the quality of radiopharmaceuticals appears comparable to that of other drugs. It seems possible to establish the production of radiopharmaceuticals, generators and preparation kits in such a way that analytical control of the final product at the hospital may be limited provided the final preparation work is carried out in accordance with GRP principles. The elements of GRP are reviewed. (author)

  15. Radiopharmacy and radiopharmaceutical products

    International Nuclear Information System (INIS)

    Galy, Gerard; Fraysse, Marc; Hammadi, Akli; Tafani, Mathieu

    2012-01-01

    Written by two radio-pharmacist doctors, this book presents all the theoretical and practical knowledge necessary to radio-pharmacists in charge of the management, the preparation, the control and the delivery of radiopharmaceutical medicines. It presents the scientific, regulatory and technical foundations for the implementation and operation of radiopharmacy in hospitals, addressing themes such as the fundamentals and theories about nuclear physics and radioactivity (production of artificial radionuclides, detectors and measuring instruments, radio-chemistry), radio-biology and radiation protection (biological effects of ionizing radiations, radioprotection, regulations concerning the use of radiopharmaceutical products by medical personnel), the application domains of radiopharmaceutical medicines and products (diagnosis, therapy, biological assessment), and the management of radiopharmacy in a hospital (design, implementation, organizing, operation)

  16. Quality assurance of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Frier, M.; Hesslewood, S.R.

    1980-01-01

    A practical guide has been composed for all persons involved in the preparation and use of radiopharmaceuticals on methods used in quality assurance and their applications. These methods include the calibration of ionization chamber assay calibrators, the determination of radionuclide purity, radiochemical purity and chemical purity, particle size analysis and the measurement of pH. Quality assurance procedures are described for products not described in Compendial Monographs, or where the monograph exists, additional useful information is provided; such radiopharmaceuticals include technetium, indium-labelled and iodine-labelled products. (U.K.)

  17. Drug-radiopharmaceutical interactions

    International Nuclear Information System (INIS)

    Hladik, W.B.; Ponto, J.A.; Stathis, V.J.

    1985-01-01

    Patients seen in the nuclear medicine department have a wide variety of disorders and, consequently, may be receiving any number of therapeutic drugs. For this reason, nuclear medicine professionals should be aware of the potential effects that these pharmacologic agents may have on the bio-distribution of subsequently administered radiopharmaceuticals, commonly referred to as ''drug-radiopharmaceutical interactions.'' Compared with the quantity of literature written about interactions between various therapeutic drugs, the information available on drug-radiopharmaceutical interactions is scarce. However, there has been increasing interest in this subject, particularly during the past five years. Some of the reported interactions are used intentionally to add a new dimension to the nuclear medicine study and increase its diagnostic capabilities, i.e., pharmacologic intervention. These beneficial ''interactions'' are discussed in detail in several other chapters of this book. Other interactions, however, cause changes in the normal distribution of radiopharmaceuticals, which may interfere with the diagnostic utility of various nuclear medicine procedures. The latter group of interactions is the focus of this chapter

  18. Audits of radiopharmaceutical formulations

    International Nuclear Information System (INIS)

    Castronovo, F.P. Jr.

    1992-01-01

    A procedure for auditing radiopharmaceutical formulations is described. To meet FDA guidelines regarding the quality of radiopharmaceuticals, institutional radioactive drug research committees perform audits when such drugs are formulated away from an institutional pharmacy. All principal investigators who formulate drugs outside institutional pharmacies must pass these audits before they can obtain a radiopharmaceutical investigation permit. The audit team meets with the individual who performs the formulation at the site of drug preparation to verify that drug formulations meet identity, strength, quality, and purity standards; are uniform and reproducible; and are sterile and pyrogen free. This team must contain an expert knowledgeable in the preparation of radioactive drugs; a radiopharmacist is the most qualified person for this role. Problems that have been identified by audits include lack of sterility and apyrogenicity testing, formulations that are open to the laboratory environment, failure to use pharmaceutical-grade chemicals, inadequate quality control methods or records, inadequate training of the person preparing the drug, and improper unit dose preparation. Investigational radiopharmaceutical formulations, including nonradiolabeled drugs, must be audited before they are administered to humans. A properly trained pharmacist should be a member of the audit team

  19. Drug interactions with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Hesslewood, S.; Leung, E.

    1994-01-01

    Considerable information on documented drug and radiopharmaceutical interactions has been assembled in a tabular form, classified by the type of nuclear medicine study. The aim is to provide a rapid reference for nuclear medicine staff to look for such interactions. The initiation of drug chart monitoring or drug history taking of nuclear medicine patients and the reporting of such events are encouraged. (orig.)

  20. F-18 Radiopharmaceuticals

    International Nuclear Information System (INIS)

    2001-12-01

    This document includes 8 presentations delivered at the symposium. The topics discussed include: optimization of accelerator production of 18 F- and 18 F 2 -fluorodeoxyglucose; radiopharmaceuticals synthesis, synthesis modules, pharmacopoeia and GLP; quality control; radiation safety of production and application; PET imaging in human medicine. Each presentation has been indexed separately

  1. Radiopharmaceuticals for renal studies

    International Nuclear Information System (INIS)

    Verdera, Silvia

    1994-01-01

    Between the diagnostic techniques using radiopharmaceuticals in nuclear medicine it find renal studies.A brief description about renal glomerular filtration(GFR) and reliability renal plasma flux (ERPF),renal blood flux measurement agents (RBF),renal scintillation agents and radiation dose estimates by organ physiology was given in this study.tabs

  2. Quality control of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Verdera, E.S.

    1994-01-01

    The quality control of radiopharmaceuticals is based in physics, physics-chemical and biological controls. Between the different controls can be enumerated the following: visual aspect,side, number of particle beams,activity,purity,ph,isotonicity,sterility,radioinmunoessay,toxicity,stability and clinical essay

  3. Melanin-binding radiopharmaceuticals

    International Nuclear Information System (INIS)

    Packer, S.; Fairchild, R.G.; Watts, K.P.; Greenberg, D.; Hannon, S.J.

    1980-01-01

    The scope of this paper is limited to an analysis of the factors that are important to the relationship of radiopharmaceuticals to melanin. While the authors do not attempt to deal with differences between melanin-binding vs. melanoma-binding, a notable variance is assumed

  4. Radiopharmaceuticals for thrombus detection

    International Nuclear Information System (INIS)

    Knight, L.C.

    1990-01-01

    Most of the components of the thrombotic and fibrinolytic systems have at some time been evaluated as a means of carrying a radiolabel specifically to thrombi, although very few have been promising enough to emerge from investigational status to routine clinical use. New approaches are being explored, including improved methods of labeling platelets, chemically modified forms of previously tested plasma proteins, and new biomolecules, including monoclonal antibodies specific for fibrin and platelets. The current goal is to find one or more radiotracers that bind specifically and rapidly to thrombi, and that also have a rapid blood disappearance rate, permitting a clear diagnosis within a few hours after injection. Because this test may be needed to assess the course of therapy in an anticoagulated patient, the ideal radiopharmaceutical should be able to locate thrombi without interference by anticoagulants. Until a suitable thrombus-specific radiopharmaceutical becomes generally available, many hospitals will continue to attempt to make a diagnosis with nonspecific radiopharmaceuticals that can at best provide blood pool images to indicate filling defects. Several of the new approaches seem likely to provide the radiopharmaceutical sought, although clinical trials are at an early stage.137 references

  5. Process for preparing radiopharmaceuticals

    International Nuclear Information System (INIS)

    Barak, M.; Winchell, H.S.

    1977-01-01

    A process for the preparation of technetium-99m labeled pharmaceuticals is disclosed. The process comprises initially isolating technetium-99m pertechnetate by adsorption upon an adsorbent packing in a chromatographic column. The technetium-99m is then eluted from the packing with a biological compound to form a radiopharmaceutical

  6. Pain palliative Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Gonzalez, B. M.

    1994-01-01

    A pain relieving agents based on β emitters mainly and in some cases a complex preparation are being given for bone metastasis in relation with breast,prostate and lung carcinoma with good performance in clinical practice.Several radionuclides and radiopharmaceuticals are mentioned giving strength to those newly proposed, 153Sm and 186Re.Bibliography

  7. The development of cyclotron radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Seung Dae; Chun, K. W.; Suh, Y. S.; Lee, J. D.; Ahn, S. H. and others

    1999-03-01

    The purpose of this project is to developthe radiopharmaceuticals and automatic synthetic unit for labelled compounds, and to establish mass production system of radiopharmaceuticals. These will contribute to the early diagnosis of the disease hard to cure. The contents of this project are as follows, the development of the radiopharmaceutical for imaging of cancer, the development of automatic synthesizer for the synthesis of radio-pharmaceuticals, the development of hormone derivatives labelled with {sup 12}'3I, the development of the radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for therapy of cancer labelled with cyclotron produced radionuclides, the development of radiopharmaceuticals for imaging of myocardial metabolism.

  8. Direct astatination of a tumour-binding protein, human epidermal growth factor, using nido-carborane as a prosthetic group

    International Nuclear Information System (INIS)

    Sjoestroem, A.; Carlsson, J.; Lundqvist, H.; Koziorowski, J.

    2003-01-01

    A method for direct astatine labeling of proteins has been investigated. Binding sites for astatine were created by coupling of a nido-carborane derivative to a protein, the human epidermal growth factor (hEGF), using two different conjugation methods - by glutaraldehyde cross-linking or by introduction of sulfohydryl groups by Traut's reagent with subsequent linking of ANC-1 with m-maleimidobenzoyl-N-hydroxysulfosuccinimide ester. The conjugates were astatinated using the Chloramine-T method in high yield. The best labeling was obtained by the glutaraldehyde conjugate with an average yield of 68 ± 9%. In vitro stability tests indicated that the glutaraldehyde conjugated label was as stable as hEGF labeled with astatobenzoate. (author)

  9. Radiopharmaceuticals in Czechoslovakia

    International Nuclear Information System (INIS)

    Hron, M.; Kronrad, L.; Svoboda, K.; Melichar, F.

    1986-01-01

    The history is briefly described of the production of radiopharmaceuticals in Czechoslovakia for nuclear medicine purposes. 131 I-labelled orthoiodohippurate and rose Bengal were first produced. Currently, 99m Tc is the most frequently requested radionuclide for radiopharmaceutical labelling. The preparation of 99m Tc is described in detail, a flow chart is shown and the network of 99m Tc distribution to hospitals outlined. In addition of 99m Tc and 131 I, UJV Rez produces other radionuclides for nuclear medicine, such as 113m In, 67 Ga, 35 S, 32 P, 203 Hg, 85 Sr. The methods are being developed of the production of 201 Tl, 125 I and 131 I-labelled bromosulfophthalein. (E.S.)

  10. Radioisotopes and radiopharmaceuticals catalogue

    International Nuclear Information System (INIS)

    2002-01-01

    The Chilean Nuclear Energy Commission (CCHEN) presents its radioisotopes and radiopharmaceuticals 2002 catalogue. In it we found physical characteristics of 9 different reactor produced radioisotopes ( Tc-99m, I-131, Sm-153, Ir-192, P-32, Na-24, K-42, Cu-64, Rb-86 ), 7 radiopharmaceuticals ( MDP, DTPA, DMSA, Disida, Phitate, S-Coloid, Red Blood Cells In-Vivo, Red Blood Cells In-Vitro) and 4 labelled compounds ( DMSA-Tc99m, DTPA-Tc99m, MIBG-I131, EDTMP-Sm153 ). In the near future the number of items will be increased with new reactor and cyclotron products. Our production system will be certified by ISO 9000 on March 2003. CCHEN is interested in being a national and an international supplier of these products (RS)

  11. Good radiopharmaceuticals practices

    International Nuclear Information System (INIS)

    Verdera E, Silvia

    1994-01-01

    A careful security must be used in the nuclear medicine laboratory concerning to the proceedings, preparation and dispensation of radiopharmaceuticals. Each control laboratory must look after the radiation protection patients,workers and people in general. Between another routinary activities in the present work it find : equipment prearrangement,installations,handling and support of electronic instruments,proceedings,methodology, results and interpretation of analysis , as well as registry maintenance

  12. Radiopharmaceuticals for diagnosis

    International Nuclear Information System (INIS)

    Kuhl, D.E.

    1990-06-01

    During this grant period 1 January 1988--31 December 1990, we have successfully developed a number of new approaches to fluorine-18 labeled compounds, prepared several new radiotracers for both animal studies and eventual clinical trials, and explored the utility of a high-quality industrial robot in radiopharmaceutical applications. The progress during the last grant period is summarized briefly in the following sections. Publications arising from this research are listed below and can be found in Appendix I. 1 fig

  13. Estimation of the chemical form and the boiling point of elementary astatine by radiogas-chromatography

    International Nuclear Information System (INIS)

    Otozai, K.; Takahashi, N.

    1982-01-01

    After astatine (0) was mixed with 131 I 2 containing carrier I 2 , the sample was analyzed by means of radiogaschromatography and the peaks due to I 2 , AtI and At 2 were observed. Further, the boiling points were estimated from the retention volume in terms of the semi-empirical theory on gas chromatography. The boiling points of I 2 , AtI and At 2 were 457 +- 2,486 +- 2 and 503 +- 3K, respectively. The boiling point of At 2 obtained in the present work is far smaller than that expected by the extrapolation of lighter halogens. (orig.)

  14. Supply of radiopharmaceuticals in Japan

    International Nuclear Information System (INIS)

    Genka, Tsuguo

    2006-01-01

    Detailed statistics of the application of radiopharmaceuticals in nuclear medicine in Japan are summarized. They are the amount of supply in terms of monetary value and radioactivity, categorized usages of in vivo and in vitro, number of facilities using the radiopharmaceuticals for the time span of 5 years (1998-2002). Obvious tendency of decrease for in vitro use can be seen while the total amount of radiopharmaceuticals is almost unchanged. (author)

  15. Direct astatination of a tumour-binding protein, human epidermal growth factor, using nido-carborane as a prosthetic group

    Czech Academy of Sciences Publication Activity Database

    Sjostrom, A.; Tolmachev, V.; Lebeda, Ondřej; Koziorowski, J.; Carlsson, J.; Lundqvist, H.

    2003-01-01

    Roč. 256, č. 7 (2003), s. 191-197 ISSN 0236-5731 R&D Projects: GA AV ČR KSK4055109 Keywords : neutron-capture therapy * astatine-211 Subject RIV: CH - Nuclear ; Quantum Chemistry Impact factor: 0.472, year: 2003

  16. Radiopharmaceuticals - current state and trends

    International Nuclear Information System (INIS)

    Muenze, R.

    1981-07-01

    The current state as well as the tendencies of modern radiopharmaceutical development and application is reviewed. After an evaluation of the fundamental preconditions of decay characteristics and pharmaceutical properties the problems concerning sup(99m)Tc-radiopharmaceuticals, metabolizable compounds and the use of specific biological interactions are discussed. (author)

  17. The hospital preparation of radiopharmaceuticals

    International Nuclear Information System (INIS)

    The subject is covered in sections: introduction; preparation ((general - sterilization), production areas (laboratories), working methods for injections, working methods for oral preparations and iodination procedures); analytical testing (general, standards common to injections and oral preparations, standards for injections, standards for oral preparations); reliable methods of preparing sup(99m)Tc-radiopharmaceuticals and 51 Cr-red cells; commercial radiopharmaceutical kits. (U.K.)

  18. Cyclotrons and positron emitting radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Wolf, A.P.; Fowler, J.S.

    1984-01-01

    The state of the art of Positron Emission Tomography (PET) technology as related to cyclotron use and radiopharmaceutical production is reviewed. The paper discusses available small cyclotrons, the positron emitters which can be produced and the yields possible, target design, and radiopharmaceutical development and application. 97 refs., 12 tabs. (ACR)

  19. Placental transfer of selected radiopharmaceuticals

    International Nuclear Information System (INIS)

    Wegst, A.V.

    1992-01-01

    This paper reviews animal experiments carried out to determine the transfer of radiopharmaceuticals from mother to fetus. Animal data are compared to any human data available. The radiopharmaceuticals included in the discussion are Tc-99m pertechnetate, Tc-99m DTPA, Ga-67 citrate and Tl-201 chloride. (6 tab., 5 refs.)

  20. Cyclotrons and positron emitting radiopharmaceuticals

    International Nuclear Information System (INIS)

    Wolf, A.P.; Fowler, J.S.

    1984-01-01

    The state of the art of Positron Emission Tomography (PET) technology as related to cyclotron use and radiopharmaceutical production is reviewed. The paper discusses available small cyclotrons, the positron emitters which can be produced and the yields possible, target design, and radiopharmaceutical development and application. 97 refs., 12 tabs

  1. Radioisotope and radiopharmaceutical generators

    International Nuclear Information System (INIS)

    Barak, M.; Winchell, H.W.

    1975-01-01

    A chromatographic column for generating technetium-99m isotopes and technetium-99m labeled pharmaceuticals in a simple two-step process is described. Technetium-99m pertechnetate in a first step is isolated by adsorption upon an adsorbent packing. Then the technetium-99m in a second step is eluted from the packing, either with an immediately labeled biological compound to form a radiopharmaceutical, or by a controlled volume of eluant to produce a 99m-technetium-bearing eluate of a desired specific concentration. (Official Gazette)

  2. Development of new radiopharmaceuticals

    International Nuclear Information System (INIS)

    1989-12-01

    The possibilities to design and prepare better and more organ-specific radiopharmaceuticals for diagnostic nuclear medicine has increased dramatically in the recent past with a deeper understanding of the relationships between chemical structure and biological activity. Whereas most of the research is performed in well-funded laboratories of industrialized countries, there are several developing countries with adequate resources and expertise as to undertake fruitful research in the field of radiopharmacy. With the aim of promoting advanced research in radiopharmacy by developing new radiodiagnostics agents, in particular, hepatobiliary imaging agents labelled with 99m Tc, and to facilitate exchange of information, the IAEA has established in 1983 the present Research Co-ordination Programme (CRP) with a duration of five years. The report includes detailed results obtained by all participants as well as novel preparation procedures for some of the newest and more promising radiopharmaceuticals developed under the auspices of the CRP. The extensive bibliographic reference listing is considered another important information of particular value for scientists in developing countries who do not always have access to updated scientific information sources. Refs, figs and tabs

  3. Molecularly targeted therapeutic radiopharmaceuticals

    International Nuclear Information System (INIS)

    Saw, M.M.

    2007-01-01

    Full text: It is generally agreed that current focus of nuclear medicine development should be on molecular imaging and therapy. Though, the widespread use of the terminology 'molecular imaging' is quite recent, nuclear medicine has used molecular imaging techniques for more than 20 years ago. A variety of radiopharmaceuticals have been introduced for the internal therapy of malignant and inflammatory lesions in nuclear medicine. In the field of bio/medical imaging, nuclear medicine is one of the disciplines which has the privilege of organized and well developed chemistry/ pharmacy section; radio-chemistry/radiopharmacy. Fundamental principles have been developed more than 40 years ago and advanced research is going well into postgenomic era. The genomic revolution and dramatically increased insight in the molecular mechanisms underlying pathology have led to paradigm shift in drug development. Likewise does in the nuclear medicine. Here, the author will present current clinical and pre-clinical therapeutic radiopharmaceuticals based on molecular targets such as membrane-bound receptors, enzymes, nucleic acids, sodium iodide symporter, etc, in correlation with fundamentals of radiopharmacy. (author)

  4. 188Re(V) Nitrido Radiopharmaceuticals for Radionuclide Therapy.

    Science.gov (United States)

    Boschi, Alessandra; Martini, Petra; Uccelli, Licia

    2017-01-19

    The favorable nuclear properties of rhenium-188 for therapeutic application are described, together with new methods for the preparation of high yield and stable 188 Re radiopharmaceuticals characterized by the presence of the nitride rhenium core in their final chemical structure. 188 Re is readily available from an 188 W/ 188 Re generator system and a parallelism between the general synthetic procedures applied for the preparation of nitride technetium-99m and rhenium-188 theranostics radiopharmaceuticals is reported. Although some differences between the chemical characteristics of the two metallic nitrido fragments are highlighted, it is apparent that the same general procedures developed for the labelling of biologically active molecules with technetium-99m can be applied to rhenium-188 with minor modification. The availability of these chemical strategies, that allow the obtainment, in very high yield and in physiological condition, of 188 Re radiopharmaceuticals, gives a new attractive prospective to employ this radionuclide for therapeutic applications.

  5. 188Re(V) Nitrido Radiopharmaceuticals for Radionuclide Therapy

    Science.gov (United States)

    Boschi, Alessandra; Martini, Petra; Uccelli, Licia

    2017-01-01

    The favorable nuclear properties of rhenium-188 for therapeutic application are described, together with new methods for the preparation of high yield and stable 188Re radiopharmaceuticals characterized by the presence of the nitride rhenium core in their final chemical structure. 188Re is readily available from an 188W/188Re generator system and a parallelism between the general synthetic procedures applied for the preparation of nitride technetium-99m and rhenium-188 theranostics radiopharmaceuticals is reported. Although some differences between the chemical characteristics of the two metallic nitrido fragments are highlighted, it is apparent that the same general procedures developed for the labelling of biologically active molecules with technetium-99m can be applied to rhenium-188 with minor modification. The availability of these chemical strategies, that allow the obtainment, in very high yield and in physiological condition, of 188Re radiopharmaceuticals, gives a new attractive prospective to employ this radionuclide for therapeutic applications. PMID:28106830

  6. Radiopharmaceuticals in Radiosynoviorthesis

    International Nuclear Information System (INIS)

    Cruz Arencibia, Jorge; Morin Zorrilla, Jose; Garcia Rodriguez, Enrique; Sagarra Veranes, Marta

    2010-01-01

    The Radiosynoviorthesis is a procedure of Metabolic Radiotherapy, consisting in the intraarticular injection of a radiopharmaceutical with a beta emitting radionuclide for the treatment of chronic synovitis, frequently present in rheumatoid arthritis, haemophilia and other systemic diseases. As this is a safe, effective and a relatively low-cost procedure, It is ordinarily used in Europe, USA and in some Latin American countries . The existing commercial products are based on 90 Y, 169 Er, 186 Re and 32 P, although research is carried out on the use of 188 Re, 166 Ho, among others radionuclides. In Cuba a suspension of Chromium Phosphate (III) labeled with 32 P, is on trial. The above-mentioned suspension has enough characteristics to become an efficient and safe product in practice. (Author)

  7. Organic radiopharmaceuticals: recent advances

    International Nuclear Information System (INIS)

    Wolf, A.P.; Fowler, J.S.

    1979-01-01

    Organic radiopharmaceuticals are considered in light of accelerator and nuclide production requirements, special problems relating to the carrier-free state, including terminology, of the special technology required to prepare and manipulate these compounds and new trends in compound design and synthesis. The emphasis is on medical cyclotrons and the positron-emitting radionuclides, carbon-11, nitrogen-13, oxygen-15, and fluorine-18. New routes to synthetic precursors and organic compounds of high specific activity labeled with carbon-11, fluorine-18, and iodine-123 including monosaccharides, aromatic amines, neuroleptics, fatty acids, steroids, and other classes of compounds are discussed. Some compounds are considered in terms of the development and evaluation of structure-activity relationships and including some newer concepts such as metabolic trapping. 67 references

  8. Radiopharmaceuticals good practices handbook: ARCAL XV radiopharmaceuticals control and production

    International Nuclear Information System (INIS)

    Verdera Presto, Silvia

    1998-01-01

    A safety practice of the therapeutics diagnostic proceeding in nuclear medicine require a permanent provide high quality radiopharmaceuticals manufacture. This work treat to give a guide for all radio pharmacies laboratories that produce,control, fraction and or dispense radiopharmaceuticals products, with attention hospitable radiopharmacy laboratory. Three chapters with recommendations in manufacture good practice in Hospital radiopharmacy, industrial centralized, bibliography and three annexe's about clean area classification,standards work in laminar flux bell, and guarantee and cleaning areas

  9. Radiopharmaceuticals in breast milk

    International Nuclear Information System (INIS)

    Mountford, P.J.; Coakley, A.J.

    1986-01-01

    As assessment has been made of the radiological hazards to an infant following the administration of a radiopharmaceutical to a breast feeding mother. Feeding should be discontinued after administration of most I-131 and I-125 compounds, Ga-67 citrate or Se-78 methionine, and for iodinated compounds where it was possible to resume feeding, a thyroid-blocking agent should be administered. For Tc-99m compounds, pertechnetate had the greatest excretion in milk and interruptions of 12hr and 4hr were considered appropriate for pertechnetate and MAA respectively. Other Tc-99m compounds, Cr-51 EDTA and In-111 leucocytes did not justify an interruption just on the grounds of their associated excretion in milk. The ingestion hazard could be minimized by reducing the administered activity, and in some cases, by the substitution of a radiopharmaceutical with lower breast milk excretion. For Tc-99m lung and brain scans, the absorbed dose due to radiation emitted by the mother (i.e. when cuddling) was less than the ingested dose, but for a Tc-99m bone scan the emitted dose was greater. In all three cases, the emitted dose did not exceed 0 x 5 mGy for the infant in close contact to the mother for one-third of the time. For In-111 leucocytes, the emitted dose was about 2mGy, and it was concluded that close contact should be restricted to feeding times during the first 3 days after injection. 36 references, 2 figures, 5 tables

  10. Laser photodetachment of radioactive ions: towards the determination of the electronegativity of astatine

    CERN Multimedia

    Rothe, Sebastian; Welander, Jakob Emanuel; Chrysalidis, Katerina; Day Goodacre, Thomas; Fedosseev, Valentine; Fiotakis, Spyridon; Forstner, Oliver; Heinke, Reinhard Matthias; Johnston, Karl; Kron, Tobias; Koester, Ulli; Liu, Yuan; Marsh, Bruce; Ringvall Moberg, Annie; Rossel, Ralf Erik; Seiffert, Christoph; Studer, Dominik; Wendt, Klaus; Hanstorp, Dag

    2017-01-01

    Negatively charged ions are mainly stabilized through the electron correlation effect. A measure of the stability of a negative ion is the electron affinity, which the energy gain by attaching an electron to a neutral atom. This fundamental quantity is, due to the almost general lack of bound excited states, the only atomic property that can be determined with high accuracy for negative ions. We will present the results of the first laser photodetachment studies of radioactive negative ions at CERN-ISOLDE. The photodetachment threshold for the radiogenic iodine isotope 128I was measured successfully, demonstrating the performance of the upgraded GANDALPH experimental beam line. The first detection of photo-detached astatine atoms marks a milestone towards the determination of the EA of this radioactive element.

  11. Thermogravimetric determination of the enthalpy of astatine and radon adsorption on palladium surfaces

    International Nuclear Information System (INIS)

    Eichler, B.; Son Chun, K.

    1985-01-01

    In order to investigate the adsorption of astatine and radon on a palladium surface some on- and off-line thermochromatographic experiments were carried out with 210 At and 220 Rn tracers. The partial molar adsorption enthalpy for zero covering was found to be ΔH/sub a//sup 0, loc./(At) = -(15S +- 10) kJ mole -1 and ΔH/sub a//sup 0, mob./(Rn) = -(37 +- 4) kJ mole -1 . The results are compared with theoretical and experimental values for other elements of the sixth period. The adsorption behaviour of At is in conformity with that of the p-metals on a palladium surface. (author)

  12. Determination of the electron affinity of astatine and polonium by laser photodetachment

    CERN Multimedia

    We propose to conduct the first electron affinity (EA) measurements of the two elements astatine (At) and polonium (Po). Collinear photo-detachment spectroscopy will allow us to measure these quantities with an uncertainty limited only by the spectral line width of the laser. We plan to use negative ion beams of the two radioactive elements At and Po, which are only accessible on-line and at ISOLDE. The feasibility of our proposed method and the functionality of the experimental setup have been demonstrated at ISOLDE in off-line tests by the clear observation of the photo-detachment threshold for stable iodine. This proposal is based on our Letter of Intent I-148.

  13. Experimental nuclear medicine radiopharmaceutical development

    International Nuclear Information System (INIS)

    Harper, P.; Lathrop, K.

    1980-01-01

    This report summarizes progress that has been made on the preparation and biological accumulation of various radiopharmaceuticals including C-hexamethonium, C-cholic acid, Mn-51 and labeled amino acids

  14. Teaching and research in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Wiebe, L.I.

    1998-01-01

    Radiopharmaceuticals comprise a critical element of diagnostic and therapeutic clinical nuclear medicine. As well they contribute to more basic pre-clinical and clinical diagnostic studies such as the evaluation of new drugs and new drug formulations. Their development and utilization is based on the complex interaction of a number of disciplines including medicine, pharmacy, biochemistry, pharmacology, chemistry, physics and engineering. This technically-complex multidisciplinary base has impeded the development of a uniform curriculum of training for basic scientists and professionals who work with radiopharmaceuticals. the range of technical knowledge required is very broad; it ranges from chemical synthesis and radiolabelling, through a maze of biochemistry, pharmacology and now molecular biology, to GMP manufacture, dispensing and clinical consultation concerning use and interpretation of data. Clearly, no single discipline can (nor should) be expected to undertake in-depth training of radiopharmaceutical scientists, but equally clearly, there is need for the development of curricula that will develop specific components of the essential knowledge base. The 'radiopharmaceutical' or 'product' orientation of both teaching and research can be used to provide a focus for academic and professional organizations to develop 'radiopharmacy' curricula that effectively train radiopharmaceutical practitioners for specific roles within the clinical, academic, government and industrial interests of radiopharmaceutical scientists. Currently, there is a plethora of segmented training programs, many of which are inadequately positioned to be of great value to the field or its practitioners. Efforts to re-focus radiopharmacy programs and to build professional recognition for them are bringing about harmonization of performance objectives, and leading to didactic and experiential curricula. The impact and evolution of regulatory processes will demand new and better

  15. Teaching and research in radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Wiebe, L I [Noujaim Institute for Pharmaceutical Oncology Research, University of Alberta, Edmonton (Canada)

    1998-08-01

    Radiopharmaceuticals comprise a critical element of diagnostic and therapeutic clinical nuclear medicine. As well they contribute to more basic pre-clinical and clinical diagnostic studies such as the evaluation of new drugs and new drug formulations. Their development and utilization is based on the complex interaction of a number of disciplines including medicine, pharmacy, biochemistry, pharmacology, chemistry, physics and engineering. This technically-complex multidisciplinary base has impeded the development of a uniform curriculum of training for basic scientists and professionals who work with radiopharmaceuticals. the range of technical knowledge required is very broad; it ranges from chemical synthesis and radiolabelling, through a maze of biochemistry, pharmacology and now molecular biology, to GMP manufacture, dispensing and clinical consultation concerning use and interpretation of data. Clearly, no single discipline can (nor should) be expected to undertake in-depth training of radiopharmaceutical scientists, but equally clearly, there is need for the development of curricula that will develop specific components of the essential knowledge base. The `radiopharmaceutical` or `product` orientation of both teaching and research can be used to provide a focus for academic and professional organizations to develop `radiopharmacy` curricula that effectively train radiopharmaceutical practitioners for specific roles within the clinical, academic, government and industrial interests of radiopharmaceutical scientists. Currently, there is a plethora of segmented training programs, many of which are inadequately positioned to be of great value to the field or its practitioners. Efforts to re-focus radiopharmacy programs and to build professional recognition for them are bringing about harmonization of performance objectives, and leading to didactic and experiential curricula. The impact and evolution of regulatory processes will demand new and better

  16. Development of radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Park, Kyung Bae; Kim, J R; Shin, B C; Kim, Y M; Cho, U K; Han, K H; Chung, Y J; Shin, H Y; Hong, S B

    1997-09-01

    To overcome many problems caused by external radiation therapy, we have developed a new agent for internal radiation therapy, which is administered directly to the lesions and irradiate {beta}-rays resulting in maximized therapeutic effect and minimized radiation damage to normal tissues or organs to nearby. In the same reasons, we have also developed a new radioactive patch for the treatment of skin cancer using {beta}-emitting radionuclide. We prepared for {sup 166}Ho-chitosan complex ({sup 166}Ho-CHICO) which is potential radiopharmaceuticals for the treatment of liver cancer, peritoneal cancer metastasized from stomach cancer, ovarian cancer, and rheumatoid arthritis in knee joints. We carried out various experiments such as evaluation of absorbed dosimetry, studies on absorption, distribution, metabolism, and excretion (ADME) and clinical trials with {sup 166}Ho-CHICO. For commercialization of {sup 166}Ho-CHICO, we evaluated its toxicity, efficacy and safety, and then prepared documents for submission to the Mininstry of Health and Welfare to get license as an investigational new drug. {sup 166}Ho-Patch for skin cancer treatment was prepared by neutron irradiation of pre-made non-radioactive {sup 165}Ho-Patch. We evaluated the efficacy and safety of {sup 166}Ho-Patch in the treatment of skin cancer using an animal model and in clinical cases. (author). 49 refs., 15 tabs., 36 figs.

  17. Development of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Park, Kyung Bae; Kim, J. R.; Shin, B. C.; Kim, Y. M.; Cho, U. K.; Han, K. H.; Chung, Y. J.; Shin, H. Y.; Hong, S. B.

    1997-09-01

    To overcome many problems caused by external radiation therapy, we have developed a new agent for internal radiation therapy, which is administered directly to the lesions and irradiate β-rays resulting in maximized therapeutic effect and minimized radiation damage to normal tissues or organs to nearby. In the same reasons, we have also developed a new radioactive patch for the treatment of skin cancer using β-emitting radionuclide. We prepared for 166 Ho-chitosan complex ( 166 Ho-CHICO) which is potential radiopharmaceuticals for the treatment of liver cancer, peritoneal cancer metastasized from stomach cancer, ovarian cancer, and rheumatoid arthritis in knee joints. We carried out various experiments such as evaluation of absorbed dosimetry, studies on absorption, distribution, metabolism, and excretion (ADME) and clinical trials with 166 Ho-CHICO. For commercialization of 166 Ho-CHICO, we evaluated its toxicity, efficacy and safety, and then prepared documents for submission to the Mininstry of Health and Welfare to get license as an investigational new drug. 166 Ho-Patch for skin cancer treatment was prepared by neutron irradiation of pre-made non-radioactive 165 Ho-Patch. We evaluated the efficacy and safety of 166 Ho-Patch in the treatment of skin cancer using an animal model and in clinical cases. (author). 49 refs., 15 tabs., 36 figs

  18. New blood flow radiopharmaceutical

    International Nuclear Information System (INIS)

    Sargent, T. III; Shulgin, A.T.; Mathis, C.A.; Budinger, T.F.

    1983-01-01

    Our program for research into the causes of mental disorders such as schizophrenia, manic depressive illness and senile dementia has led us to the development of a new radiopharmaceutical agent, IDNNA (4-iodo-2,5-dimethoxy-N,N-dimethylamphetamine). A series of some 15 different 131 I labeled molecules with various substitutions on the amine were synthesized and tested, and the uptake of the 131 I labeled conpounds in rats was measured. The dimethyl amine (IDNNA) had the best brain uptake and brain/blood ratio. When injected into a dog and scanned with a whole-body scanner, the uptake in the brain could be clearly seen and quantified. Plasma sampling at the same time showed that the maximum brain/blood ratio of 8.7 occurred at 8 min after injection, and the concentration in brain remained high for at least 15 min. Labeling is achieved by reacting 131 ICl and the precursor, 2,5-dimethoxy-N,N-dimethyl amphetamine, in glacial acetic acid; the reaction is complete in less than one minute

  19. Radiopharmaceuticals targeting melanoma

    Energy Technology Data Exchange (ETDEWEB)

    Pham, T.Q.; Berghofer, P.; Liu, X.; Greguric, I.; Dikic, B.; Ballantyne, P.; Mattner, F.; Nguyen, V.; Loc' h, C.; Katsifis, A. [Radiopharmaceuticals Research Institute, Australian Nuclear Science and Technology Organisation, Menai, N.S.W., Sydney (Australia)

    2008-02-15

    Melanoma is one of the most aggressive cancers known with a high rate of mortality and increasing global incidence. So, the development of radiopharmaceuticals for either diagnostic or therapeutic purposes could make enormous contributions to melanoma patient health care. We have been studying melanoma tumours through several targeting mechanisms including melanin or specific receptor based radiopharmaceuticals Structure activity studies indicate that the substitution patterns on radioiodinated benzamides significantly influence the uptake mechanism from melanin to sigma-receptor binding. Furthermore, the position of the iodine as well as the presence of key functional groups and substituents has resulted in compounds with varying degrees of activity uptake and retention in tumours. From these results, a novel molecule 2-(2-(4-(4-iodo benzyl)piperazin-1-yl)-2-oxo-ethyl)isoindoline- 1,3-dione (M.E.L.037) was synthesized, labelled with iodine-123 and evaluated for application in melanoma tumour scintigraphy and radiotherapy. The tumour imaging potential of {sup 123}IM.E.L.037 was studied in vivo in C.57 B.L./ 6 J female mice bearing the B.16 F.0. murine melanoma tumour and in BALB/c nude mice bearing the A.375 human amelanotic melanoma tumour by biodistribution, competition studies and by SPECT imaging. {sup 123}I-M.E.L.037 exhibited high and rapid uptake in the B.16 F.0 melanoma tumour at 1 h (13 % I.D./g) increasing with time to reach 25 % I.D./g at 6 h. A significant uptake was also observed in the eyes (2% I.D., at 3-6 h p.i.) of black mice. No uptake was observed in the tumour or in the eyes of nude mice bearing the A.375 tumour. Due to high uptake and long retention in the tumour and rapid body clearance, standardized uptake values(S.U.V.) of {sup 123}I-M.E.L.037 were 30 and 60, at 24 and 48 h p.i.,respectively. SPECT imaging of mice bearing the B.16 melanoma indicated the radioactivity was predominately located in the tumour followed by the eyes, while no

  20. Radiopharmaceuticals for hepatobiliary imaging

    International Nuclear Information System (INIS)

    Chervu, L.R.; Nunn, A.D.; Loberg, M.D.

    1982-01-01

    Tests for liver function have by and large centered around clinical laboratory diagnostic procedures for a number of years. Besides these, radiographic imaging procedures, including oral cholecystography and intravenous cholangiography, serve a very useful purpose, but several of them are invasive and involve a certain degree of risk from the administered contrast media as well as discomfort to the patient. The cholescintigraphic procedures, though noninvasive, have not played a significant role in the evaluation of hepatobiliary disorders prior to the introduction of the currently available /sup 99m/Tc-labeled IDAs. These new hepatobiliary agents offer many advantages over the previously utilized radiopharmaceuticals ( 131 I-rose bengal in particular) in terms of the high degree of specificity for localization in the gallbladder with rapid extraction rates by the polygonal cells of the liver and very low excretion via the GU tract. A detailed understanding of the structure distribution relationship of the various groups in the complex enable the design of agents with an improvement in hepatobiliary specificity and other desirable characteristics. In many clinical situations, even in patients with high bilirubin levels, the /sup 99m/Tc-labeled IDAs offer far superior clinical information over the alternative diagnostic imaging modalities. Further, the absorbed radiation dose imparted to the critical organs is far lower than with the older agents. Thus, the introduction of the cholescintigraphic procedures with the /sup 99m/Tc-labeled IDAs have ushered in a new phase in the diagnostic workup of patients with impaired hepatocellular function and other biliary disorders

  1. Radiochemical stability of radiopharmaceutical preparations

    International Nuclear Information System (INIS)

    Martins, Patricia de A.; Silva, Jose L. da; Ramos, Marcelo P.S.; Oliveira, Ideli M. de; Felgueiras, Carlos F.; Herrerias, Rosana; Zapparoli Junior, Carlos L.; Mengatti, Jair; Fukumori, Neuza T.O.; Matsuda, Margareth M.N.

    2011-01-01

    The 'in vitro' stability studies of the radiopharmaceutical preparations are an essential requirement for routine practice in nuclear medicine and are an important parameter for evaluating the quality, safety and efficacy required for the sanitary registration of pharmaceutical products. Several countries have published guidelines for the evaluation of pharmaceutical stability. In Brazil, the stability studies should be conducted according to the Guide for Conducting Stability Studies published in the Resolution-RE n. 1, of 29th July 2005. There are also for radiopharmaceutical products, two specific resolutions: RDC-63 regulates the Good Manufacturing Practices for Radiopharmaceuticals and RDC-64 provides the Registration of Radiopharmaceuticals, both published on the 18th December 2009. The radiopharmaceutical stability is defined as the time during which the radioisotope can be safely used for the intended purpose. The radiochemical stability can be affected by a variety of factors, including storage temperature, amount of radioactivity, radioactive concentration, presence or absence of antioxidants or other stabilizing agents. The radiochemical stability studies must be established under controlled conditions determined by the effective use of the product. The aim of this work was to evaluate the radiochemical stability of labeled molecules with 131 I, 123 I, 153 Sm, 18 F, 51 Cr, 177 Lu and 111 In as well as 67 Ga and 201 Tl radiopharmaceuticals. Radiochemical purity was evaluated after production and in the validity period, with the maximum activity and in the recommended storage conditions. The analyses were carried out by thin-layer silica gel plate, paper chromatography and gel chromatography. The experimental results showed to be in accordance with the specified limits for all the analysed products. (author)

  2. Gallium and copper radiopharmaceutical chemistry

    International Nuclear Information System (INIS)

    Green, M.A.

    1991-01-01

    Gallium and copper radionuclides have a long history of use in nuclear medicine. Table 1 presents the nuclear properties of several gallium and copper isotopes that either are used in the routine practice of clinical nuclear medicine or exhibit particular characteristics that might make them useful in diagnostic or therapeutic medicine. This paper will provide some historic perspective along with an overview of some current research directions in gallium and copper radiopharmaceutical chemistry. A more extensive review of gallium radiopharmaceutical chemistry has recently appeared and can be consulted for a more in-depth treatment of this topic

  3. Prenatal radiation doses from radiopharmaceuticals

    International Nuclear Information System (INIS)

    Rojo, A.M.; Gomez Parada, I.M.; Di Trano, J.L.

    1998-01-01

    The radiopharmaceutical administration with diagnostic or therapeutic purpose during pregnancy implies a prenatal radiation dose. The dose assessment and the evaluation of the radiological risks become relevant due to the great radiosensitivity of the fetal tissues in development. This paper is a revision of the available data for estimating fetal doses in the cases of the more frequently used radiopharmaceuticals in nuclear medicine, taking into account recent investigation in placental crossover. The more frequent diagnostic and therapeutic procedures were analyzed according to the radiation doses implied. (author) [es

  4. Radiopharmaceuticals for palliative therapy pain

    International Nuclear Information System (INIS)

    Gaudiano, Javier

    1994-01-01

    Dissemination to bone of various neoplasms is cause of pain with poor response by major analgesics.Indications. Radiopharmaceuticals,description of main characteristics of various β emitter radionuclides.Choose of patients for worm indication of pain palliative therapy with β emitter radiopharmaceuticals is adequate must be careful . Contraindications are recognized.Pre and post treatment controls as clinical examination and complete serology are described.It is essential to subscribe protocols,keep patient well informed,included the physician in charge of the patient as part of the team.Bibliography

  5. Specific GMP guidelines for radiopharmaceutical products

    International Nuclear Information System (INIS)

    2000-01-01

    These guidelines are intended to complement those provided in ''Good manufacturing practices for pharmaceutical products'', as well as the GMP for sterile pharmaceutical products. The regulatory procedures necessary to control radiopharmaceutical products are in large part determined by the sources of products and methods of manufacture. Manufacturing procedures within the scope of these guidelines include: preparation of radiopharmaceuticals in hospital radiopharmacies, preparation of radiopharmaceuticals in centralized radiopharmacies, production of radiopharmaceuticals in nuclear centres, institutes or industrial manufacturers, preparation and production of radiopharmaceuticals in Positron Emission Tomography (PET) centres

  6. The radiopharmaceutical industry and European Union regulations

    International Nuclear Information System (INIS)

    Fallais, C.J.; Sivewright, S.; Ogle, J.R.

    1997-01-01

    After a brief historical introduction to Council Directives relating to the manufacture of radiopharmaceuticals the work of the Association of Radiopharmaceuticals Producers - Europe (ARPE) is discussed. ARPE has played a significant role as an officially recognized interlocutor with the EEC, influencing decisions on the registration of radiopharmaceuticals and labelling; this role is reviewed and difficulties identified. The future of radiopharmaceuticals is then considered; it is emphasized that harmonization of national laws by the European Council would represent a first step to enabling radiopharmaceutical manufacturers to access the largest possible market for their products. (orig.)

  7. Peptide radiopharmaceuticals in nuclear medicine

    International Nuclear Information System (INIS)

    Blok, D.; Vermeij, P.; Feitsma, R.I.J.; Pauwels, E.J.K.

    1999-01-01

    This article reviews the labelling of peptides that are recognised to be of interest for nuclear medicine or are the subject of ongoing nuclear medicine research. Applications and approaches to the labelling of peptide radiopharmaceuticals are discussed, and drawbacks in their development considered. (orig.)

  8. Radiochemistry in nuclear medicine. Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Samochocka, K.

    1999-01-01

    Radionuclides and radiopharmaceuticals play a kay role in nuclear medicine, both in diagnostics and therapy. Incorporation of radionuclides into biomolecules, and syntheses of radiolabelled compounds of high biological selectivity are a task for radiochemists working in the multidisciplinary field of radiopharmaceutical chemistry. The most commonly used radionuclide, 99m Tc, owes this popularity to its both nearly ideal nuclear properties in respect to medical imaging, and availability from inexpensive radionuclide generators. Also numerous other radionuclides are widely used for medical imaging and therapy. Labelling of biomolecules with radioiodine and various positron emitters is getting increasingly important. This review describes some chemical and radiochemical problems we meet while synthesizing and using 99m Tc-radiopharmaceuticals and radioiodine-labelled biomolecules. Also represented are the recent developments in the design and use of the second generation radiopharmaceuticals based on bifunctional radiochelates. Several principal routes of fast chemical synthesis concerning incorporation of short-lived positron emitters into biomolecules are outlined as well. The search for chemical structures of high biological selectivity, which would be activated by slow neutrons, is related to the method of Neutron Capture Therapy, an interesting option in nuclear medicine. (author)

  9. Database setup insuring radiopharmaceuticals traceability

    International Nuclear Information System (INIS)

    Robert, N.; Salmon, F.; Clermont-Gallerande, H. de; Celerier, C.

    2002-01-01

    Having to organize radiopharmacy and to insure proper traceability of radiopharmaceutical medicines brings numerous problems, especially for the departments which are not assisted with global management network systems. Our work has been to find a solution enabling to use high street software to cover those needs. We have set up a PC database run by the Microsoft software ACCESS 97. Its use consists in: saving data related to generators, isotopes and kits reception and deletion, as well as the results of quality control; transferring data collected from the software that is connected to the activimeter (elutions and preparations registers, prescription book). By relating all the saved data, ACCESS enables to mix all information in order to proceed requests. At this stage, it is possible to edit all regular registers (prescription book, generator and radionuclides follow-up, blood derived medicines traceability) and to quickly retrieve patients who have received a particular radiopharmaceutical, or the radiopharmaceutical that has been given to a particular patient. This user-friendly database provides a considerable support to nuclear medicine department that don't possess any network management for their radiopharmaceutical activity. (author)

  10. Current directions in radiopharmaceutical research

    Energy Technology Data Exchange (ETDEWEB)

    Mather, S J [Department of Nuclear Medicine, St. Bartholomew` s Hospital, London (United Kingdom)

    1998-08-01

    Much of current radiopharmaceutical research is directed towards the development of receptor-binding tracers which are targeted towards biochemical processes. These may be extra or intracellular in nature and hold promise for an imaging approach to tissue characterisation in-vivo. Many of these products are based on proteins which range in size from large monoclonal antibodies to small neuropeptides and share a radiolabelling chemistry based on the use of bifunctional chelating agents. Although developed initially for use with indium-111, considerations of cost and isotope availability have continued to direct the efforts of many researchers towards the use of technetium-99m. While polypeptide-based radiopharmaceuticals may be useful for imaging peripheral cell-surface receptors, access to sites of interest within the cell, or in the brain, requires the development of small lipophilic molecules with retained ability to interact with intracellular targets. The design and synthesis of these compounds presents a particular challenge to the radiopharmaceutical chemist which is being met through either a pendant or integrated approach to the use of technetium coordination with particular emphasis on technetium (v) cores. Progress continues to be made in the application of targeted radionuclide therapy particularly in the development of radiopharmaceuticals for the treatment of malignant bone disease. methods for labelling antibodies with a great variety of cytotoxic radionuclides have now been refined and their use for radioimmunotherapy in the treatment of haematological malignancies shows great promise. The major medical areas for application of these new radiopharmaceuticals will be in oncology, neurology and inflammation but the increasingly difficult regulatory climate in which drug development and health-care now operate will make it essential for researchers to direct their products toward specific clinical problems as well as biological targets. (author) 36 refs

  11. Radiopharmaceuticals for diagnosis. Final report

    Energy Technology Data Exchange (ETDEWEB)

    1994-03-01

    In the period 1969-1986, this project was directed to the evolution of target-specific labeled chemicals useful for nuclear medical imaging, especially radioactive indicators suited to tracing adrenal functions and localizing tumors in the neuroendocrine system. Since 1986, this project research has focused on the chemistry of positron emission tomography (PET) ligands. This project has involved the evaluation of methods for radiochemical syntheses with fluorine-18, as well as the development and preliminary evaluation of new radiopharmaceuticals for positron emission tomography. In the radiochemistry area, the ability to predict fluorine-18 labeling yields for aromatic substitution reactions through the use of carbon-13 NMR analysis was studied. Radiochemical yields can be predicted for some structurally analogous aromatic compounds, but this correlation could not be generally applied to aromatic substrates for this reaction, particularly with changes in ring substituents or leaving groups. Importantly, certain aryl ring substituents, particularly methyl groups, appeared to have a negative effect on fluorination reactions. These observations are important in the future design of syntheses of complicated organic radiopharmaceuticals. In the radiopharmaceutical area, this project has supported the development of a new class of radiopharmaceuticals based on the monoamine vesicular uptake systems. The new radioligands, based on the tetrabenazine structure, offer a new approach to the quantification of monoaminergic neurons in the brain. Preliminary primate imaging studies support further development of these radioligands for PET studies in humans. If successful, such radiopharmaceuticals will find application in studies of the causes and treatment of neurodegenerative disorders such as Parkinson`s disease.

  12. Current directions in radiopharmaceutical research

    International Nuclear Information System (INIS)

    Mather, S.J.

    1998-01-01

    Much of current radiopharmaceutical research is directed towards the development of receptor-binding tracers which are targeted towards biochemical processes. These may be extra or intracellular in nature and hold promise for an imaging approach to tissue characterisation in-vivo. Many of these products are based on proteins which range in size from large monoclonal antibodies to small neuropeptides and share a radiolabelling chemistry based on the use of bifunctional chelating agents. Although developed initially for use with indium-111, considerations of cost and isotope availability have continued to direct the efforts of many researchers towards the use of technetium-99m. While polypeptide-based radiopharmaceuticals may be useful for imaging peripheral cell-surface receptors, access to sites of interest within the cell, or in the brain, requires the development of small lipophilic molecules with retained ability to interact with intracellular targets. The design and synthesis of these compounds presents a particular challenge to the radiopharmaceutical chemist which is being met through either a pendant or integrated approach to the use of technetium coordination with particular emphasis on technetium (v) cores. Progress continues to be made in the application of targeted radionuclide therapy particularly in the development of radiopharmaceuticals for the treatment of malignant bone disease. methods for labelling antibodies with a great variety of cytotoxic radionuclides have now been refined and their use for radioimmunotherapy in the treatment of haematological malignancies shows great promise. The major medical areas for application of these new radiopharmaceuticals will be in oncology, neurology and inflammation but the increasingly difficult regulatory climate in which drug development and health-care now operate will make it essential for researchers to direct their products toward specific clinical problems as well as biological targets. (author)

  13. Radiopharmaceutical research: trends and novel concepts

    International Nuclear Information System (INIS)

    Wuest, F.

    2005-01-01

    The efficiency of nuclear medicine in diagnosis, therapy and medicinal research strongly depends on the progress to develop novel suitable radiopharmaceuticals. The selection, preparation, and preclinical evaluation of new radiopharmaceuticals is addressed by the field of radiopharmaceutical chemistry. The rapid developments in the field of biotechnology in the post-genome era combined with the recent advances in the instrumentation of SPECT and PET have directed radiopharmaceutical research into a complex chemical science. Current radiopharmaceutical research comprises novel developments of coordination chemistry with [ 99m Tc]technetium pharmaceuticals, the development of non-standard PET radionuclides and the synthesis of 11 C- and 18 F-labelled radiopharmaceuticals at high specific radioactivity. Further developments deal with an increasing alignment to radiotherapeutics and the implementation of PET into the process of drug development and evaluation. (orig.)

  14. Radiation dose estimates for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Stabin, M.G.; Stubbs, J.B.; Toohey, R.E.

    1996-04-01

    Tables of radiation dose estimates based on the Cristy-Eckerman adult male phantom are provided for a number of radiopharmaceuticals commonly used in nuclear medicine. Radiation dose estimates are listed for all major source organs, and several other organs of interest. The dose estimates were calculated using the MIRD Technique as implemented in the MIRDOSE3 computer code, developed by the Oak Ridge Institute for Science and Education, Radiation Internal Dose Information Center. In this code, residence times for source organs are used with decay data from the MIRD Radionuclide Data and Decay Schemes to produce estimates of radiation dose to organs of standardized phantoms representing individuals of different ages. The adult male phantom of the Cristy-Eckerman phantom series is different from the MIRD 5, or Reference Man phantom in several aspects, the most important of which is the difference in the masses and absorbed fractions for the active (red) marrow. The absorbed fractions for flow energy photons striking the marrow are also different. Other minor differences exist, but are not likely to significantly affect dose estimates calculated with the two phantoms. Assumptions which support each of the dose estimates appears at the bottom of the table of estimates for a given radiopharmaceutical. In most cases, the model kinetics or organ residence times are explicitly given. The results presented here can easily be extended to include other radiopharmaceuticals or phantoms

  15. Part I: $\\beta$-delayed fission, laser spectroscopy and shape-coexistence studies with astatine beams; Part II: Delineating the island of deformation in the light gold isotopes by means of laser spectroscopy

    CERN Document Server

    Andreyev, Andrei

    2013-01-01

    Part I: $\\beta$-delayed fission, laser spectroscopy and shape-coexistence studies with astatine beams; Part II: Delineating the island of deformation in the light gold isotopes by means of laser spectroscopy

  16. In vitro evaluation of the astatinated chimeric monoclonal antibody U36, a potential candidate for treatment of head and neck squamous cell carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Nestor, M.; Anniko, M. [Uppsala University, Unit of Otolaryngology and Head and Neck Surgery, Department of Surgical Sciences, Uppsala (Sweden); Persson, M. [Uppsala University, Unit of Urology, Department of Surgical Sciences, Uppsala (Sweden); Uppsala University, Unit of Biomedical Radiation Science, Department of Oncology, Radiology and Clinical Immunology, Uppsala (Sweden); Dongen, G.A.M.S. van [Vrije Universiteit Medical Center, Department of Otolaryngology/Head and Neck Surgery, Amsterdam (Netherlands); Jensen, H.J. [Righshospitalet, PET and Cyclotron Unit, Department of Clinical Physiology and Nuclear Medicine, Copenhagen (Denmark); Lundqvist, H.; Tolmachev, V. [Uppsala University, Unit of Biomedical Radiation Science, Department of Oncology, Radiology and Clinical Immunology, Uppsala (Sweden)

    2005-11-01

    The purpose of this study was to analyse the properties of the astatinated chimeric MAb (cMAb) U36 as a conjugate to selectively target and eradicate head and neck squamous cell carcinoma (HNSCC). cMAb U36 was labelled with {sup 211}At via the linker N-succinimidyl 4-(trimethylstannyl)benzoate (SPMB). The quality of the conjugate was extensively evaluated for binding and internalisation capacity, and compared with {sup 125}I-SPMB-cMAb U36. The cellular toxicity of the astatinated conjugate was assessed in two types of in vitro growth assay and compared with {sup 131}I-labelled cMAb U36 (directly labelled). Comparisons between {sup 211}At-cMAb U36 and {sup 125}I-cMAb U36 demonstrated an optimal functional capacity of the labelled products. Immunoreactivity and affinity assays showed high immunoreactive fractions (>93%), and an affinity in good agreement between the astatinated and iodinated antibodies. For both conjugates, specific binding to HNSCC cells could be demonstrated, as well as some internalisation. Retention of the astatinated conjugate was just slightly lower than for the iodinated conjugate and still reasonable for therapeutic use (31{+-}2% vs 42.6{+-}1.0% at 22 h), demonstrating no adverse effects from astatination of the antibody. Studies on cellular toxicity demonstrated a dose-dependent and antigen-specific cellular toxicity for {sup 211}At-cMAb U36, with about 10% cell survival at 50 decays per cell. The {sup 131}I-labelled conjugate was not as efficient, with a surviving cell fraction of about 50% at 55 decays per cell. (orig.)

  17. In vitro evaluation of the astatinated chimeric monoclonal antibody U36, a potential candidate for treatment of head and neck squamous cell carcinoma

    International Nuclear Information System (INIS)

    Nestor, M.; Anniko, M.; Persson, M.; Dongen, G.A.M.S. van; Jensen, H.J.; Lundqvist, H.; Tolmachev, V.

    2005-01-01

    The purpose of this study was to analyse the properties of the astatinated chimeric MAb (cMAb) U36 as a conjugate to selectively target and eradicate head and neck squamous cell carcinoma (HNSCC). cMAb U36 was labelled with 211 At via the linker N-succinimidyl 4-(trimethylstannyl)benzoate (SPMB). The quality of the conjugate was extensively evaluated for binding and internalisation capacity, and compared with 125 I-SPMB-cMAb U36. The cellular toxicity of the astatinated conjugate was assessed in two types of in vitro growth assay and compared with 131 I-labelled cMAb U36 (directly labelled). Comparisons between 211 At-cMAb U36 and 125 I-cMAb U36 demonstrated an optimal functional capacity of the labelled products. Immunoreactivity and affinity assays showed high immunoreactive fractions (>93%), and an affinity in good agreement between the astatinated and iodinated antibodies. For both conjugates, specific binding to HNSCC cells could be demonstrated, as well as some internalisation. Retention of the astatinated conjugate was just slightly lower than for the iodinated conjugate and still reasonable for therapeutic use (31±2% vs 42.6±1.0% at 22 h), demonstrating no adverse effects from astatination of the antibody. Studies on cellular toxicity demonstrated a dose-dependent and antigen-specific cellular toxicity for 211 At-cMAb U36, with about 10% cell survival at 50 decays per cell. The 131 I-labelled conjugate was not as efficient, with a surviving cell fraction of about 50% at 55 decays per cell. (orig.)

  18. Development of European regulations on radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1990-01-01

    Separate regulatory systems are being developed on the use of radiopharmaceuticals including radiation protection of patients and personnel and on the quality including safety and efficacy of radiopharmaceuticals. Radiation protection legislation has been introduced in most western European Economic Community (EEC). Within the drug field radiopharmaceuticals have been excepted up till now. However, new EEC directive on radiopharmaceuticals will soon come into force. The work done on the preparation of regulations and guidelines will be discussed. This discussion will focus on the problems faced when radiation protection aspects shall be balanced to traditional requirements of pharmaceutical aspects

  19. Development of radiopharmaceutical for radiosinovectomy

    International Nuclear Information System (INIS)

    Couto, Renata Martinussi

    2009-01-01

    Radiopharmaceuticals prepared with different radionuclides have been used in diagnostic and therapeutic procedures in Nuclear Medicine. The interest in radionuclidic therapy has been increased in last years, with the introduction of new radiopharmaceuticals applied in the destruction of specific cells or to prevent its undesired proliferation. Radiosinovectomy (RSV) is a therapeutic modality that uses radiopharmaceuticals administered in the intra-articular cavity and represents an alternative to the treatment of different arthropaties and, in particular, the arthropaties derived from rheumatoid arthritis and haemophilic. The objective of the present work was to study the labeling of compounds with 90 Y and 177 Lu in order to improve the production conditions and quality control procedures, study the stability of the labeled compounds and preliminary biodistribution studies of the radiopharmaceuticals with potential for RSV applications. The study of the production of 90 Y citrate colloid ( 90 Y-Cit) was based in a labeling procedure using 90 Y Cl 3 solution (37 - 54 MBq) that was previously dried, followed by the addition of yttrium nitrate and sodium citrate in p H 7 at 37 deg C for 30 minutes. The production of hydroxyapatite (HA) labeled with 90 Y was based in a labeling procedure using mono hydrated citric acid, yttrium nitrate and 90 Y Cl 3 solution (37 - 370 MBq). The reaction mixture was incubated for 30 minutes at room temperature and the HA was introduced in aqueous medium and the reaction proceed for 30 minutes under strong stirring. 177 Lu-HA was produced using 177 Lu Cl 3 solution (296 MBq), in presence of lutetium oxide in NaCl medium, p H 7, under continuous stirring for 30 minutes at room temperature. Several reaction parameters were studied for the three radiopharmaceuticals. Labeling yield was determined after particles were centrifuged and washed with NaCl 0,9%. Radiochemical purity was determined by ascending chromatography using different

  20. Development and therapeutic application of internally emitting radiopharmaceuticals

    International Nuclear Information System (INIS)

    Adelstein, S.J.; Bloomer, W.D.

    1980-01-01

    This project is concerned with developing the potential of alpha-emitting radionuclides as agents for radiotherapy. Among the available α-emitters, astatine-211 appears most promising for testing the efficacy of α-emitters for therapeutic applications because: (1) it has some chemical similarities to iodine, an element that can readily be incorporated into numerous proteins and peptides; (2) it has a half life that is long enough to permit chemical manipulation yet short enough to minimize destruction of healthy cells; and (3) α-emission is associated with 100% of its decays. If appropriate biological carriers can be labeled with an alpha emitter such as 211 At, they could be of great utility in several areas of therapeutic medicine where elimination of specific cell populations is desired. While previous attempts to astatinate proteins using standard iodination techniques have been unsuccessful, effective labeling of proteins with astatine by first synthesizing an aryl astatide and then coupling this compound to the protein via an acylation has been achieved. Undergoing current investigation are several different aryl astatide-followed-by-acylation approaches including an astatinated Bolton-Hunter type reagent using concanavalin A (ConA) and melanocyte stimulating hormone (MSH) as model compounds

  1. Quality control in 99m technetium radiopharmaceuticals

    International Nuclear Information System (INIS)

    Leon Cabana, Alba

    1994-01-01

    This work means about the quality control in Tc radiopharmaceuticals preparation at hospitalary levels. Several steps must be used in a Nuclear Medicine Laboratory, such as proceeding,radiopharmaceuticals kits preparation, and dispensation materials,glasses,stopper,physical aspects,identification,ph control,storage,and reactif kits

  2. Physical and Chemical Aspects of PET Radiopharmaceuticals

    International Nuclear Information System (INIS)

    2004-09-01

    On the Workshop 23 contributions were presented. This proceedings includes 21 presentations delivered at the workshop. The topics discussed included: Cyclotron and Target Constructions; Target Chemistry; Radiopharmaceuticals Synthesis; Quality Control of Radiopharmaceuticals; GLP-GMP Design; PET Imaging. Each presentation has been indexed separately

  3. Studies of quality control procedures for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Zivanovic, M.; Trott, N.G.

    1983-01-01

    In this paper, a short description is given of a radiopharmaceutical preparation suite set up at the Royal Marsden Hospital and an account is presented of methods used for quality control of radiopharmaceuticals and of the results obtained over a period of about two and a half years

  4. Radiopharmaceuticals for diagnosis of ischemic heart disease

    Energy Technology Data Exchange (ETDEWEB)

    Komarek, P; Chalabala, M [Institut pro Dalsi Vzdelavani Lekaru a Farmaceutu, Prague (Czechoslovakia)

    1982-01-01

    Radiopharmaceuticals used for diagnosing ischemic heart disease in the experimental and clinical practice are reviewed. The mechanism of their retention by the heart muscle is briefly described. The respective radiopharmaceuticals are divided into preparations imaging disorders in the blood supply of the cardiac muscle, diagnosing the myocardial infarction, and evaluating the contractility of the heart.

  5. Chirality plays important roles in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Shen Yumei

    2006-01-01

    The paper introduces the basic concept of chirality, target specific selectivity and their relationship in radiopharmaceuticals. If the ligands labeled by radionuclides have chiral center, the enantiomers must be separated, or the target specific selectivity will not be good. Chirality is one of the most important factors which must be considered in the study of the structure-activity relationship of radiopharmaceuticals. (authors)

  6. Preparation and control of radiopharmaceuticals in hospitals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1979-01-01

    This guidebook covers the work commonly organized as part of the work in the hospital. It does not cover the manufacture of radiopharmaceuticals on an industrial scale. The work is characterized by the small scale on which manufacture and preparation of radiopharmaceuticals take place

  7. Radiopharmaceuticals. 40 years is nothing

    International Nuclear Information System (INIS)

    Hager, Alfredo A.

    2006-01-01

    The nuclear medicine is today a medical speciality recognized and practised in the whole world. The birth was in the middle of the 20th century in the use of molecules or drugs marked with a radionuclide (radiopharmaceutical), for the diagnostic studies in vivo or in vitro, to obtain a therapeutic effect. Early in the decade of 70, its development and evolution was accentuated thanks to electronics, the contribution of new instruments for detection of diagnosis by images (gamma camera) and to the emergence of new radionuclide (in particular, 99m Tc). (author) [es

  8. Clean room installations in a radiopharmaceutical facility

    International Nuclear Information System (INIS)

    2000-01-01

    The standards of radiopharmaceuticals on the facility, working environment and preparation control strategy are yet to be generated. In general, radiopharmaceuticals have short half-lives and emit gamma radiation. Due to its unique characteristics, its preparation has to be made in the fume hood and hot cell to avoid radiation exposure to workers. Considering radiation protection, the working environment has to be maintained under negative pressure so that dispersion of radiopharmaceuticals should be avoided. On the contrary, a positively pressurized working environment gives clean atmosphere and prevents contamination with harmful microorganisms during preparation. Hence, it is required to harmonize for mentioned contradictory conditions in preparation of radiopharmaceuticals for the safety of workers and its quality assurance as well. Therefore, it is reasonable that good manufacturing practice for radiopharmaceutical production facility should be constituted according to the standards for production of biological agents accompanied with a radiation shielding

  9. Radiopharmaceuticals production activities in Egypt

    International Nuclear Information System (INIS)

    Raieh, M.

    1998-01-01

    Applications of radiopharmaceuticals and labelled compounds in the field of nuclear medicine in Egypt have increased so rapidly in the last few years. At present, a large number of hospitals are utilizing these radioisotopic techniques for both diagnosis and treatment. The following production activities are taking place in the Egyptian Radioisotope Production laboratories. By utilizing the research reactor a large number of radioisotopes which find wide applications in nuclear medicine were produced, such as iodine-131, phosphorus-32, sodium-24, potassium-42 and molybdenum-99 / technetium-99m generators. Gallium-67, indium-111 and iodine-123 will be produced locally after installation of the cyclotron at the end of 1998. A large number of Tc-99m based kits for diagnostic medical applications have been produced. Also, many radiopharmaceuticals labelled with iodine-131 were produced. The radioisotope production laboratory is able to supply many hospitals with the radioimmunoassay kits of the thyroid related hormones (T4, T3 and TSH). Research and development activities are taking place in the field of monoclonal antibodies and tumor markers with special consideration of AFP, CEA, PSA and βhCG. (author)

  10. Fourth international radiopharmaceutical dosimetry symposium

    International Nuclear Information System (INIS)

    Schlafke-Stelson, A.T.; Watson, E.E.

    1986-04-01

    The focus of the Fourth International Radiopharmaceutical Dosimetry Symposium was to explore the impact of current developments in nuclear medicine on absorbed dose calculations. This book contains the proceedings of the meeting including the edited discussion that followed the presentations. Topics that were addressed included the dosimetry associated with radiolabeled monoclonal antibodies and blood elements, ultrashort-lived radionuclides, and positron emitters. Some specific areas of discussion were variations in absorbed dose as a result of alterations in the kinetics, the influence of radioactive contaminants on dose, dose in children and in the fetus, available instrumentation and techniques for collecting the kinetic data needed for dose calculation, dosimetry requirements for the review and approval of new radiopharmaceuticals, and a comparison of the effect on the thyroid of internal versus external irradiation. New models for the urinary blader, skeleton including the active marrow, and the blood were presented. Several papers dealt with the validity of traditional ''average-organ'' dose estimates to express the dose from particulate radiation that has a short range in tissue. These problems are particularly important in the use of monoclonal antibodies and agents used to measure intracellular functions. These proceedings have been published to provide a resource volume for anyone interested in the calculation of absorbed radiation dose

  11. Radiopharmaceuticals used in nuclear cardiology

    International Nuclear Information System (INIS)

    Costa, H.

    1985-01-01

    During the last years, since short physical mean life radionuclides have started to be used, radionuclide scanning has been experienced with remarkable culmination. There are detector devices, which jointly with computation equipments, allow to obtain multiple images per second as properly rapid gammagraphic series, in order to obtain whole hemodynamic data or to generate functional images no representing an anatomical structure but reporting about cardiac dynamics at regional level. In these techniques, employed in Nuclear Cardiology, the following radionuclides and radiopharmaceuticals are used: radiolabeled albumin 99m Tc red blood cells, 113m In-transferrin, very short physical mean life radionuclides, such as 195m Au, 178 Ta, 191 Ir. In addition, 113 Xe for coronary flow measurements; radiolabeled microspheres and macroparticles for angiogammagraphy; 129 Cs, 43 K, 81 Rb, 82 Rb and 201 Ti, the most largerly used, for myocardial gammagraphy. It is pointed out that fatty acids are the newest, basically if are radioiodate, and some 99m Tc labeled long chain hydrocarbons. It is expressed that 99m Tc-Sn-pyrophosphate has been used for myocardial infarction. Working on the development of new radiopharmaceuticals, basically fatty acids and 99m Tc chelating agents, for the improvement of these techniques is carried out. (author)

  12. The development of new radiopharmaceuticals

    International Nuclear Information System (INIS)

    Britton, K.E.

    1990-01-01

    The development of new radiopharmaceuticals is the basis of the continuing growth of nuclear medicine. Chemical interactions of electron clouds in their three-dimensional conformations bring together, in the process of molecular recognition, the reaction of antibody and antigen, receptor and ligand, enzyme and substrate, hormone and response site. This convergence enables the computer design of molecules such as ligands to fit computer-displayed conformational models showing active centres, positive and negative charges and other interactions. Indeed, given a particular molecule, a complementary binding structure can be devised. The hybridoma approach to monoclonal antibody production is being superceded by the bacterial bioengineer. The gene for the hypervariable region from the spleen cells of immunized mouse can be coupled with the myeloma gene. The polymerase chain reaction can duplicate the DNA a million times over in 20 min and the result transfected into a bacterial plasmid to produce the antibody. These scientific problems are soluble in principle and are being solved. However, so much damage to this developing biological field is being done by regulatory authorities that one must ask who should or can regulate the regulators. The problems have to be overcome in order to provide the new radiopharmaceuticals that are the food and wine of nuclear medicine. (orig.)

  13. Production of radiopharmaceuticals by cyclotrons

    International Nuclear Information System (INIS)

    Schmitz, F.; Van Naemen, J.; Monclus, M.; Van Gansbeke, B.; Kadiata, M.; Ekelmans, D.; Moray, M.; Penninckx, R.; Goldman, S.

    2004-01-01

    Companies specialized in the development and installation of accelerator-based systems dedicated to the medical applications brought on the market cyclotrons well fitted to the requests of the industrial community or universities and so covering every segment of the market. These machines are fully automatic, and need reduced maintenance; they are highly specialized for defined tasks. They can produce high beam intensity and realize dual beam irradiation. Also the prices are reducing considerably. The targets and the automatic system follow the same trend. Unfortunately, the flexibility of these devices for new area of research and development has been dramatically reduced. The growing number of PET cameras has increased the popularity of PET tracers used for nuclear imaging. Consequently, there is a growing demand for these radiopharmaceuticals compounds labeled with short-lived radioisotopes for clinical applications. From a research and development tool in the eighties, PET has now grown up to a clinical tool. Moreover, depending of the social welfare, reimbursement of some PET examinations is granted, which accelerates the trend for an extended use of PET tracers. Regulatory affairs try to establish and standardize the control on these radiopharmaceutical compounds produced in a growing number of local radio pharmacies owning a baby cyclotron. On the other hand, the attention of equipment suppliers was brought in the setting up of a total quality control follow up. These efforts were successively achieved by getting for instance the ISO 9001 certificate

  14. Radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1971-07-01

    Radioisotopes are being used to an ever-increasing extent in medicine for diagnosis and therapy. In this contributed article, Walter Wolf, of the School of Pharmacy, University of Southern California, Los Angeles, USA, and Alexandru T. Balaban, formerly a senior research officer in the IAEA Division of Research and Laboratories and now working in the chemistry section of the Institute of Atomic Physics, Bucharest, Romania, discuss some applications, and consider possible developments. (author)

  15. Radiopharmaceuticals drug interactions: a critical review

    International Nuclear Information System (INIS)

    Santos-Oliveira, Ralph; Smith, Sheila W.; Carneiro-Leao, Ana Maria A.

    2008-01-01

    Radiopharmaceuticals play a critical role in modern medicine primarily for diagnostic purposes, but also for monitoring disease progression and response to treatment. As the use of image has been increased, so has the use of prescription medications. These trends increase the risk of interactions between medications and radiopharmaceuticals. These interactions which have an impact on image by competing with the radiopharmaceutical for binding sites for example can lead to false negative results. Drugs that accelerate the metabolism of the radiopharmaceutical can have a positive impact (i.e. speeding its clearance) or, if repeating image is needed, a negative impact. In some cases, for example in cardiac image among patients taking doxirubacin, these interactions may have a therapeutic benefit. The incidence of drug-radiopharmaceuticals adverse reactions is unknown, since they may not be reported or even recognized. Here, we compiled the medical literature, using the criteria of a systematic review established by the Cochrane Collaboration, on pharmaceutical-drug interactions to provide a summary of documented interactions by organ system and radiopharmaceuticals. The purpose is to provide a reference on drug interactions that could inform the nuclear medicine staff in their daily routine. Efforts to increase adverse event reporting, and ideally consolidate reports worldwide, can provide a critically needed resource for prevention of drug-radiopharmaceuticals interactions. (author)

  16. High-efficiency astatination of antibodies using N-iodosuccinimide as the oxidising agent in labelling of N-succinimidyl 3-(trimethylstannyl)benzoate

    International Nuclear Information System (INIS)

    Lindegren, S.; Andersson, H.; Baeck, T.; Jacobsson, L.; Karlsson, B.; Skarnemark, G.

    2001-01-01

    Monoclonal antibodies C215, reactive with colorectal carcinomas, and MOv18, reactive with most of the ovarian carcinomas, were radiohalogenated with [ 211 At]astatine. The radiohalogen was conjugate coupled to antibodies via the intermediate labelling reagent N-succinimidyl-3-(trimethylstannyl)benzoate (m-MeATE) in a two-step, single-pot reaction. Optimisation of the labelling of the reagent was achieved using N-iodosuccinimide, NIS, as the oxidising agent. The yields ranged from 69-95% in the labelling of 0.1-1.0 nmole of the m-MeATE precursor. Subsequent conjugation to antibodies resulted in yields of 58±7%. In vitro binding to tumour cells showed that the immunoreactivity of both antibodies was retained after astatine labelling

  17. An all-solid state laser system for the laser ion source RILIS and in-source laser spectroscopy of astatine at ISOLDE, CERN

    CERN Document Server

    Rothe, Sebastian; Nörtershäuser, W

    This doctoral thesis describes the extension of the resonance ionization laser ion source RILIS at ISOLDE, CERN, by the addition of an all-solid state tuneable titanium: sapphire (Ti:Sa) laser system to complement the well-established system of dye lasers. Synchronous operation of the so called Dual RILIS system of Ti:Sa and dye lasers was investigated and the potential for increased ion beam intensity, reliability, and reduced setup time has been demonstrated. In-source resonance ionization spectroscopy was performed at ISOLDE, CERN, and at ISAC, TRIUMF, radioactive ion beam facilities to develop an efficient and selective three-colour ionization scheme for the purely radioactive element astatine. A LabVIEW based monitoring, control and measurement system was conceived which enabled, in conjunction with Dual RILIS operation, the spectroscopy of high lying Rydberg states, from which the ionization potential of the astatine atom was determined for the first time experimentally.

  18. An all-solid state laser system for the laser ion sources RILIS and in-source laser spectroscopy of astatine at ISOLDE/CERN

    International Nuclear Information System (INIS)

    Rothe, Sebastian

    2012-01-01

    This doctoral thesis describes the extension of the resonance ionization laser ion source RILIS at CERN/ISOLDE by the addition of an all-solid state tunable titanium:sapphire (Ti:Sa) laser system to complement the well-established system of dye lasers. Synchronous operation of the so called Dual RILIS system of Ti:Sa and dye lasers was investigated and the potential for increased ion beam intensity, reliability, and reduced setup time has been demonstrated. In-source resonance ionization spectroscopy was performed at ISOLDE/CERN and at ISAC/TRIUMF radioactive ion beam facilities to develop an efficient and selective three-colour ionization scheme for the purely radioactive element astatine. A LabVIEW based monitoring, control and measurement system was conceived which enabled, in conjunction with Dual RILIS operation, the spectroscopy of high lying Rydberg states, from which the ionization potential of the astatine atom was determined for the first time experimentally.

  19. An all-solid state laser system for the laser ion sources RILIS and in-source laser spectroscopy of astatine at ISOLDE/CERN

    Energy Technology Data Exchange (ETDEWEB)

    Rothe, Sebastian

    2012-09-24

    This doctoral thesis describes the extension of the resonance ionization laser ion source RILIS at CERN/ISOLDE by the addition of an all-solid state tunable titanium:sapphire (Ti:Sa) laser system to complement the well-established system of dye lasers. Synchronous operation of the so called Dual RILIS system of Ti:Sa and dye lasers was investigated and the potential for increased ion beam intensity, reliability, and reduced setup time has been demonstrated. In-source resonance ionization spectroscopy was performed at ISOLDE/CERN and at ISAC/TRIUMF radioactive ion beam facilities to develop an efficient and selective three-colour ionization scheme for the purely radioactive element astatine. A LabVIEW based monitoring, control and measurement system was conceived which enabled, in conjunction with Dual RILIS operation, the spectroscopy of high lying Rydberg states, from which the ionization potential of the astatine atom was determined for the first time experimentally.

  20. Uncertainty sources in radiopharmaceuticals clinical studies

    International Nuclear Information System (INIS)

    Degenhardt, Aemilie Louize; Oliveira, Silvia Maria Velasques de

    2014-01-01

    The radiopharmaceuticals should be approved for consumption by evaluating their quality, safety and efficacy. Clinical studies are designed to verify the pharmacodynamics, pharmacological and clinical effects in humans and are required for assuring safety and efficacy. The Bayesian analysis has been used for clinical studies effectiveness evaluation. This work aims to identify uncertainties associated with the process of production of the radionuclide and radiopharmaceutical labelling as well as the radiopharmaceutical administration and scintigraphy images acquisition and processing. For the development of clinical studies in the country, the metrological chain shall assure the traceability of the surveys performed in all phases. (author)

  1. Positron emitting radiopharmaceuticals for cancer

    International Nuclear Information System (INIS)

    Krohn, K.A.; Graham, M.M.

    1989-01-01

    Cancer is principally a biochemical disease involving abnormal enzymology, gene expression and/or membrane composition. Cytotoxic chemical treatments, including radiation products, are important in controlling cancer. It therefore follows that imaging of the biochemical differences between tumor and normal tissues should lead to more effective therapy. Metabolic imaging should identify the best new treatment protocol for an individual patient and may identify specific causes of resistance to therapy. Methods have been developed for imaging the metabolism of energy substrates (glucose and O 2 ), and DNA precursors (thymidine) and for specifically identifying hormone-dependent tumors (estrogen or testosterone) and hypoxic tissues (bioreductive alkylators). Together these new radiopharmaceuticals are leading to better cancer therapy, not just improving diagnosis, but more by following the different responses of tumor and surrounding normal tissues to cytotoxic therapy

  2. Radiopharmaceutical agents for skeletal scanning

    International Nuclear Information System (INIS)

    Jansen, S.E.; Van Aswegen, A.; Loetter, M.G.; Minnaar, P.C.; Otto, A.C.; Goedhals, L.; Dedekind, P.S.

    1987-01-01

    The quality of bone scan images obtained with a locally produced and with an imported radiopharmaceutical bone agent, methylene diphosphonate (MDP), was compared visually. Standard skeletal imaging was carried out on 10 patients using both agents, with a period of 2 to 7 days between studies with alternate agents. Equal amounts of activity were administered for both agents. All images were acquired on Polaroid film for subsequent evaluation. The acquisition time for standard amount of counts per study was recorded. Three physicians with applicable experience evaluated image quality (on a 4 point scale) and detectability of metastasis (on a 3 point scale). There was no statistically significant difference (p 0,05) between the two agents by paired t-test of Hotelling's T 2 analysis. It is concluded that the imaging properties of the locally produced and the imported MDP are similar

  3. Characterization of aerosols containing radiopharmaceuticals

    International Nuclear Information System (INIS)

    Cunha, Kenya Dias da; Santos, Maristela Souza

    2008-01-01

    The objective of this study is to present the main lines of action of the Laboratorio de Caracterizacao de Aerossois (LCA /IRD) in the study of aerosols, the techniques available and the capability of these techniques as a tool in the biokinetics behavior study of radiopharmaceuticals and evaluating the particle exposed individuals containing these molecules. The LCA provides the following analytical techniques: spectrometry alpha, gamma and alpha counting and gross beta; PIXE (Particle Induced X rays Emission) and mass spectrometry-based flight time measurement of molecular ions ( 252 Cf-PDMS - 252 Cf-Plasma Desorption Mass Spectrometry). This technique is used to identify compounds mass to 10 000 a.m.u. The combination of these techniques has been applied to the study in vitro of the toxicology of the metals and radionuclides both in the respiratory tract as in the gastrointestinal

  4. Radiobiological Effects of Alpha-Particles from Astatine-211: From DNA Damage to Cell Death

    Energy Technology Data Exchange (ETDEWEB)

    Claesson, Kristina

    2011-05-15

    In recent years, the use of high linear energy transfer (LET) radiation for radiotherapeutic applications has gained increased interest. Astatine-211 (211At) is an alpha-particle emitting radionuclide, promising for targeted radioimmunotherapy of isolated tumor cells and microscopic clusters. To improve development of safe radiotherapy using 211At it is important to increase our knowledge of the radiobiological effects in cells. During radiotherapy, both tumors and adjacent normal tissue will be irradiated and therefore, it is of importance to understand differences in the radio response between proliferating and resting cells. The aim of this thesis was to investigate effects in fibroblasts with different proliferation status after irradiation with alpha-particles from 211At or X-rays, from inflicted DNA damage, to cellular responses and biological consequences. Throughout this work, irradiation was performed with alpha-particles from 211A or X-rays. The induction and repair of double-strand breaks (DSBs) in human normal fibroblasts were investigated using pulsed-field gel electrophoresis and fragment analysis. The relative biological effectiveness (RBE) of 211At for DSB induction varied between 1.4 and 3.1. A small increase of DSBs was observed in cycling cells compared to stationary cells. The repair kinetics was slower after 211At and more residual damage was found after 24 h. Comparison between cells with different proliferation status showed that the repair was inefficient in cycling cells with more residual damage, regardless of radiation quality. Activation of cell cycle arrests was investigated using immunofluorescent labeling of the checkpoint kinase Chk2 and by measuring cell cycle distributions with flow cytometry analysis. After alpha-particle irradiation, the average number of Chk2-foci was larger and the cells had a more affected cell cycle progression for several weeks compared with X-irradiated cells, indicating a more powerful arrest after 211At

  5. Computational system for activity calculation of radiopharmaceuticals

    African Journals Online (AJOL)

    STORAGESEVER

    2008-12-29

    Dec 29, 2008 ... 2National Nuclear Energy Commission, Brazil. Accepted 24 October ... radiopharmaceuticals in use around the world with ... ment with a very important aspects: no profits ends. The tool ... The software interface is showed in ...

  6. Radiopharmaceutical chemistry for positron emission tomography

    NARCIS (Netherlands)

    Elsinga, PH

    Radiopharmaceutical chemistry includes the selection, preparation, and preclinical evaluation of radiolabeled compounds. This paper describes selection criteria for candidates for positron emission tomography (PET) investigations. Practical aspects of nucleophilic and electrophilic

  7. Metabolic radiopharmaceutical therapy in nuclear medicine

    International Nuclear Information System (INIS)

    Reguera, L.; Lozano, M. L.; Alonso, J. C.

    2016-01-01

    In 1986 the National Board of Medical Specialties defined the specialty of nuclear medicine as a medical specialty that uses radioisotopes for prevention, diagnosis, therapy and medical research. Nowadays, treatment with radiopharmaceuticals has reached a major importance within of nuclear medicine. The ability to treat tumors with radiopharmaceutical, Radiation selective therapy has become a first line alternative. In this paper, the current situation of the different therapies that are sued in nuclear medicine, is reviewed. (Author)

  8. Radiation decomposition of technetium-99m radiopharmaceuticals

    International Nuclear Information System (INIS)

    Billinghurst, M.W.; Rempel, S.; Westendorf, B.A.

    1979-01-01

    Technetium-99m radiopharmaceuticals are shown to be subject to autoradiation-induced decomposition, which results in increasing abundance of pertechnetate in the preparation. This autodecomposition is catalyzed by the presence of oxygen, although the removal of oxygen does not prevent its occurrence. The initial appearance of pertechnetate in the radiopharmaceutical is shown to be a function of the amount of radioactivity, the quantity of stannous ion used, and the ratio of /sup 99m/Tc to total technetium in the preparation

  9. Report of the Task Force on radiopharmaceuticals

    International Nuclear Information System (INIS)

    Lacker, D.K.; Porter, B.J.; Watkins, G.

    1975-01-01

    The procedures for evaluation of IND and NDA applications were reviewed by FDA and the state members of the Task Force believe that there is significant progress being made toward expeditious handling of these items. Progress toward publication of the final rule on radiopharmaceuticals has reduced the need for state regulatory activity in investigational aspects of radiopharmaceutical research to the point that the original concept for the training is no longer valid

  10. Rational development of radiopharmaceuticals for HIV-1

    International Nuclear Information System (INIS)

    Lau, Chuen-Yen; Maldarelli, Frank; Eckelman, William C.; Neumann, Ronald D.

    2014-01-01

    The global battle against HIV-1 would benefit from a sensitive and specific radiopharmaceutical to localize HIV-infected cells. Ideally, this probe would be able to identify latently infected host cells containing replication competent HIV sequences. Clinical and research applications would include assessment of reservoirs, informing clinical management by facilitating assessment of burden of infection in different compartments, monitoring disease progression and monitoring response to therapy. A “rational” development approach could facilitate efficient identification of an appropriate targeted radiopharmaceutical. Rational development starts with understanding characteristics of the disease that can be effectively targeted and then engineering radiopharmaceuticals to hone in on an appropriate target, which in the case of HIV-1 (HIV) might be an HIV-specific product on or in the host cell, a differentially expressed gene product, an integrated DNA sequence specific enzymatic activity, part of the inflammatory response, or a combination of these. This is different from the current approach that starts with a radiopharmaceutical for a target associated with a disease, mostly from autopsy studies, without a strong rationale for the potential to impact patient care. At present, no targeted therapies are available for HIV latency, although a number of approaches are under study. Here we discuss requirements for a radiopharmaceutical useful in strategies targeting persistently infected cells. The radiopharmaceutical for HIV should be developed based on HIV biology, studied in an animal model and then in humans, and ultimately used in clinical and research settings

  11. Radiopharmaceutical development and clinical needs

    International Nuclear Information System (INIS)

    Vieira, M.R.

    1998-01-01

    The use of radionuclides for medical applications has continued to grow at a very rapid pace. The use of radiotracers for nuclear medicine imaging and for radiotherapy of cancer as well as certain benign disorders is firmly established as an important clinical modality. Over the past ten years, nuclear medicine has experienced an evolution towards functional studies and novel therapeutic approaches. New radionuclides are required for these applications. In the developmental stages, each new isotope has to go through a phase of careful scrutiny and evaluation, and practical concerns related to the cost of production and availability must be addressed. The development of 18 F-labeled radiopharmaceuticals has opened a completely new area of investigation. Research on bioconjugates (this term includes radiolabeled antibodies, peptides, receptor-specific and other bioactive molecules) has experienced rapid growth because of the promise of a number of these ''bioactive molecules'' to serve as selective carriers of radionuclides for tumor-associated and other specific antigens/receptors ''in vivo''. The new concept of nuclear medicine, particularly when applied to the field of oncology is directed towards the physiological mechanisms and the study of molecular disfunctions. The search for new radiopharmaceuticals thus aims at studying tumors at a tissue and molecular level. Examples of this new approach are scans utilizing the following substances: -guanethidine and noradrenaline analogues such as meta-iodo-benzyl-guanidine labeled with iodine-131 or iodine-123 aimed at targeting neuroendocrine cells and their secretory granules; -various monoclonal antibodies directed at different tumor types, both for diagnostic and therapeutic purposes. Radioimmunotherapy is considered particularly suited for treatment of tumors not easily amenable to surgery and for the treatment of small disseminated lesions; -somatostatin analogs tagged with indium-111 or more recently with Yttrium

  12. Monoclonal antibody hapten radiopharmaceutical delivery

    International Nuclear Information System (INIS)

    Goodwin, D.A.; McTigue, M.

    1986-01-01

    One hundred μg of monoclonal antibody (MoAb) CHA255 with a binding constant Kb of 4 x 10 9 was complexed with indium-111 labelled BLEDTA II, BLEDTA IV, benzyl EDTA, and an EDTA conjugate of Fab. The 24-h tumour and organ distribution of BALB/c mice bearing KHJJ tumours was studied for each compound alone, the antibody complex, and 3 h following a chelate chase of the antibody complex. Whole body biological half-life was measured for 7 days with and without a chelate chase for each antibody complex. The 24-h whole body counts dropped 20 to 60% and blood concentration fell over 89% within 3 h of administering the chelate chase. Theoretical equivalent human organ doses were calculated from the 24-h organ concentrations, effective half-life, and MIRD 11 S values (absorbed dose per cumulated activity). Liver and spleen were the target organs, with the dose ranging from 0.50 to 3.91 rads mCi -1 . The reduction in organ radiation dose varied up to 95% following the chelate chase. Rapid selective renal clearance of chelate labelled radiopharmaceuticals by competitive inhibition (chelate chase) of their reversible binding to monoclonal antibodies enhances tumour imaging and improves the radiation dosimetry. (author)

  13. Gallium and copper radiopharmaceutical chemistry

    International Nuclear Information System (INIS)

    Green, M.A.; John, E.K.; Barnhart, A.J.

    1990-01-01

    Several isotopes of gallium and copper exhibit nuclear properties that make them attractive for applications in nuclear medicine, most notably Ga-67, Ga-68, Cu-67 and Cu-62. Of these, gamma-emitting Ga-67 has historically found the greatest clinical use, based on the observation that tracer gallium(III) citrate rapidly produces Ga-67 transferrin upon intravenous injection and then slowly affords selective Ga-67 localization in sites of abscess and certain tumors. Copper-67 has received attention as a potential label for tissue-selective monoclonal antibodies, since its associated γ-photons can be used for external imaging and its β - -emissions could be used for radiation therapy. Positron-emitting gallium-68 and copper-62, being available from parent/daughter generator systems, have attracted interest as potential labels for radiopharmaceuticals used in positron emission tomography (PET) because they could reduce the dependence of this imaging technology on hospital-based cyclotrons. The 10 min. half-life of Cu-62 is particularly well-suited to the time frame of PET studies of tissue perfusion, an application for which Cu(II)-bis(thiosemicarbazone) derivatives appear promising. The 68 min. half-life of Ga-68 makes it appropriate for PET studies over longer imaging time spans

  14. [Nuclear cardiology with new radiopharmaceuticals].

    Science.gov (United States)

    Bunko, H

    1994-08-01

    In the field of nuclear cardiology, 99mTc labeled myocardial perfusion agents such as MIBI, Tetrofosmin and Teboroxime, 111In-antimyosin for imaging of myocardial necrosis, 123I-betamethyl-iodophenylpentadecanoic acid (BMIPP) for imaging of myocardial fatty acid metabolism and 123I-metaiodobenzylguanidine (MIBG) for imaging of myocardial adrenergic function are introduced recently in Japan. Improved image quality and simultaneous evaluation of myocardial perfusion, function and wall motion can be obtained with use of 99mTc labeled myocardial perfusion agents. 111In-antimyosin enables specific imaging of myocardial necrosis which leads to the use for wide variety of heart diseases. Discrepancy of the myocardial perfusion and metabolism in case of stunned myocardium or cardiomyopathy can be evaluated by 123I-BMIPP in conjunction with perfusion agent. Recently wide variety of diseases which may have cardiac adrenergic abnormality are targeted for 123I-MIBG imaging. These new radiopharmaceuticals are expected to be powerful tool for evaluation of the pathophysiology including severity and prognosis and evaluation of the etiology of the various heart diseases.

  15. Radiopharmaceuticals For Detection Of Inflammation And Infection

    International Nuclear Information System (INIS)

    Nurlaila, Z.

    2002-01-01

    Feeling of pain in the body could be caused by reaction of inflantation and infection as well. One of the methods could be used to detect the reaction is nuclear technique using radiopharmaceutical as radiotracer. Some radiopharmaceuticals having specific accunulation mechanism to diagnose the presence of inflamations and infections with satisfactory results. Among those radiophannaceuticals are technetium-99m-hexamethylpropileneamine-white blood cell ( 99m Tc-HMPAO-WBC), indium-111-oxine-white blood cell ( 111 In-oksin-WBC). technetium-99m-immunoglobuline G ( 99m Tc-lgG) and technetium-99m-infecton ( 99m Tc-infecton). In visualization using this method. the information of a serial previous medical treatment of the patient should be known, because cer1ain medicament, could influence the biological characteristic of radiopharmaceuticals and hence. a missed diagnosis could be resulted. This review discusses several radiopharmaceuticals for inflamation and infection, diagnoses their accumulation, mechanism in the body. Besides, the radiopharmaceuticals interaction with several drugs are also reviewed

  16. Frequency of adverse reactions to radiopharmaceuticals in Europe

    Energy Technology Data Exchange (ETDEWEB)

    Hesslewood, S.R.; Keeling, D.H. [Radiopharmacy Department, City Hospital NHS Trust, Dudley Road, Birmingham B18 7QH (United Kingdom)

    1997-09-01

    A prospective survey was performed in 17 nuclear medicine departments during 1996 in an attempt to provide reliable data on the prevalence of adverse reactions to radiopharmaceuticals. All adverse events following radiopharmaceutical administration were recorded, irrespective of the severity or likelihood of causality, and subsequently analysed using an algorithm developed by Silberstein et al., designed to establish a cause-effect relationship. A prevalence of 11 events per 10{sup 5}administrations was obtained (95% confidence limits 3.3-19.2). No serious of life-threatening events were reported. This rate is slightly higher than that obtained in a larger scale study in the United States (2.3 events per 10 {sup 5}administrations, 95% confidence limits 1.2-3.4). The difference may be due to the decision to include or exclude vasovagal events from the analysis, the way in which the algorithm was used and the comparative size and time scale of the two studies. The prevalence of adverse reactions is approximately 1000-fold than less that occurring with iodinated contrast media and drugs. (orig.). With 2 tabs.

  17. Radiopharmaceutical management in Brazil: the case of fluorodeoxyglucose production

    International Nuclear Information System (INIS)

    Pereira, Vitor da Silva

    2016-01-01

    Nowadays, the combination of fluorodeoxyglucose tracer (FDG) and PET/CT equipment is the best technological condition for medical diagnosis, allowing the generation of images that associate anatomy and metabolic functions of tissues or organs. Constitutional Amendment (CA) No 49 of 2006, relaxed the state monopoly on the production of radioactive substances, allowing private investment in radioisotope area with half-life of less than or equal to two hours, as a way to increase the supply of these materials to national health sector. In order to reflect on the Brazilian production of radiopharmaceuticals, especially FDG was performed a theoretical study with a qualitative approach, substantiated by documentary research and data collection through a questionnaire sent to the producing private companies of this radiopharmaceutical. Initially, it sought to identify in the federal level the legal and regulatory parameters for the activity; then the existing competitive environment was observed, and, finally, were prospected the business perspectives on the behavior of domestic demand of this product. The results showed the growth of production and its largest geographical distribution in the country, beyond what would be possible only considering public investment; but short of expectations surrounding the enactment of Constitutional Amendment. Private entrepreneurs believe in market growth; since, most of the population has no access to the benefits that the medical imaging diagnostic with the use of FDG may allow. It was also noted that there is a need to improve the regulatory framework in relation to licensing procedures; as well as implementation of common marketing parameters. (author)

  18. Quality controls of radiopharmaceuticals used in nuclear medicine

    International Nuclear Information System (INIS)

    Gomez de Castiglia, S.I.; Fraga de Suarez, A.H.; Mitta, A.E.A.

    1981-01-01

    Chromatographic quality controls for Tc-99m; In-113m; I-131; Tl-201 and Ga-67 radiopharmaceuticals are described. Moreover, a chromatographic system which allows to separate different radiopharmaceuticals from In-113m is pointed out. (author) [es

  19. Radiopharmaceutical development of radiolabelled peptides

    Energy Technology Data Exchange (ETDEWEB)

    Fani, Melpomeni; Maecke, Helmut R. [University Hospital Freiburg, Department of Nuclear Medicine, Freiburg (Germany)

    2012-02-15

    Receptor targeting with radiolabelled peptides has become very important in nuclear medicine and oncology in the past few years. The overexpression of many peptide receptors in numerous cancers, compared to their relatively low density in physiological organs, represents the molecular basis for in vivo imaging and targeted radionuclide therapy with radiolabelled peptide-based probes. The prototypes are analogs of somatostatin which are routinely used in the clinic. More recent developments include somatostatin analogs with a broader receptor subtype profile or with antagonistic properties. Many other peptide families such as bombesin, cholecystokinin/gastrin, glucagon-like peptide-1 (GLP-1)/exendin, arginine-glycine-aspartic acid (RGD) etc. have been explored during the last few years and quite a number of potential radiolabelled probes have been derived from them. On the other hand, a variety of strategies and optimized protocols for efficient labelling of peptides with clinically relevant radionuclides such as {sup 99m}Tc, M{sup 3+} radiometals ({sup 111}In, {sup 86/90}Y, {sup 177}Lu, {sup 67/68}Ga), {sup 64/67}Cu, {sup 18}F or radioisotopes of iodine have been developed. The labelling approaches include direct labelling, the use of bifunctional chelators or prosthetic groups. The choice of the labelling approach is driven by the nature and the chemical properties of the radionuclide. Additionally, chemical strategies, including modification of the amino acid sequence and introduction of linkers/spacers with different characteristics, have been explored for the improvement of the overall performance of the radiopeptides, e.g. metabolic stability and pharmacokinetics. Herein, we discuss the development of peptides as radiopharmaceuticals starting from the choice of the labelling method and the conditions to the design and optimization of the peptide probe, as well as some recent developments, focusing on a selected list of peptide families, including somatostatin

  20. Multi-disciplinary collaboration in radiopharmaceutical chemistry

    International Nuclear Information System (INIS)

    Nozaki, Tadashi

    1989-01-01

    Various possibilities often exist in each step of radiopharmaceutical preparation, and multi-disciplinary knowledge and collaboration are necessary for improved choice of the preparation conditions. In the radionuclide production step, proton bombardment of a separated nuclide target usually exceeds other bombardments of natural targets. Isotope separation by laser-chemical method is expected to soon offer several enriched nuclides useful as the target in enough amount and moderate price. The design and preparation of radiopharmaceuticals will be directly influenced by further progress of enzymology and immunology. Nondestructive, continuous observation of chemical changes in vivo is a longing of radiochemists, and may be realized gradually through elaborate examination of chemical effects in Mossbauer absorption, γ-γ angular correlation, EC X-ray properties, and positron annihilation. Present knowledge and techniques in radiopharmaceutical chemistry, on the other hand, can be utilized effectively in other fields of life sciences

  1. Use of radiopharmaceuticals for treating bone metastases

    International Nuclear Information System (INIS)

    Alberti Ramírez, Alejandro; Morín Zorrilla, José; Cruz Arencibia, Jorge

    2016-01-01

    Cancer prevalence is estimated at around 2% of the population and on average between 64-80% of patients with solid tumors develop bone metastases, being breast tumors, lung and prostate those who do more frequency. In this paper an estimate of the prevalence of bone pain from metastases, with reference to the data reported in the literature is presented. the different treatment techniques are summarized for pain management with special emphasis on Radionuclidic therapy, analyzing the different factors to consider for the selection of suitable radiopharmaceutical. cost data and cost-benefit of some radiopharmaceuticals for the purpose to take into account during their selection are provided. It is concluded that although the treatment of metastatic bone disease requires multidisciplinary therapies, Radionuclidic therapy is not sufficiently used, particularly by inadequate perception of risks and costs of radiopharmaceuticals, despite the undeniable support of its efficacy and tolerability. (author)

  2. Radiopharmaceutical potential of I-131 labelled diazepam

    International Nuclear Information System (INIS)

    Yurt, F.; Unek, P.; Asikoglu, M.; Baggi, S.; Erener, G.; Ozkilic, H.; Uluc, F.; Tuglular, I.

    1998-01-01

    In this study, diazepam is a derivative of the 1.4 benzodiazepine family that the most widely used drug as anticonvulsant agent has been labeled with I-131, as a new radiopharmaceutical and its radiopharmaceutical potential has been determined. Labeling of diazepam has been performed by iodogen method and optimum labeling conditions have been determined. Optimum reaction conditions are 1 mg for iodogen amount; 1-5 mg for diazepam amount, 15-20 minutes for reaction time and room temperature for reaction temperature. Specific activity of labeled compound was 0,15 Ci/mmol level. N-octanol/water ratio was found 1.9 for 131 IDZ ( 131 I labeled diazepam). In vivo experiments have been carried out to determine radiopharmaceutical potentials of labeled compound. Biodistribution studies on rats showed that 131 IDZ have accumulated in kidneys, liver, lungs and brain tissues. Scintigraphic results taken with gamma camera on rabbits agree with biodistribution results of rats. (author)

  3. Exposure of croatian population to radiopharmaceuticals

    International Nuclear Information System (INIS)

    Prlic, I.; Suric Mihic, M.; Marovic, G.; Mestrovic, T.; Mrcela, I.; Cerovac, Z.; Golubovic, D.; Hajdinjak, M.

    2010-01-01

    The aim of this paper is to call attention to the exposure of Croatian population to open sources of ionising radiation used in medical diagnostics, radiopharmaceuticals in particular, whose initial activity is very high. Without proper exposure monitoring, it is not possible to establish the effective dose per capita, but we have estimated it to be between 6.8 μSv and 7.0 μSv for this type of internal exposure, based on a very loose assumption that about 35,000 diagnostic procedures with radiopharmaceuticals are performed in Croatia every year. This calls for further research that would eventually lead to limiting the doses received through exposure to radiopharmaceuticals. (authors)

  4. Radiopharmaceuticals for thyroid imaging: a review

    International Nuclear Information System (INIS)

    Nishiyama, H.

    1979-01-01

    A review of radiopharmaceuticals which have been used for thyroid imaging was made with special emphasis on palpable thyroid nodules. An attempt was made to evaluate cold nodules derived from imaging methods using radioiodine or Tc-99m pertechnetate, followed by a successive application of another radiopharmaceutical. An attempt was also made to understand the patho-physiology of various thyroid disorders. The latter was based on the accumulated cases with discordant images between radioiodine and Tc-99m pertechnetate, and also on the iodine content within the gland by means of fluorescent techniques. Better radiopharmaceuticals are anxiously awaited in order to realize the distinction between benign and malignant thyroid disorders at the preoperative decision-making stage

  5. The safe and effective use of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Trott, N.G.

    1982-01-01

    In the medical applications of radionuclides, we have to arrange effective radiation protection of patients, staff and general public, maintain high standards of pharmaceutical safety and ensure that the radiopharmaceuticals are effective in use. The influence of the 1976 Council of the European Communities Euratom Directive in producing legislation in the United Kingdom controlling medical work with radioactivity is discussed. Attention is drawn to current studies in the dosimetry of radiopharmaceuticals, and some of the problems that continue to arise in evaluating the dosimetry and possible hazards of isotopes of iodine are discussed. Developments in facilities for preparing radiopharmaceuticals in hospital laboratories are considered and a short report is given of an extensive study of quality control procedures which showed that it was difficult to justify their use as a routine on established products. (Author)

  6. Applications and development trend of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kim, J.R.

    1978-01-01

    Present status of radiopharmaceuticals applications and the trend of the development are extensively reviewed and discussed. The followings are manifested: a) Among the various radionuclides, those of short lived, accelerator produced, and having moderate radiation energies are becoming popular. b) Diagnosis using various labelled molecules are considered to be the most active field in nuclear medicine. c) Development of radiopharmaceuticals for tumor localization studies is one of the trends. d) The use of various convenient kits of both in-vitro radioligand assay, and in-vivo instant labelling is now an enormous domain in nuclear medicine. A great stride is also made in the development of automation technique. Upon it, an urgent development of some new radiopharmaceuticals having local characteristics is proposed. (author)

  7. Radiopharmaceutical prescription in nuclear medicine departments

    International Nuclear Information System (INIS)

    Biechlin-Chassel, M.L.; Lao, S.; Bolot, C.; Francois-Joubert, A.

    2010-01-01

    In France, radiopharmaceutical prescription is often discussed depending to which juridical structure the nuclear medicine department is belonging. According to current regulation, this prescription is an obligation in a department linked to hospital with a pharmacy department inside. But situation remains unclear for independent nuclear medicine departments where physicians are not constrained to prescribe radiopharmaceuticals. However, as radiographers and nurses are only authorized to realize theirs acts in front of a medical prescription, one prescription must be realized. Nowadays, computerized prescription tools have been developed but only for radiopharmaceutical drugs and not for medical acts. In the aim to achieve a safer patient care, the prescription regulation may be applied whatever differences between nuclear medicines departments. (authors)

  8. Synthesis of the radiopharmaceuticals for positron emission tomography

    International Nuclear Information System (INIS)

    Biricova, V.; Kuruc, J.

    2007-01-01

    In this paper is shown a short overview of the biogenic positron radiopharmaceuticals production and a brief summary of some PET preparation synthesis. At the end the overview of some forward-looking positron radionuclides, which can be used for a preparation of the PET radiopharmaceuticals is said. A short review of diagnostic use of PET radiopharmaceuticals is presented (authors)

  9. In vitro test for pyrogenes in radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Jovanovic, V; Zmbova, B; Bzenic, J [Institut za Nuklearne Nauke Boris Kidric, Belgrade (Yugoslavia); Berkes, J [Institut za Biohemije, Belgrade (Yugoslavia)

    1978-05-01

    Procedure and results of determination of pyrogenic substances in radiopharmaceutical preparations by an in vitro method based on the reaction between bacterial endotoxine and Limulus Amebocyte Lysate are presented. The advantage of this method as compared to the test in experimental animals performed so far has also been analyzed and proved by the fact that it enables avoidance of introduction of radioactive materials in experimental animals and of radiation effects on the results obtained in efficiency studies. The in vitro method is a quick one and requires only small quantities of the radiopharmaceutical preparation to be examined.

  10. Fetal absorbed doses by radiopharmaceutical administration

    International Nuclear Information System (INIS)

    Rojo, Ana M; Gomez Parada, Ines M.; Di Trano, Jose L.

    2000-01-01

    The radiopharmaceutical administration with diagnostic or therapeutic purpose during pregnancy implies a prenatal radiation dose. The dose assessment and the evaluation of the radiological risks become relevant due to the great radiosensitivity of the fetal tissues in development. This paper is a revision of the available data for estimating fetal doses in the cases of the more frequently used radiopharmaceuticals in nuclear medicine, taking into account recent investigation in placental crossover. The more frequent diagnostic and therapeutic procedures were analyzed according to the radiation doses implied. (author)

  11. Tc: chemistry and radiopharmaceuticals: a prospectus

    International Nuclear Information System (INIS)

    Tulip, T.H.

    1987-01-01

    The recent explosion in technetium chemistry evident in this symposium promises to continue unabated. As in the past, radiopharmaceutical applications will lead to new Tc chemistry. In this lecture the author will discuss those areas which appear most fertile based on chemical and radiopharmaceutical criteria. Among these will be new organometallic Tc chemistry (e.g., Tc(CNR) 6 cations), Tc complexes as metabolic tracers (e.g., Tc-analogs to FDG), and peptide-based Tc chelators (e.g., Tc-metallothionein)

  12. Molecular modelling and radiopharmaceutical design

    International Nuclear Information System (INIS)

    Neves, M.; Gano, L.; Costa, M.C.; Raminhos, H.; Rosado, M.; Fausto, R.

    2002-01-01

    Aim: Among several headings for radiopharmaceuticals (RPs) design, molecular modelling (MM) could be used for the prediction of ligands and metal-complexes structures. Using MM it is also possible to simulate molecular interactions between predicted structures and specific biomolecules. Bisphosphonates (BPs) are ligands that are able to coordinate radioactive metals, such as 153 Sm, 166 Ho, 186 Re, etc., but they are all polymeric complexes difficult to characterize. It is reported that the bone uptake does not depend on the nature of metal center, but is primarily driven by the nature of the ligand, as in the case of HEDP-M (M= 99m Tc, 186 Re, 113 Sn). So, it would be interesting to estimate the relevant molecular properties of BPs by MM, simulate their interaction with hydroxyapatite (HAP) the main bone component, and then correlate the predicted molecular parameters with experimental data obtained from HAP binding and biodistribution studies of BPs carrying radioactive metals. Materials and Methods: The molecular structures and preferred conformations of BPs differing in the length of the aliphatic chain attached to their substituted amine groups (pami-dronate, olpadronate and ibandronate) were obtained using the second-generation CVFF 950 (version 1.01) force field of Hwang et al. Simulation of the interactions between the studied BPs and HAP were performed using a Cerius-2 system of programs running on a Silicon Graphics O2 workstation. BPs- 153 Sm complexes were synthesized and characterized by ITLC. Their binding to HAP and in vivo biodistribution studies were carried out as usual described in literature. Results: A direct correlation could be established between in vitro BPs affinity towards HAP and their corresponding energies from the Coulomb interactions involving the N and P atoms of the studied BPs bound to the HAP (0,0,1) surface and the nearest Ca atoms of HAP. The BPs- 153 Sm showing the highest binding to HAP and skeletal uptake are those which

  13. Radiopharmaceutical therapy of brain tumours

    International Nuclear Information System (INIS)

    Riva, P.; Franceschi, G.; Frattarelli, M.; Casi, M.; Santimaria, M.; Cremonini, A.M.; Guiducci, G.; Riva, N.

    1999-01-01

    Full text: The loco-regional radioimmunotherapy (RIT) of high-grade malignant glioma may represent a further favourable therapeutic approach, able to ameliorate the ominous prognosis of these diseases. The anti-tenascin monoclonal antibodies (MAbs) are directly injected in the tumoral bed after the operation. In the first pilot study, 81 glioblastoma patients received the MAbs (BC2 and BC4) labelled with 131 I (mean dose 2035 MBq). The toxicity was absent. The median survival was prolonged up to 25 months and the response rate (PR + CR + NED: no evidence of disease in cases with minimal lesions after customary treatments) was 44%. More recently, 90 Y instead of 131 I was employed. The benzyl-DTPA chelator was utilized for 90 Y conjugation. A phase I study was performed in 20 glioblastoma patients, who previously received all conventional regimens, but with progressive tumour. They were intralesionally given escalating 90 Y doses (185, 370, 555, 740, 925 MBq), 4 cases were included in each incremental level. No change in haematology, liver and renal parameters were encountered. The brain MTD was 925 MBq. The radiopharmaceutical remained in high amount only in the neoplastic area and did not diffuse in normal brain region nor in normal organs. The radiation dose to the tumour was, on average, 0.54 Gy per MBq of 90 Y administered (about 4 times higher in comparison to 131 I). Now a phase II study has been initiated. 30 evaluable patients (23 glioblastoma and 7 anaplastic astrocytoma; 8 newly diagnosed and 22 recurrent tumours) who have been already treated with surgery and radiotherapy, underwent loco-regional RIT, by administering a mean 90 Y dose of 740 MBq; in many cases multiple cycles were given. The median survival of patients who had the antibody infusion when their tumour burden was reduced was 28 months. The objective response consisted of 8 PD, 5 SD, 11 PR, 1 CR and 4 NED. The global response rate (PR + CR + NED) was 53.3% (47.8% in glioblastoma and 75.7% in

  14. Radiopharmaceutical chelates and method of external imaging

    International Nuclear Information System (INIS)

    Loberg, M.D.; Callery, P.S.; Cooper, M.

    1977-01-01

    A chelate of technetium-99m, cobalt-57, gallium-67, gallium-68, indium-111 or indium-113m and a substituted iminodiacetic acid or an 8-hydroxyquinoline useful as a radiopharmaceutical external imaging agent. The invention also includes preparative methods therefor

  15. Pain palliative Radiopharmaceuticals; Radiofarmacos paliativos del dolor

    Energy Technology Data Exchange (ETDEWEB)

    Gonzalez, B M [Instituto Nacional de Pediatria (Mexico)

    1994-12-31

    A pain relieving agents based on {beta} emitters mainly and in some cases a complex preparation are being given for bone metastasis in relation with breast,prostate and lung carcinoma with good performance in clinical practice.Several radionuclides and radiopharmaceuticals are mentioned giving strength to those newly proposed, 153Sm and 186Re.Bibliography.

  16. Radiopharmaceuticals for diagnosis and treatment of arthritis

    International Nuclear Information System (INIS)

    Hosain, F.; Haddon, M.J.; Hosain, H.; Drost, J.K.; Spencer, R.P.

    1990-01-01

    A brief review is given of radiopharmaceuticals for the diagnosis and treatment of arthritis. Topics covered include the pathophysiology of arthritis and the basis for the use of radiotracers, diagnostic procedures and radiotracer applications and therapeutic approaches and radionuclide applications. (UK)

  17. Safety and efficacy of radiopharmaceuticals 1987

    International Nuclear Information System (INIS)

    Kristensen, K.; Norbygaard, E.

    1987-01-01

    In this text aspects of the development of new radiopharmaceuticals are reviewed with particular reference to products of biological origin such as monoclonal antibodies and human cells. Also included in this survey are the legal aspects of the introduction of new pharmaceuticals and good radiopharmacy practice

  18. Radiopharmaceutical quality control-Pragmatic approach

    International Nuclear Information System (INIS)

    Barbier, Y.

    1994-01-01

    The quality control must be considered in a practical manner. The radiopharmaceuticals are drugs. They must satisfy the quality assurance control. These products are then conform to Pharmacopeia. But sometimes the user must control some data especially radiochemical purity and pH value. On all the administered solutions four controls are compulsory: radionuclide identity, administered radioactivity, organoleptic character and pH

  19. Design and Development of New Radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Wagner, Jr., H. N.; Stern, H. S.; Rhodes, B. A.; Reba, R. C.; Hosain, F.; Zolle, I. [Johns Hopkins Medical Institutions, Baltimore, MD (United States)

    1969-05-15

    The major factors in the design of a new radiopharmaceutical for radioisotope scintigraphy are the photon energy of the radionuclide, the ability to incorporate the radionuclide insuitable chemical and biological form, the radiation dose to the patient, and the cost of production of the radiopharmaceutical. In this laboratory, the radionuclides, indium-113m and ytterbium-169, and technetium-99m, have been incorporated into a variety of radiopharmaceuticals. These include particles suitable for lung and liver studies, chelates for brain and kidney studies, and ionic forms for blood pool imaging. Studies in experimental animals and man indicate that these agents offer certain advantages over previously available radiopharmaceuticals. By providing larger numbers of photons, they permit more precise temporal and spatial resolution. The longer half-life of the tin-113 parent radionuclide from which indium-113m can be eluted makes indium-113m readily available, even at sites distant from the source of production. The tin-indium generator system need be purchased only every five months rather than weekly as in the case of the widely used molybdenum-technetium system. The ytterbium-radionuclide in the chemical form of a chelate is particularly useful as an inexpensive agent that provides high photon yields for renal and brain imaging. The rapid and complete biological excretion results in low radiation dose while the longer physical half-life greatly extends the shelf-life. (author)

  20. 18F based radiopharmaceuticals and automation of synthesis. New 18F radiopharmaceuticals

    International Nuclear Information System (INIS)

    Garg, P.K.; Garg, S.

    2007-01-01

    Fluorine-18 is one of the most commonly used positron emitting isotopes for clinical and research needs with a physical half-life of 110 min. PET isotopes deposit higher radiation absorbed dose than nuclear medicine isotopes. Because of their relatively short half-life, larger quantities of these isotopes are used at the start of synthesis. Therefore, increased shielding and remote automated synthesis are essential for their safe handling. Unlike other radiopharmaceuticals, it is not practical to produce PET radiopharmaceuticals at a central location for subsequent distribution to clinical and research facilities around the country. This limitation compels various academic and research facilities to manufacture their own PET radiopharmaceuticals for in-house use. For multiple reasons, 18 F fluorodeoxyglucose ([ 18 F]FDG) is one of the most commonly used radiopharmaceuticals. The synthesis of [ 18 F]FDG has been optimized and automated, thus allowing independent laboratories to produce this radiopharmaceutical safely. Nonetheless, these laboratories should acquire resources and expertise to fulfil ever increasing regulatory requirements for the safe production and usage of PET radiopharmaceuticals. In addition to [ 18 F]FDG, a wide array of new and novel radiotracers is being developed to explore various biological processes. This paper emphasizes the fact that it is possible to accomplish research and fulfil clinical needs within an academic setting with modest resources. A careful assessment of the need for due diligence in radiation safety issues is very important for the longevity of any PET research endeavour. (author)

  1. Radiopharmaceuticals and applications; Preparacoes radiofarmaceuticas e suas aplicacoes

    Energy Technology Data Exchange (ETDEWEB)

    Oliveira, Rita [Universidade Fernando Pessoa, Porto (Portugal). Fac. de Ciencias da Saude; Santos, Delfim; Ferreira, Domingos; Coelho, Pedro [Universidade do Porto (Portugal). Fac. da Farmacia; Veiga, Francisco, E-mail: fveiga@ci.uc.pt [Universidade de Coimbra (Portugal). Fac. de Farmacia

    2006-04-15

    Radiopharmaceuticals are substances without pharmacological activity that are used in Nuclear Medicine for diagnosis and therapy for several diseases. Diagnosis radiopharmaceuticals generally emit {gamma} radiation or positrons ({beta}+), because their decay originates penetrating electromagnetic radiation that can cross the tissues and be externally detected. Therapeutic radiopharmaceuticals must include in their composition ionized particles emission nucleus ({alpha}, {beta}{sup -} or Auger electrons), since their action is based in selective tissue destruction. There are two main methods for image acquisition: SPECT (Single Photon Emission Computerized Tomography) that uses {gamma} emission radionuclides ({sup 99m}Tc, {sup 123}I, {sup 67}Ga, {sup 201}Tl) and PET (Positron Emission Tomography) that uses positron emission radionuclides like {sup 11}C, {sup 13}N, {sup 15}O, {sup 18}F. Radiopharmaceuticals can be classified into perfusion radiopharmaceuticals (first generation) or specific radiopharmaceuticals (second generation). Perfusion radiopharmaceuticals are transported in the blood e reach the target organ in the direct proportion of the blood stream. Specific radiopharmaceuticals contain a biologically active molecule that binds to cellular receptors that must remain biospecific after binding to the radiopharmaceutical. For this type of radiopharmaceuticals, tissue or organ uptake is determined by the biomolecule capacity of recognizing receptors in those biological structures. Radiopharmaceuticals are produced ready to use, in cold kits or in autologal preparations. According to the preparation type there is a different quality control procedure. Most of the radiopharmaceuticals used nowadays are of the perfusion type. Research focus in the development of specific radiopharmaceuticals that can provide information, at the molecular level, of biochemical alterations associated to different pathologies. (author)

  2. Adverse reactions to radiopharmaceuticals and their reporting

    International Nuclear Information System (INIS)

    Keeling, D.

    1988-01-01

    Adverse reactions to radiopharmaceuticals are uncommon and the great majority that do occur are relatively trivial and require little or no treatment. Reporting schemes for such reactions are in operation in a number of countries but they vary in their effectiveness and the best collect only a minority of cases; only 10-15% of total reactions in the United Kingdom, for instance. Radiopharmaceutical reaction reports in the UK for the period 1982-1987 are summarised in a table and then discussed. Reliable incidence figures for such reactions are difficult to obtain. The UK figure is estimated here to be near 1 per 2000. The great majority of reactions reported are of an idiopathic hypersensitivity nature and are related to the chemical form of the material; radiation has very rarely caused recognisable problems since the discontinuance of colloid gold for lymphatic clearance studies. The value of such reaction reports is their role as a forewarning to doctors

  3. Detection of sentinel nodes with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Yokoyama, Kunihiko; Michigishi, Takatoshi; Kinuya, Seigo; Konishi, Shota; Nakajima, Kenichi; Tonami, Norihisa

    2000-01-01

    Sentinel lymph nodes have been found to be an indicator of lymph node metastasis in breast cancer. In Japan, the theory and concept of sentinel lymph nodes in breast cancer have begun to be applied to carcinomas of the digestive system. Based on clinical experience in the detection of sentinel lymph nodes with radiopharmaceuticals, differences and similarities between the radiopharmaceuticals, methods, and techniques used to detect sentinel lymph nodes have been assessed in relation to breast cancer and carcinomas of the digestive system (including carcinomas of the esophagus and large intestine). The greatest difference between the methods used for breast and digestive cancers is the site of administration of the radiopharmaceutical. In breast cancer, the radiopharmaceutical is administered into a superficial organ (i.e., the mammary gland), whereas in carcinomas of the digestive system, it is administered into a deep organ (i.e., digestive tract). Another obvious difference is in lymph flow, i.e., the flow of the mammary glands is subcutaneous whereas lymph flow in the digestive tract is submucosal. Two radionuclide diagnostic methods are available to detect sentinel lymph nodes: sentinel lymphoscintigraphy with a gamma camera and a method that involves the use of a gamma probe intraoperatively. Radiopharmaceuticals used to detect sentinel lymph nodes must be smoothly transferred from the site of administration into the lymph, and uptake by the sentinel lymph node must continue for a long time without excessive flowing to lower reaches. The optimal particle size remains a matter of controversy, and no radiopharmaceuticals appropriate for lymphoscintigraphy have ever been approved in Japan. The authors compared the pharmacokinetics of three different radiopharmaceuticals used for sentinel lymphoscintigraphy in breast cancer ( 99m Tc-labeled albumin, 99m Tc-labeled tin colloid, and 99m Tc-labeled phytic acid) and founded that the detection rate was lowest with

  4. Innovative radiopharmaceuticals in oncology and neurology

    CERN Document Server

    Barbet, Jacques; Chérel, Michel; Guilloteau, Denis

    2017-01-01

    The aim of this Research Topic was to assemble a series of articles describing basic, preclinical and clinical research studies on radiopharmaceuticals and nuclear medicine. The articles were written by attendees of the third Nuclear Technologies for Health Symposium (NTHS, 10th-11th March 2015, Nantes, Frances) under the auspices of the IRON LabEx (Innovative Radiopharmaceuticals for Oncology and Neurology Laboratory of Excellence). This French network, gathering approximately 160 scientists from 12 academic research teams (Funded by “investissements d’Avenir”), fosters transdisciplinary projects between teams with expertise in chemistry, radiochemistry, radiopharmacy, formulation, biology, nuclear medicine and medical physics. The 12 articles within this resulting eBook present a series of comprehensive reviews and original research papers on multimodality imaging and targeted radionuclide therapy; illustrating the different facets of studies currently conducted in these domains.

  5. Computational chemistry and metal-based radiopharmaceuticals

    International Nuclear Information System (INIS)

    Neves, M.; Fausto, R.

    1998-01-01

    Computer-assisted techniques have found extensive use in the design of organic pharmaceuticals but have not been widely applied on metal complexes, particularly on radiopharmaceuticals. Some examples of computer generated structures of complexes of In, Ga and Tc with N, S, O and P donor ligands are referred. Besides parameters directly related with molecular geometries, molecular properties of the predicted structures, as ionic charges or dipole moments, are considered to be related with biodistribution studies. The structure of a series of oxo neutral Tc-biguanide complexes are predicted by molecular mechanics calculations, and their interactions with water molecules or peptide chains correlated with experimental data of partition coefficients and percentage of human protein binding. The results stress the interest of using molecular modelling to predict molecular properties of metal-based radiopharmaceuticals, which can be successfully correlated with results of in vitro studies. (author)

  6. Radiopharmaceutical chelates and method of external imaging

    International Nuclear Information System (INIS)

    1976-01-01

    The preparation of the following chemicals is described: chelates of technetium-99m, cobalt-57, gallium-67, gallium-68, indium-111 or indium-113m and a substituted iminodiacetic acid or an 8-hydroxyquinoline useful as a radiopharmaceutical external imaging agent. The compounds described are suitable for intravenous injection, have an excellent in vivo stability and are good organ seekers. Tin(II) choride or other tin(II) compounds are used as chelating agents

  7. Radiation absorbed dose from medically administered radiopharmaceuticals

    International Nuclear Information System (INIS)

    Roedler, H.D.; Kaul, A.

    1975-01-01

    The use of radiopharmaceuticals for medical examinations is increasing. Surveys carried out in West Berlin show a 20% average yearly increase in such examinations. This implies an increased genetic and somatic radiation exposure of the population in general. Determination of radiation exposure of the population as well as of individual patients examined requires a knowledge of the radiation dose absorbed by each organ affected by each examination. An extensive survey of the literature revealed that different authors reported widely different dose values for the same defined examination methods and radiopharmaceuticals. The reason for this can be found in the uncertainty of the available biokinetic data for dose calculations and in the application of various mathematical models to describe the kinetics and calculation of organ doses. Therefore, the authors recalculated some of the dose values published for radiopharmaceuticals used in patients by applying biokinetic data obtained from exponential models of usable metabolism data reported in the literature. The calculation of organ dose values was done according to the concept of absorbed fractions in its extended form. For all radiopharmaceuticals used in nuclear medicine the energy dose values for the most important organs (ovaries, testicles, liver, lungs, spleen, kidneys, skeleton, total body or residual body) were recalculated and tabulated for the gonads, skeleton and critical or examined organs respectively. These dose values are compared with those reported in the literature and the reasons for the observed deviations are discussed. On the basis of recalculated dose values for the gonads and bone-marrow as well as on the basis of results of statistical surveys in West Berlin, the genetically significant dose and the somatically (leukemia) significant dose were calculated for 1970 and estimated for 1975. For 1970 the GSD was 0.2 mrad and the LSD was 0.7 mrad. For 1975 the GSD is estimated at < 0.5 mrad and the

  8. Radiopharmaceuticals to 99mTc

    International Nuclear Information System (INIS)

    Leon Cabana, Alba

    1994-01-01

    Studies about 99m Tc had demonstrated that have favorable properties for support diagnostic proceedings in nuclear medicine. This physical and chemical properties used for obtain another radiopharmaceuticals have been employed through re actives kits labelled with Tc 99m . A brief description was given about 99m utilities in diagnostic techniques such as endothelium reticular system,renal and hepatic studies,bone scintillators,cardiac diagnostic and cerebral perfusion

  9. Considerations and controversies in the selection of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Chilton, H.M.; Cowan, R.J.

    1987-01-01

    When a radiopharmaceutical is selected for a specific study, multiple factors must be considered to ensure that optimum clinical information will be provided with minimum radiation exposure to the patient and laboratory personnel. In this endeavor, certain questions must be considered. What are the nuclear properties of the available radiopharmaceuticals? For the organ to be studied, are there multiple radiopharmaceutical localization pathways? If so, which is best suited to provide the desired diagnostic information? Does the presence of certain clinical factors preclude the use of some radiopharmaceuticals and require the use of others? Do certain radiopharmaceuticals have overriding radiopharmacologic properties which limit their usefulness for the evaluation of certain clinical situations? Finally, how significant are non-clinical properties such as cost, availability, and product formulation? In this chapter, some of these areas and several situations which illustrate the radiopharmaceutical selection process are discussed

  10. The ARPANSA quality assurance program for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Baldas, J.; Ivanov, Z.

    2003-01-01

    Full text: The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) conducts a radiopharmaceutical quality assurance test program in which radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications. Where the radiopharmaceutical is the subject of a monograph in the British Pharmacopoeia or the European Pharmacopoeia, then the specifications given in these Pharmacopoeias are adopted. Where a monograph is only available in the US Pharmacopoeia, then this specification is generally adopted. In other cases the specifications quoted have been adopted by this Agency. Animal biodistribution testing was discontinued in 1997 due to resource limitation. Samples for testing were obtained through commercial channels. All technetium-99m cold kits were reconstituted according to the directions in the package insert using Sodium Pertechnetate [ 99m Tc] injection. The results of testing conducted by the ARPANSA during 1984-1999 are summarised. A significant cause of failure to meet full specifications has been due to non-compliance of the vial/package labels. Copyright (2003) The Australian and New Zealand Society of Nuclear Medicine Inc

  11. A study on bacterial endotoxins test of radiopharmaceuticals with limulus agent

    Energy Technology Data Exchange (ETDEWEB)

    Suozhen, Bai; Kai, Luyu; Cheng, Luo [Academia Sinica, Beijing, BJ (China). Inst. of Atomic Energy; Ruiting, Zhang; Zhenmin, Xia [National Inst. for the Control of Pharmaceutical and Biological Products (China)

    1989-08-01

    The feasibility of endotoxins test of radiopharmaceuticals with limulus agent and the approach to take off the inhibition/enhancement effect of radiopharmaceuticals on limulus agent have been studied. Results of the test for 8 radiopharmaceuticals have been given.

  12. The progress on researching method and metabolism of positron radiopharmaceutical

    International Nuclear Information System (INIS)

    Gan Hongmei; Qiao Jinping; Kong Aiying; Zhu Lin

    2010-01-01

    Positron radiopharmaceuticals are mainly used for PET studies, which are used in the field of nuclear medicine as tracers in the diagnosis and treatment of many diseases. They have important position and function in the clinical diagnosis and treatment. Metabolism or biotransformation will happen when PET radio-pharmaceuticals enter into the body. Understanding the metabolic fate of radiopharmaceutical probes is essential for an accurate analysis and interpretation of positron emission tomography imaging. The recent research progress on PET radiopharmaceuticals metabolism was reviewed in this paper, including the metabolism characteristics, research methods, analytical techniques and so on. (authors)

  13. Prospective production of radioisotopes and radiopharmaceuticals in divisions of IPPE

    International Nuclear Information System (INIS)

    Terentyev, G.O.

    2001-01-01

    The first reason to commence the work on production of radioisotope production in IPPE, was the requirement of Russia medicine for original generators of technetium. The essential extension of their production in conditions of Moscow city has met the declaiming of the Moscow urban authorities. The important moment was that, in IPPE were objective possibilities to deployment the production of radioisotope production. Nowadays, nomenclature of the radioisotopes which have been produced in IPPE, constitutes 29 positions. The profile of production of radioisotope production was generated also. Restricted possibilities of the ray base, from one side, and the needs(requirement) of domestic medicine with other, in main have spotted this profile. The raw isotopes constitute a minority - on sales volumes ∼ 20 % (in main abroad), the defining part is constituted the form ready for the use by ∼ 80 % (in main in Russia). All 'know-how' is conditionally possible to divide into 3 categories: Base. It is technologies provided with an operating production sector, guaranteeing stable on quality production having a rather wide seller's market; Perspective. It is those technologies, in which the main stages of RESEARCH and DEVELOPMENT are fulfilled with positive result, but the working sites yet are not generated, and on the market are delivered only some samples of production. Are guessed RESEARCH AND DEVELOPMENT on perfecting the technology; Preparative. The technology, on which there are no regular orders, is not required of an individual working site. Sometimes it is rather precision operations, bound with usage of unique raw material, with a very stiff price of production. (authors)

  14. Radiopharmaceuticals drug interactions: a critical review

    Directory of Open Access Journals (Sweden)

    Ralph Santos-Oliveira

    2008-12-01

    Full Text Available Radiopharmaceuticals play a critical role in modern medicine primarily for diagnostic purposes, but also for monitoring disease progression and response to treatment. As the use of image has been increased, so has the use of prescription medications. These trends increase the risk of interactions between medications and radiopharmaceuticals. These interactions which have an impact on image by competing with the radiopharmaceutical for binding sites for example can lead to false negative results. Drugs that accelerate the metabolism of the radiopharmaceutical can have a positive impact (i.e. speeding its clearance or, if repeating image is needed, a negative impact. In some cases, for example in cardiac image among patients taking doxirubacin, these interactions may have a therapeutic benefit. The incidence of drug-radiopharmaceuticals adverse reactions is unknown, since they may not be reported or even recognized. Here,we compiled the medical literature, using the criteria of a systematic review established by the Cochrane Collaboration, on pharmaceutical-drug interactions to provide a summary of documented interactions by organ system and radiopharmaceuticals. The purpose is to provide a reference on drug interactions that could inform the nuclear medicine staff in their daily routine. Efforts to increase adverse event reporting, and ideally consolidate reports worldwide, can provide a critically needed resource for prevention of drug-radiopharmaceuticals interactions.Os radiofármacos desempenham função crítica na medicina moderna, primariamente para fins diagnósticos, mas também no monitoramento da progressão de doenças assim como na avaliação de respostas ao tratamento. O uso da tecnologia por imagem tem crescido e conseqüentemente as prescrições de medicamentos (radiofármacos em especial com esse propósito. Este fato, aumenta o risco de interações entre medicamentos e radiofármacos. Interações que podem ter um impacto na

  15. Final Report for research grant "Development of Methods for High Specific Activity Labeling of Biomolecules Using Astatine-211 in Different Oxidation States"

    Energy Technology Data Exchange (ETDEWEB)

    Wilbur, D. Scott [Univ. of Washington, Seattle, WA (United States)

    2011-12-14

    The overall objective of this research effort was to develop methods for labeling biomolecules with higher oxidation state species of At-211. This was to be done in an effort to develop reagents that had higher in vivo stability than the present carbon-bonded At-211-labeled compounds. We were unsuccessful in that effort, as none of the approaches studied provided reagents that were stable to in vivo deastatination. However, we gained a lot of information about At-211 in higher oxidation states. The studies proved to be very difficult as small changes in pH and other conditions appeared to change the nature of the species that obtained (by HPLC retention time analyses), with many of the species being unidentifiable. The fact that there are no stable isotopes of astatine, and the chemistry of the nearest halogen iodine is quite different, made it very difficult to interpret results of some experiments. With that said, we believe that a lot of valuable information was obtained from the studies. The research effort evaluated: (1) methods for chemical oxidation of At-211, (2) approaches to chelation of oxidized At-211, and (3) approaches to oxidation of astatophenyl compounds. A major hurdle that had to be surmounted to conduct the research was the development of HPLC conditions to separate and identify the various oxidized species formed. Attempts to develop conditions for separation of iodine and astatine species by normal and reversed-phase TLC and ITLC were not successful. However, we were successful in developing conditions (from a large number of attempts) to separate oxidized forms of iodine ([I-125]iodide, [I-125]iodate and [I-125]periodate) and astatine ([At-211]astatide, [At-211]astatate, [At-211]perastatate, and several unidentified At-211 species). Information on the basic oxidation and characterization of At-211 species is provided under Objective 1. Conditions were developed to obtain new At-211 labeling method where At-211 is chelated with the DOTA and

  16. Application of a small molecule radiopharmaceutical concept to improve kinetics

    International Nuclear Information System (INIS)

    Jeong, Jae Min

    2016-01-01

    Recently, large molecules or nanoparticles are actively studied as radiopharmaceuticals. However, their kinetics is problematic because of a slow penetration through the capillaries and slow distribution to the target. To improve the kinetics, a two-step targeting method can be applied by using small molecules and very rapid copper-free click reaction. Although this method might have limitations such as internalization of the first targeted conjugate, it will provide high target-to-non-target ratio imaging of radiopharmaceuticals. The majority of radiopharmaceuticals belong to small molecules of which the molecular weight is less than 2000 Da, and the molecular size is smaller than 2 nm generally. The outstanding feature of the small molecule radiopharmaceuticals compared to large molecules is with their kinetics. Their distribution to target and clearance from non-target tissues are very rapid, which is the essential requirement of radiopharmaceuticals. In conclusion, the small molecule radiopharmaceuticals generally show excellent biodistribution properties; however, they show poor efficiency of radioisotope delivery. Large molecule or nanoparticle radiopharmaceuticals have advantages of multimodal and efficient delivery, but lower target-to-non-target ratio. Two-step targeting using a bio-orthogonal copper-free click reaction can be a solution of the problem of large molecule or nanoparticle radiopharmaceuticals. The majority of radiopharmaceuticals belong to small molecules of which the molecular weight is less than 2000 Da, and the molecular size is smaller than 2 nm generally. The outstanding feature of the small molecule radiopharmaceuticals compared to large molecules is with their kinetics. Their distribution to target and clearance from non-target tissues are very rapid, which is the essential requirement of radiopharmaceuticals

  17. Application of a small molecule radiopharmaceutical concept to improve kinetics

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, Jae Min [Dept. of Nuclear Medicine, Seoul National University College of Medicine, Seoul (Korea, Republic of)

    2016-06-15

    Recently, large molecules or nanoparticles are actively studied as radiopharmaceuticals. However, their kinetics is problematic because of a slow penetration through the capillaries and slow distribution to the target. To improve the kinetics, a two-step targeting method can be applied by using small molecules and very rapid copper-free click reaction. Although this method might have limitations such as internalization of the first targeted conjugate, it will provide high target-to-non-target ratio imaging of radiopharmaceuticals. The majority of radiopharmaceuticals belong to small molecules of which the molecular weight is less than 2000 Da, and the molecular size is smaller than 2 nm generally. The outstanding feature of the small molecule radiopharmaceuticals compared to large molecules is with their kinetics. Their distribution to target and clearance from non-target tissues are very rapid, which is the essential requirement of radiopharmaceuticals. In conclusion, the small molecule radiopharmaceuticals generally show excellent biodistribution properties; however, they show poor efficiency of radioisotope delivery. Large molecule or nanoparticle radiopharmaceuticals have advantages of multimodal and efficient delivery, but lower target-to-non-target ratio. Two-step targeting using a bio-orthogonal copper-free click reaction can be a solution of the problem of large molecule or nanoparticle radiopharmaceuticals. The majority of radiopharmaceuticals belong to small molecules of which the molecular weight is less than 2000 Da, and the molecular size is smaller than 2 nm generally. The outstanding feature of the small molecule radiopharmaceuticals compared to large molecules is with their kinetics. Their distribution to target and clearance from non-target tissues are very rapid, which is the essential requirement of radiopharmaceuticals.

  18. Preparation of Radiopharmaceuticals Labeled with Metal Radionuclides

    Energy Technology Data Exchange (ETDEWEB)

    Welch, M.J.

    2012-02-16

    The overall goal of this project was to develop methods for the production of metal-based radionuclides, to develop metal-based radiopharmaceuticals and in a limited number of cases, to translate these agents to the clinical situation. Initial work concentrated on the application of the radionuclides of Cu, Cu-60, Cu-61 and Cu-64, as well as application of Ga-68 radiopharmaceuticals. Initially Cu-64 was produced at the Missouri University Research Reactor and experiments carried out at Washington University. A limited number of studies were carried out utilizing Cu-62, a generator produced radionuclide produced by Mallinckrodt Inc. (now Covidien). In these studies, copper-62-labeled pyruvaldehyde Bis(N{sup 4}-methylthiosemicarbazonato)-copper(II) was studied as an agent for cerebral myocardial perfusion. A remote system for the production of this radiopharmaceutical was developed and a limited number of patient studies carried out with this agent. Various other copper radiopharmaceuticals were investigated, these included copper labeled blood imaging agents as well as Cu-64 labeled antibodies. Cu-64 labeled antibodies targeting colon cancer were translated to the human situation. Cu-64 was also used to label peptides (Cu-64 octriatide) and this is one of the first applications of a peptide radiolabeled with a positron emitting metal radionuclide. Investigations were then pursued on the preparation of the copper radionuclides on a small biomedical cyclotron. A system for the production of high specific activity Cu-64 was developed and initially the Cu-64 was utilized to study the hypoxic imaging agent Cu-64 ATSM. Utilizing the same target system, other positron emitting metal radionuclides were produced, these were Y-86 and Ga-66. Radiopharmaceuticals were labeled utilizing both of these radionuclides. Many studies were carried out in animal models on the uptake of Cu-ATSM in hypoxic tissue. The hypothesis is that Cu-ATSM retention in vivo is dependent upon the

  19. Radiopharmaceuticals for nuclear cardiology; Radiofarmacos para cardiologica nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Leon Cabana, Alba [Universidad de la Republica, Facultad de Quimica (Uruguay)

    1994-12-31

    One of the diagnostic technique periodically used in Nuclear Medicine is the angiographic studi e, employee for detect cardiovascular diseases. The radiopharmaceutical more used in the angiographic ones is 99mTc. Between thetopics described in the present work it find: myocardial infarction, radiopharmaceuticals classification for cardiac studies, labelled proceedings, cardiovascular diseases.

  20. Factors and pharmaceuticals that affect the radiopharmaceuticals bio distributions

    International Nuclear Information System (INIS)

    Gonzalez, B.M.

    1994-01-01

    The pattern of biodistribution of radiopharmaceuticals may be affected by various agents and therapeutical procedures, chemotherapy agents, thyroid hormones, metals, radiotherapy, surgery, anesthetic agents, dialysis other radiopharmaceutical interactions. Recommendations for the detection of altered biodistribution in patients by causes not directly related with the pathology itself was given. pathology itself was given

  1. Radiopharmaceuticals for oncology: status and newer trends- an overview

    International Nuclear Information System (INIS)

    Ramamoorthy, N.; Prabhakar, G.

    1997-01-01

    Radiopharmaceuticals have provided a powerful means in the diagnosis and follow up of cancer patients. Radiopharmaceuticals for the treatment of metastatic thyroid cancer and palliation of metastatic bone pain are in extensive use. Newer agents are on the anvil for more efficacious diagnosis and therapy. This article gives an overview of the status and trends in this context. (author)

  2. Sixth international radiopharmaceutical dosimetry symposium: Proceedings. Volume 2

    Energy Technology Data Exchange (ETDEWEB)

    S.-Stelson, A.T. [ed.] [comp.; Stabin, M.G.; Sparks, R.B. [eds.; Smith, F.B. [comp.

    1999-01-01

    This conference was held May 7--10 in Gatlinburg, Tennessee. The purpose of this conference was to provide a multidisciplinary forum for exchange of state-of-the-art information on radiopharmaceutical dosimetry. Attention is focused on the following: quantitative analysis and treatment planning; cellular and small-scale dosimetry; dosimetric models; radiopharmaceutical kinetics and dosimetry; and animal models, extrapolation, and uncertainty.

  3. Molecular design of 99Tcm labelled radiopharmaceuticals. Pt.2

    International Nuclear Information System (INIS)

    Wang Xuebin; Chu Jinfeng

    2003-01-01

    The structure-activity relationship of 99 Tc m labelled radiopharmaceuticals and the correlative contents of computer aided drug design are introduced. Of them, quantitative structure-activity relationship and its application to design 99 Tc m labelled radiopharmaceuticals are narrated on emphases

  4. Ionisation constants of radiopharmaceuticals by HPLC

    Energy Technology Data Exchange (ETDEWEB)

    Stylli, C.G.; Theobald, A.E.

    It has long been recognised that the pKsub(a) of drugs and radiopharmaceuticals is an important determinant of their biological distribution. In this study an HPLC method for pKa measurement has been developed for radiotracers. It has been validated with several amines and used to estimate the pKsub(a) values of some Tc-99m PnAO complexes by observing the change in chromatographic retention with change in mobile phase pH. The pKsub(a) values were estimated from the data by three methods: derivative analysis, quadratic regression, and the Henderson - Hasselbalch equation.

  5. Ionisation constants of radiopharmaceuticals by HPLC

    International Nuclear Information System (INIS)

    Stylli, C.G.; Theobald, A.E.

    1986-01-01

    It has long been recognised that the pKsub(a) of drugs and radiopharmaceuticals is an important determinant of their biological distribution. In this study an HPLC method for pKa measurement has been developed for radiotracers. It has been validated with several amines and used to estimate the pKsub(a) values of some Tc-99m PnAO complexes by observing the change in chromatographic retention with change in mobile phase pH. The pKsub(a) values were estimated from the data by three methods: derivative analysis, quadratic regression, and the Henderson - Hasselbalch equation. (author)

  6. Trends in radiopharmaceutical dispensing in a regional nuclear pharmacy

    International Nuclear Information System (INIS)

    Basmadjian, G.P.; Johnston, J.; Barker, K.; Ice, R.D.

    1982-01-01

    Dispensing trends for radiopharmaceuticals at a regional nuclear pharmacy over a 51-month period were studied. dispensing records of a regional nuclear pharmacy were analyzed with a forecasting procedure that uses univariate time data to produce time trends and autoregressive models. The overall number of prescriptions increased from 3500 to 5500 per quarter. Radiopharmaceuticals used in nuclear cardiology studies increased from less than 0.1% to 17.5% of total prescriptions dispensed, while radiopharmaceuticals used for brain imaging showed a steady decline from 29% to 11% of total prescriptions dispensed. The demand for other radiopharmaceuticals increased in areas such as renal studies, bone studies, lung studies, liver-function studies, and 67 Ga tumor-uptake studies, and declined slightly for static liver studies. Changes in dispensing trends for radiopharmaceuticals will continue as the practice of nuclear medicine concentrates more on functional studies and as newer imaging techniques become used for other purposes

  7. Evaluation of quality control of radiopharmaceuticals in Nuclear Medicine service

    International Nuclear Information System (INIS)

    Tavares, Jamille A. Lopes; Lira, Renata F. de; Santos, Marcus Aurelio P. dos

    2014-01-01

    Radiopharmaceuticals are a type of pharmaceutical preparation associated with radionuclides with purpose of diagnosis and therapy. Nuclear Medicine Services (NMS) should perform quality control of radiopharmaceuticals according to the recommendations of the manufacturer and scientific evidences accepted by the National Agency Sanitary Surveillance ( Brazilian ANVISA). This study evaluated the quality of the main radiopharmaceuticals in a NMS of the state of Pernambuco in relation to pH and radiochemical purity. The results showed that 96.8% of the radiopharmaceuticals showed radiochemical purity and all pH values were within the range recommended by the American pharmacopoeia. The study found that the quality control when inserted into the NMS, provides important data that allows exclusion of radiopharmaceuticals with low radiochemistry purity, favoring a reliable diagnosis and ensuring good radiation protection practices and biosecurity for patient and occupationally exposed individuals

  8. Radiopharmaceuticals labelled with positron-emitting radioisotopes

    International Nuclear Information System (INIS)

    Comar, D.; Berridge, M.; Maziere, B.; Crouzel, C.

    1982-01-01

    This chapter reviews the preparation of radioisotopes for biochemical and physiological studies and the principal methods for their incorporation into radiopharmaceuticals, while pointing out the problems encountered with their use and considering their medical interest in the following areas: distribution and flow of fluids, metabolic and pharmacokinetic studies. Inorganic and organic radiopharmaceuticals presently in use and most probable to be used in the future are reviewed. It is anticipated that three types of products labelled with 15 O, 13 N, 11 C and 18 F will be developed in the future. The first type includes products which trace general phenomena such as fluid movement or metabolism of sugars, fats and proteins. The compromise between physiological accuracy and imaging technology is discussed in relation to the use of 11 C and 18 F. The second type of product is one to measure more specific parameters such as those of molecular transport kinetics, membrane permeability, cellular pH and receptor-ligand interactions, again with particular reference to 11 C and 18 F. The third type of product discussed is that intended for pharmacology studies, particular reference being made to 68 Ga, 82 Rb. Extensive bibliography. (U.K.)

  9. Preparation of kits for 99Tcm radiopharmaceuticals

    International Nuclear Information System (INIS)

    1992-05-01

    This publication details preparation under Good Manufacturing Practices (GMP) of thirteen widely used 99 Tc m radiopharmaceuticals and their quality assurance practices. The objective of this document is to present to those who intend to launch a kit preparation programme a set of preparation procedures and other relevant information gathered during kit production over a period of more than a decade, to serve as a good starting point. The manuals and monographs included in the document are based on the experience gained in two major centres. The publication of this material is intended to give a typical example, and not the only possible procedure for preparing the kits. Following the essentials of these kit preparation procedures, it is always possible to make alterations to the composition of the kits. The kits described here concern widely used 99 Tc m radiopharmaceuticals which do not require a Single Photon Emission Computed Tomography (SPECT) camera. These examples of the ''first generation'' of kits are not very intricate to prepare. Although it is advisable to have only one agent for a given intended use, a few agents for each purpose, e.g. EHDP and MDP for bone imagining, have been included in the document so that the reader can have some flexibility in selecting a particular kit. 24 refs, 2 figs

  10. In search of scar seeking radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Salehi, N.; Lawlor, J.M.; Lichtenstein, M.; Allaway, M.; Barencevic, A. [Royal Melbourne Hospital, Melbourne, VIC (Australia). Department of Nuclear Medicine]|[University of Melbourne, VIC (Australia)

    1998-03-01

    Full text: Sensitive detection of acute peri-osseous scar tissue should be valuable for detection of partial ligamentous, tears and other common rheumatological conditions including back pain and ligamentous scars. Our aim was to investigate acute scar uptake of {sup 99m}Tc(V)-DMSA (dimercapto-succinic-acid), {sup 99m}Tc-DMAD (di- methyl-aminodiphosphonate) compared to {sup 99m}Tc-MDP (methylen-diphosphonate), the standard bone-scanning radiopharmaceutical. New Zealand white rabbits were anaesthetised and had 5-7cm of their mid-line abdominal wall surgically incised. At 24, 48, 72, 96 and 240 hours post surgery, 74 MBq (2 mCi) of the above radiopharmaceuticals were injected intravenously and scintigraphy performed 2.5 hours later. Relative count rate in scar is tabulated. In conclusion, the increased activity in the acute surgical site and lesser bone uptake confirmed that Tc (V)-DMSA and Tc-DMAD are superior to Tc- MDP for detection of new scar tissue in the region of bone. 1 tab.

  11. Regulatory considerations concerning IND radiopharmaceutical drug products

    International Nuclear Information System (INIS)

    Nissel, M.

    1985-01-01

    The Food and Drug Administration is charged by the Food, Drug, and Cosmetic Act, as presently amended, to assure that any drug introduced into interstate commerce is safe and effective for the purposes for which it is labeled. A radiopharmaceutical is, by definition, a new drug unless there is in effect an approved New Drug Application (NDA) for it. Before the data for the NDA are compiled, investigative studies have to be done. Before such studies can be performed in humans, an exemption from the Act is necessary. This exemption, technically the Claimed Exemption for an Investigational New Drug, is termed the IND. Both the scientific and the administrative requirements for an IND are discussed. For radiopharmaceutical drug products (RDP's), the radiation hazards, as well as the pharmacological ones, must be documented. Should the early studies demonstrate a potential for efficacy in a certain condition or disease state, an investigative protocol for an extended clinical trial is presented. The necessary requirements for Institutional Review Board (IRB) approval and consent forms are discussed. For certain research purposes, uniquely for radioactive drugs, an IND is not required for certain specific studies; the requirements for such a research study, conducted under the auspices of an approved radioactive drug research committee, are outlined

  12. Therapeutic applications of radiopharmaceuticals. Proceedings of an international seminar

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-06-01

    The potential of radionuclides in therapy has been recognised for many decades. A number of radionuclides such as iodine-131, phosphorous-32, yttrium-90 and 1-131 MIBG have been in use for the treatment of many benign and malignant disorders. Recently, however, there has been a significant growth of this branch of nuclear medicine with the introduction of a number of new radionuclides and radiopharmaceuticals for the treatment of metastatic bone pain, neuroendocrine and other tumours. The prospect of localising or treating neoplastic diseases using specific antibodies labelled with radioactive isotopes capable of delivering large amounts of internally administered radiation may have the potential to fulfil the promise of EhrIich's 'magic bullet', which has tantalised investigators worldwide for the past sixty years. Recent success in this area has been largely due to genetic and molecular techniques that now permit production of a large number of suitable peptides and monoclonal antibodies directed against specific epitopes individually characteristic of specific tumours. The input of the radiochemist and the development of labelling techniques that do not destroy the immunological integrity of the monoclonal antibodies have also been essential ingredients of the success story. Recent significant advances in monoclonal antibody techniques for pretargeting make it very likely that radiopharmaceuticals will become an important part of therapy for various cancers. It may also be possible that in addition to the use of beta particles, alpha particles may soon become a mainstay of therapeutic nuclear medicine. Cancer researchers, looking for an extremely potent and highly specific way to target cancer cells, are investigating the use of monoclonal antibodies and peptides attached to alpha emitting radionuclides in early clinical trials. Today the field of radionuclide therapy is going through an extremely interesting and exciting phase and is poised for greater growth

  13. Therapeutic applications of radiopharmaceuticals. Proceedings of an international seminar

    International Nuclear Information System (INIS)

    2001-06-01

    The potential of radionuclides in therapy has been recognised for many decades. A number of radionuclides such as iodine-131, phosphorous-32, yttrium-90 and 1-131 MIBG have been in use for the treatment of many benign and malignant disorders. Recently, however, there has been a significant growth of this branch of nuclear medicine with the introduction of a number of new radionuclides and radiopharmaceuticals for the treatment of metastatic bone pain, neuroendocrine and other tumours. The prospect of localising or treating neoplastic diseases using specific antibodies labelled with radioactive isotopes capable of delivering large amounts of internally administered radiation may have the potential to fulfil the promise of EhrIich's 'magic bullet', which has tantalised investigators worldwide for the past sixty years. Recent success in this area has been largely due to genetic and molecular techniques that now permit production of a large number of suitable peptides and monoclonal antibodies directed against specific epitopes individually characteristic of specific tumours. The input of the radiochemist and the development of labelling techniques that do not destroy the immunological integrity of the monoclonal antibodies have also been essential ingredients of the success story. Recent significant advances in monoclonal antibody techniques for pretargeting make it very likely that radiopharmaceuticals will become an important part of therapy for various cancers. It may also be possible that in addition to the use of beta particles, alpha particles may soon become a mainstay of therapeutic nuclear medicine. Cancer researchers, looking for an extremely potent and highly specific way to target cancer cells, are investigating the use of monoclonal antibodies and peptides attached to alpha emitting radionuclides in early clinical trials. Today the field of radionuclide therapy is going through an extremely interesting and exciting phase and is poised for greater growth

  14. Good Practice for Introducing Radiopharmaceuticals for Clinical Use

    International Nuclear Information System (INIS)

    2016-02-01

    The use of new radiopharmaceuticals can provide extremely valuable information in the evaluation of cancer, as well as heart and brain diseases. Information that often times cannot be obtained by other means. However, there is a perceived need in many Member States for a useful reference to facilitate and expedite the introduction of radiopharmaceuticals already in clinical use in other countries. This publication intends to provide practical support for the introduction of new radiotracers, including recommendations on the necessary steps needed to facilitate and expedite the introduction of radiopharmaceuticals in clinical use, while ensuring that a safe and high quality product is administered to the patient at all times

  15. Radiation hygiene problems of radiopharmaceutical preparation at nuclear medicine units

    International Nuclear Information System (INIS)

    Pekarek, J.; Kukacka, R.

    1977-01-01

    The problems of magistral radiopharmaceuticals preparation are indicated and the layout of a unit for the magistral preparation of radiopharmaceuticals is described. The results are briefly reported of a study of radiation load of laboratory personnel preparing radiopharmaceuticals as against doctors actually applying them. It was found that the exposure of hands to ionizing radiation represents the highest hazard for the laboratory personnel. The most important radiation protection principles are pointed out, such as the use of protective clothing, regular preventive medical examinations, appropriately shielded radionuclides and radionuclide generators to be supplied by manufacturers, and a more frequent rotation of personnel working with active and nonactive preparations. (L.O.)

  16. The radiopharmaceuticals labelled with technetium-99m and the radiopharmacy

    International Nuclear Information System (INIS)

    Bodenant, V.

    1998-01-01

    In less than fifty years, the place of nuclear medicine is become primordial. Among all the radiopharmaceuticals used in nuclear medicine, the technetium-99m is the most used because of its physico-chemical properties and its great availability with the molybdenum-99m - technetium-99m generator. Since 1992, the radiopharmaceuticals, the packages, the generators are included in the pharmaceutic monopole. They are now under the reliability of the radio-pharmacist. This thesis has for object to introduce these different radiopharmaceuticals labelled with technetium-99m and to show the primordial place of the radio-pharmacist in a service of nuclear medicine. (N.C.)

  17. Analytics of radiochmical impurities in radiopharmaceutics. Pt. 4

    International Nuclear Information System (INIS)

    Heide, L.; Stamm, A.; Boegl, W.

    1981-01-01

    The radiopharmaceutics have been compiled in the present volume in the form of a medicament encyclopaedia. The term radiopharmaceutic has been very broadly covered so that one can find pharmaceutics which are applied in clinical routine as well as for veterinary tests or are being or have been tested. Preparates for radio-immuno assays are also recorded. All analysis methods are considered even if these only slightly differ from one another. Methods described in the literature are given which have resulted in a bad or no separation of the radiopharmaceutics from the impurities. (orig./MG) [de

  18. Breast feeding's interruption following radiopharmaceutical administration to nursing mothers

    International Nuclear Information System (INIS)

    Rojo, A.M.; Gomez Parada, I.M.; Dubner, D.; Gisone, P.; Perez de Serrano, M.

    1995-01-01

    The radiopharmaceutical administration to lactating women for therapeutic or diagnostic purpose can achieve a radiological risk to the breast feeding child due to levels of radioactivity in the breast milk. International recommendations regarding safe assumption of nursing mother after radiopharmaceutical administration were analysed. We examined the formula proposed by Rommey et al. to establish objective guidelines in case of the administration of radiopharmaceutical to nursing mothers. The ICRP 54 metabolic model for iodine was modified in order to calculate the suppression breast feeding's period according to the radioactivity measured in the breast milk. (author). 6 refs., 1 fig., 1 tab

  19. Radiopharmaceuticals in metastatic bone pain palliation

    International Nuclear Information System (INIS)

    Garcia, Enrique; Alberti, Alejandro; Cruz Arencibia, Jorge; Morin Zorrilla, Jose

    2012-01-01

    In the present work the current status of the use of Radiopharmaceuticals in the treatment of the pain provoked by bony metastasis is revised. Particular attention is devoted to the used doses, the effectiveness and security of the existent products in the market and in development. The convenience of the routine use in the case of multiple metastasis is established, since the results are adequate and the risks acceptable. The doses are examined, the adverse effects and the importance of the costs is indicated and related with it the supply of Radionuclides. Reference is made so much to the practice of countries developed as to that of countries of smaller resources. It is pointed out the Cuban experience and the perspectives of the use in our country.(author)

  20. Use of radiopharmaceuticals in Finland in 1997

    International Nuclear Information System (INIS)

    Korpela, H.

    1999-04-01

    The use of radiopharmaceuticals in diagnostics and therapy has been surveyed by STUK - Radiation and Nuclear Safety Authority. In 1997 the number of nuclear medicine examinations was 51,700, and the number of treatments 2,240. In 1994 the number of nuclear medicine examinations had been 50,900, and the number of treatments 2,150. In 1997 the collective effective dose received by patients was 207 manSv, and the mean effective dose received by the population was 0.04 mSv per person. In 1994 the collective effective dose had been 220 manSv. Numbers of nuclear medicine examinations and treatments have not changed much from 1994. The collective effective dose has slightly decreased. The main reason for the reduction is decreased use of the radionuclide 131 I. (orig.)

  1. Good practice in the production of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Cruz Arencibia, Jorge

    2012-01-01

    In the paper the evolution of concepts regarding the quality of the pharmaceutical products is analyzed in the framework of the production of radiopharmaceuticals at CENTIS. The world trends range from the quality control of the fi nal product to the comprehensive concept of quality management. It is concluded from the analysis that CENTIS has an appropriate system of Good Manufacturing Practice as a result of 15 years of systematic, growing and qualified attention to the issue, in correspondence with the world tendencies and the continuous support of CECMED, the Cuban regulatory authority. That is certified by the fact that all the production processes of CENTIS have been licensed and all the CENTIS products in the market have been registered. The existing conditions at CENTIS are favorable to establish and certificate a Quality Management System. (author)

  2. Use of radiopharmaceuticals in Finland in 1997

    International Nuclear Information System (INIS)

    Korpela, H.

    1999-02-01

    A survey on the use of radiopharmaceuticals in diagnostics and therapy has been made by STUK Radiation and Nuclear Safety Authority in Finland. In 1997 the number of nuclear medicine examinations was 51 700 and that of the therapeutic treatments was 2 240. In 1994 the number of nuclear medicine examinations was 50 900 and that of therapeutic treatments was 2 150. The collective effective dose to the patients was 207 manSv and the mean effective dose to the population was 0.04 mSv per person. In 1994 the collective effective dose was 220 manSv. The numbers of nuclear medicine examinations and of therapeutic treatments have not changed much when compared to those in 1994. The collective effective dose has decreased. The main reason for that is the decreased use of the radionuclide 131 I. (orig.)

  3. Rationale and radiopharmaceuticals for myocardial imaging

    International Nuclear Information System (INIS)

    Poe, N.D.

    1976-01-01

    Static radionuclide imaging procedures are now available for evaluating regional myocardial perfusion and for detecting acute myocardial infarction. Thallium-201, a radiopharmaceutical which possesses many of the characteristics of potassium analogs, at present is receiving the greatest attention as a regional blood flow indicator. Ischemic lesions appear as areas of decreased tracer uptake. Unfortunately, this agent is expensive, is in limited supply and has a photopeak which is low for optimum imaging. Positive infarct images can be obtained with various technetium-99m chelates. Pyrophosphate appears to be the best of the technetium compounds studied to date although the mechanism of uptake of the chelates has not yet been fully elucidated. Therefore, quantitative measurements of infarct size are not justified. As perfusion imaging and infarct imaging provide useful, complementary data, a dual tracer approach to evaluating patients with suspected coronary artery disease and/or myocardial infarction is probably justifiable

  4. Laboratory methods to evaluate therapeutic radiopharmaceuticals

    International Nuclear Information System (INIS)

    Arteaga de Murphy, C.; Rodriguez-Cortes, J.; Pedraza-Lopez, M.; Ramirez-Iglesias, MT.; Ferro-Flores, G.

    2007-01-01

    The overall aim of this coordinated research project was to develop in vivo and in vitro laboratory methods to evaluate therapeutic radiopharmaceuticals. Towards this end, the laboratory methods used in this study are described in detail. Two peptides - an 8 amino acid minigastrin analogue and octreotate - were labelled with 177 Lu. Bombesin was labelled with 99 mTc, and its diagnostic utility was proven. For comparison, 99 mTc-TOC was used. The cell lines used in this study were AR42J cells, which overexpress somatostatin receptors found in neuroendocrine cancers, and PC3 cells, which overexpress gastric releasing peptide receptors (GRP-r) found in human prostate and breast cancers. The animal model chosen was athymic mice with implanted dorsal tumours of pathologically confirmed cell cancers. The methodology described for labelling, quality control, and in vitro and in vivo assays can be easily used with other radionuclides and other peptides of interest. (author)

  5. Use of radiopharmaceuticals in Finland in 1997

    Energy Technology Data Exchange (ETDEWEB)

    Korpela, H

    1999-04-01

    The use of radiopharmaceuticals in diagnostics and therapy has been surveyed by STUK - Radiation and Nuclear Safety Authority. In 1997 the number of nuclear medicine examinations was 51,700, and the number of treatments 2,240. In 1994 the number of nuclear medicine examinations had been 50,900, and the number of treatments 2,150. In 1997 the collective effective dose received by patients was 207 manSv, and the mean effective dose received by the population was 0.04 mSv per person. In 1994 the collective effective dose had been 220 manSv. Numbers of nuclear medicine examinations and treatments have not changed much from 1994. The collective effective dose has slightly decreased. The main reason for the reduction is decreased use of the radionuclide {sup 131}I. (orig.) 4 refs.

  6. Development of peptide and protein based radiopharmaceuticals.

    Science.gov (United States)

    Wynendaele, Evelien; Bracke, Nathalie; Stalmans, Sofie; De Spiegeleer, Bart

    2014-01-01

    Radiolabelled peptides and proteins have recently gained great interest as theranostics, due to their numerous and considerable advantages over small (organic) molecules. Developmental procedures of these radiolabelled biomolecules start with the radiolabelling process, greatly defined by the amino acid composition of the molecule and the radionuclide used. Depending on the radionuclide selection, radiolabelling starting materials are whether or not essential for efficient radiolabelling, resulting in direct or indirect radioiodination, radiometal-chelate coupling, indirect radiofluorination or (3)H/(14)C-labelling. Before preclinical investigations are performed, quality control analyses of the synthesized radiopharmaceutical are recommended to eliminate false positive or negative functionality results, e.g. changed receptor binding properties due to (radiolabelled) impurities. Therefore, radionuclidic, radiochemical and chemical purity are investigated, next to the general peptide attributes as described in the European and the United States Pharmacopeia. Moreover, in vitro and in vivo stability characteristics of the peptides and proteins also need to be explored, seen their strong sensitivity to proteinases and peptidases, together with radiolysis and trans-chelation phenomena of the radiopharmaceuticals. In vitro biomedical characterization of the radiolabelled peptides and proteins is performed by saturation, kinetic and competition binding assays, analyzing KD, Bmax, kon, koff and internalization properties, taking into account the chemical and metabolic stability and adsorption events inherent to peptides and proteins. In vivo biodistribution can be adapted by linker, chelate or radionuclide modifications, minimizing normal tissue (e.g. kidney and liver) radiation, and resulting in favorable dosimetry analyses. Finally, clinical trials are initiated, eventually leading to the marketing of radiolabelled peptides and proteins for PET/SPECT-imaging and therapy

  7. Preparation and quality control of technetium-99m radiopharmaceuticals

    International Nuclear Information System (INIS)

    Samuels, D.L.

    1978-11-01

    Appropriate procedures for the production and quality control of technetium-99m based radiopharmaceuticals in hospital radiopharmacy consistent with the recently published Australian Code of Good Manufacturing Practice are discussed

  8. Preparation of radiopharmaceutical formulations; Fremstilling av radioaktive farmasoeytiske blandinger

    Energy Technology Data Exchange (ETDEWEB)

    Simon, J.; Garlich, J.R.; Frank, R.K.; McMillan, K

    1998-03-16

    Radiopharmaceutical formulations for complexes comprising at least one radionuclide complexed with a ligand, or its physiologically-acceptable salts thereof, especially {sup 153}samarium-ethylenediaminetetramethylenephosphonic acid, which optionally contains a divalent metal ion, e.g. calcium, and is frozen, thawed, and then administered by injection. Alternatively, the radiopharmaceutical formulations must contain the divalent metal and are frozen only if the time before administration is sufficiently long to cause concern for radiolysis of the ligand. 2 figs., 9 tabs.

  9. Production, control and utilization of radioisotopes including radiopharmaceuticals

    International Nuclear Information System (INIS)

    Muenze, R.

    1985-05-01

    From April 29th to May 5th, 1984 27 participants from 21 developing countries stayed within an IAEA Study Tour ('Production, Control and Utilization of Radioisotopes including Radiopharmaceuticals') in the GDR. In the CINR, Rossendorf the reactor, the cyclotron, the technological centre as well as the animal test laboratory were visited. The participants were made familiar by 10 papers with the development, production and control of radiopharmaceuticals in the CINR, Rossendorf. (author)

  10. Consequences of radiopharmaceutical extravasation and therapeutic interventions: a systematic review

    Energy Technology Data Exchange (ETDEWEB)

    Pol, Jochem van der; Voeoe, Stefan [Maastricht University Medical Centre (MUMC+), Department of Radiology and Nuclear Medicine, Postbox 5800, Maastricht (Netherlands); Bucerius, Jan; Mottaghy, Felix M. [Maastricht University Medical Centre (MUMC+), Department of Radiology and Nuclear Medicine, Postbox 5800, Maastricht (Netherlands); University Hospital, RWTH Aachen University, Department of Nuclear Medicine, Aachen (Germany)

    2017-07-15

    Radiopharmaceutical extravasation can potentially lead to severe soft tissue damage, but little is known about incidence, medical consequences, possible interventions, and effectiveness of these. The aims of this study are to estimate the incidence of extravasation of diagnostic and therapeutic radiopharmaceuticals, to evaluate medical consequences, and to evaluate medical treatment applied subsequently to those incidents. A sensitive and elaborate literature search was performed in Embase and PubMed using the keywords ''misadministration'', ''extravasation'', ''paravascular infiltration'', combined with ''tracer'', ''radionuclide'', ''radiopharmaceutical'', and a list of keywords referring to clinically used tracers (i.e. ''Technetium-99m'', ''Yttrium-90''). Reported data on radiopharmaceutical extravasation and applied interventions was extracted and summarised. Thirty-seven publications reported 3016 cases of diagnostic radiopharmaceutical extravasation, of which three cases reported symptoms after extravasation. Eight publications reported 10 cases of therapeutic tracer extravasation. The most severe symptom was ulceration. Thirty-four different intervention and prevention strategies were performed or proposed in literature. Extravasation of diagnostic radiopharmaceuticals is common. {sup 99m}Tc, {sup 123}I, {sup 18}F, and {sup 68}Ga labelled tracers do not require specific intervention. Extravasation of therapeutic radiopharmaceuticals can give severe soft tissue lesions. Although not evidence based, surgical intervention should be considered. Furthermore, dispersive intervention, dosimetry and follow up is advised. Pharmaceutical intervention has no place yet in the immediate care of radiopharmaceutical extravasation. (orig.)

  11. Radiopharmaceutical regulation and Food and Drug Administration policy.

    Science.gov (United States)

    Rotman, M; Laven, D; Levine, G

    1996-04-01

    The regulatory policy of the Food and Drug Administration (FDA) on radiopharmaceuticals flows from a rigid, traditional, drug-like interpretation of the FDC Act on the licensing of radiopharmaceuticals. This contributes to significant delays in the drug-approval process for radiopharmaceuticals, which are very costly to the nuclear medicine community and the American public. It seems that radiopharmaceuticals would be better characterized as molecular devices. Good generic rule-making principles include: use of a risk/benefit/cost analysis; intent based on sound science; performance standards prepared by outside experts; a definite need shown by the regulatory agency; to live with the consequences of any erroneous cost estimates; and design individual credential requirements so that additional training results in enhanced professional responsibility. When these common elements are applied to current FDA policy, it seems that the agency is out of sync with the stated goals for revitalizing federal regulatory policies as deemed necessary by the Clinton administration. Recent FDA rulings on positron-emission tomography, Patient Package inserts, and on medical device service accentuate the degree of such asynchronization. Radiopharmaceutical review and licensing flexibility could be dramatically improved by excluding radiopharmaceuticals from the drug category and reviewing them as separate entities. This new category would take into account their excellent record of safety and their lack of pharmacological action. Additionally, their evaluation of efficacy should be based on their ability to provide useful scintiphotos, data, or responses of the physiological system it portends to image, quantitate, or describe. To accomplish the goal of transforming the FDA's rigid, prescriptive policy into a streamlined flexible performance-based policy, the Council on Radionuclides and Radiopharmaceuticals proposal has been presented. In addition, it is suggested that the United

  12. Radiopharmaceuticals for cerebral studies; Radiofarmacos para Estudios Cerebrales

    Energy Technology Data Exchange (ETDEWEB)

    Leon Cabana, Alba [Universidad de la Republica, Facultad de Quimica (Uruguay)

    1994-12-31

    For obtain good brain scintillation images in nuclear medicine must be used several radiopharmaceuticals. Cerebral studies give a tumors visual image as well as brain anomalities detection and are helpful in the diagnostic diseases . Are described in this work: a cerebrum radiopharmaceuticals classification,labelled compounds proceeding and Tc 99m good properties in for your fast caption, post administration and blood purification for renal way.

  13. Radionuclide production and radiopharmaceutical chemistry with BNL cyclotrons

    International Nuclear Information System (INIS)

    Lambrecht, R.M.; Wolf, A.P.

    1985-01-01

    The Brookhaven National Laboratory (BNL) radiopharmaceutical chemistry program focuses on production and utilization of radionuclides having a half-life of > 2 hr. However, a major portion of the BNL program is devoted to short-lived radionuclides, such as 11 C and 18 F. Activities encompassed in the program are classified into seven areas: cyclotron parameters, radiochemistry, design and rapid synthesis of radiopharmaceuticals and labeled compounds, radiotracer evaluation in animals, studies in humans, technology transfer, and several other areas

  14. Regulatory requirements for radiopharmaceutical radiochemistry and radiation dosimetry

    International Nuclear Information System (INIS)

    Bonnyman, J.

    1985-01-01

    The Australian Department of Health is responsible for ensuring that radiopharmaceuticals are safe and effective and that their use does not result in unnecessary radiation exposure. Section B1 requirements of New Drug Form 4 (NDF4) fall into the following sections - manufacture, product specifications, quality assurance testing, stability studies and expiry dating. It covers ready to inject pharmaceuticals, radioactive formulations used to prepare a radiopharmaceutical, generators and cold kits

  15. World Radiopharmaceutical Therapy Council: A report on the 5th International Radiopharmaceutical Therapy Colloquium and the Final Planning Meeting of the World Radiopharmaceutical Therapy Council held at Santiago, Chile, 29 September, 2002

    International Nuclear Information System (INIS)

    Turner, J.V.

    2003-01-01

    incorporated body according to a resolution put forward by Henry Wagner and Keith Britton and adopted at the Final Planning Meeting. A final draft of the Charter will be prepared and submitted for ratification at the Establishment Meeting of the World Radiopharmaceutical Therapy Council to be held during the Annual Scientific Meeting of the Society of Nuclear Medicine in New Orleans in June 2003. All physicians, physicists, chemists, oncologists, biological scientists and prospective corporate members, active in the field of therapeutic nuclear medicine, are invited to participate in this global collaborative enterprise to foster worldwide cooperation in research and development and clinical practice of nuclear medicine therapy. (author)

  16. Report on the Technical Meeting on Therapeutic Radiopharmaceuticals

    International Nuclear Information System (INIS)

    2009-01-01

    The purpose of the TM was to provide an experts' platform to facilitate exploring the current status and future directions on therapeutic radiopharmaceuticals. The invited talks and presentations in the TM were in the following topics: - Radionuclide Production; - Production and availability of alpha emitters and their radiopharmaceuticals; - Therapeutic radiopharmaceutical chemistry; - Targets and biological evaluation; - Medical physics and dosimetry; - Clinical applications including radioimmunotherapy and clinical needs; - Peptide receptor mediated therapy Panel discussions: - Radionuclide therapy using alpha emitters; - Regulatory challenges with therapeutic radiopharmaceuticals; - International activities in radionuclide therapy. he technical meeting generated a large interest among scientists and physicians working in the field of targeted therapy using radiopharmaceuticals. Participants from both developed and developing MS reported on recent developments on the research work and clinical studies going on in the field and provided their views on the future developments in this field. The unexpected high number of participants and the high number of presentations with exceptional quality underlines the great interest of scientists and professionals in therapeutic applications using radiolabelled drugs / biomolecules. The intensive discussions including panels specified the challenges in the future on developing novel agents and to finally use them for the benefit of patients. The IAEA can play as vital role in streamlining developments and to provide tools to overcome scientific, professional and regulatory challenges in the field of therapeutic radiopharmaceuticals

  17. Trends in radiopharmaceutical dispensing in a regional nuclear pharmacy

    International Nuclear Information System (INIS)

    Basmadjian, G.P.; Barker, K.; Johnston, J.; Stinchcomb, R.; Tarman, B.; Ice, R.D.

    1983-01-01

    In the last five years, the practice of nuclear medicine has undergone changes due to the advent of new imaging technologies and radiopharmaceuticals. These changes have had an impact upon the number and the type of radiopharmaceuticals dispensed in centralized nuclear pharmacies. With the advent of Computerized Axial Tomography Scanners (CAT), sophistication and wider acceptance of the Ultrasound imaging modality, nuclear medicine has had to change directions from utilizing radiopharmaceuticals for static organ imaging to functional type imaging and to resort to the use of new radiopharmaceuticals or to find other uses for the existing radiopharmaceuticals. The following trends in radiopharmaceutical dispensing in a regional nuclear pharmacy are evident: Brain procedures have declined by about 67% while nuclear cardiology studies have increased by over 2000%. Bone scans have increased by 72% while liver, renal and lung studies have shown no significant increase. These changes will continue as the practice of nuclear medicine concentrates more on functional studies and relegates other studies to newer imaging modalities

  18. Report on the Technical Meeting on Therapeutic Radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-07-01

    The purpose of the TM was to provide an experts' platform to facilitate exploring the current status and future directions on therapeutic radiopharmaceuticals. The invited talks and presentations in the TM were in the following topics: - Radionuclide Production; - Production and availability of alpha emitters and their radiopharmaceuticals; - Therapeutic radiopharmaceutical chemistry; - Targets and biological evaluation; - Medical physics and dosimetry; - Clinical applications including radioimmunotherapy and clinical needs; - Peptide receptor mediated therapy Panel discussions: - Radionuclide therapy using alpha emitters; - Regulatory challenges with therapeutic radiopharmaceuticals; - International activities in radionuclide therapy. he technical meeting generated a large interest among scientists and physicians working in the field of targeted therapy using radiopharmaceuticals. Participants from both developed and developing MS reported on recent developments on the research work and clinical studies going on in the field and provided their views on the future developments in this field. The unexpected high number of participants and the high number of presentations with exceptional quality underlines the great interest of scientists and professionals in therapeutic applications using radiolabelled drugs / biomolecules. The intensive discussions including panels specified the challenges in the future on developing novel agents and to finally use them for the benefit of patients. The IAEA can play as vital role in streamlining developments and to provide tools to overcome scientific, professional and regulatory challenges in the field of therapeutic radiopharmaceuticals

  19. Radiopharmaceutical Stem Cell Tracking for Neurological Diseases

    Directory of Open Access Journals (Sweden)

    Paulo Henrique Rosado-de-Castro

    2014-01-01

    Full Text Available Although neurological ailments continue to be some of the main causes of disease burden in the world, current therapies such as pharmacological agents have limited potential in the restoration of neural functions. Cell therapies, firstly applied to treat different hematological diseases, are now being investigated in preclinical and clinical studies for neurological illnesses. However, the potential applications and mechanisms for such treatments are still poorly comprehended and are the focus of permanent research. In this setting, noninvasive in vivo imaging allows better understanding of several aspects of stem cell therapies. Amongst the various methods available, radioisotope cell labeling has become one of the most promising since it permits tracking of cells after injection by different routes to investigate their biodistribution. A significant increase in the number of studies utilizing this method has occurred in the last years. Here, we review the different radiopharmaceuticals, imaging techniques, and findings of the preclinical and clinical reports published up to now. Moreover, we discuss the limitations and future applications of radioisotope cell labeling in the field of cell transplantation for neurological diseases.

  20. Automation of cells of radiopharmaceuticals production

    International Nuclear Information System (INIS)

    Negrini, Aguinaldo Donizete

    2010-01-01

    The 67 Ga is an important radiopharmaceutical used to identify inflammatory processes in chronic illnesses, diagnosis by image of tumors in soft tissues and the possibility to evaluate the result for therapeutic intervention. In the present work a module of 67 Ga processing was developed with the objective to reduce the interventions in the hot cell, in order to avoid oxidation caused by metallic materials, and consuming in hoses of the peristaltic pumps, that release residues that blocked the valves used in the process. With materials such as: acrylic, PVC, PEEK e teflon and they are used vacuum as method (way) of fluid transferences instead of peristaltic pump in the majority of the procedures, with this improvements the system can make shorter the lengths of transference hoses, increasing the yield in the process with less interventions for maintenance and time exposure of the workers, guaranteeing the quality and reducing the time of the processing. using a mobile system for displacement of the processing module making in the cleanness and maintenance of the cell that works with radioactive material. Reducing the time of exposure dose of the workers in compliance with RDC-17 of ANVISA, which ruling the Good Manufacturing Practice Procedures. (author)

  1. Drug interaction with radiopharmaceuticals: a review

    International Nuclear Information System (INIS)

    Bernardo-Filho, Mario; Santos-Filho, Sebastiao David; Moura, Egberto Gaspar de; Maiworm, Adalgisa Ieda; Bernardo, Luciana Camargo; Brito, Lavinia de Carvalho; Orlando, Margarida Maria de Camoes; Penas, Maria Exposito; Cardoso, Valbert Nascimento

    2005-01-01

    Clinical images are worthwhile in Health Sciences and their analysis and correct interpretation aid the professionals,such as physicians, physiotherapists and occupational therapists, to make decisions and take subsequent therapeutic and/or rehabilitation measures. Other factors, besides the state of the disease, may interfere and affect the bioavailability of the radiopharmaceuticals (radiobiocomplexes) and the quality of the SPECT and PET images. Furthermore, the labeling of some of these radiobiocomplexes, such as plasma proteins, white blood cells and red blood cells, with 99m T, can also be modified. These factors include drugs (synthetic and natural) and dietary conditions, as well as some medical procedures (invasive or non-invasive), such as radiation therapy, surgical procedures, prostheses, cardioversion, intubation, chemo perfusion, external massage, immunotherapy, blood transfusion and hemodialysis. In conclusion, the knowledge about these factors capable of interfering with the bioavailability of the radiobiocomplexes is worthwhile for secure diagnosis. Moreover, the development of biological models to study these phenomena is highly relevant and desirable.(author)

  2. Role of radiopharmaceuticals in detection of osteomyelitis

    International Nuclear Information System (INIS)

    Mack, J.M.; Spencer, R.P.

    1990-01-01

    Osteomyelitis can present as a significant diagnostic problem in medicine. Knowledge of the presence and extent of infection involving bone is important in determining treatment. In this paper the authors review the role played by radiopharmaceutical techniques in establishing the diagnosis of osteomyelitis. Osteomyelitis has been recognized as one of the most serious complications of emergency surgery to repair severe bone trauma. It is also a complication of surgery for prosthesis placement. In still other instances, osteomyelitis can be of hematogenous origin, without a major wound site. Unlike other infections, it rarely presents with acute symptoms. Osteomyelitis is divided into two categories that are time related: acute, in which clinical signs and symptoms of bone infection have been present for less than 1 month, and chronic, in which symptoms have been present for more than 1 month. The acute type is usually caused by Staphylococcus aureus in children (often secondary to skin infection), whereas in adults it can be secondary to intravenous drug abuse. Predisposing factors such as diabetes mellitus, peripheral vascular disease, and sickle cell disease are important to the outcome of osteomyelitis. One way to determine the microbe causing the infection is direct bone biopsy from the site of suspected osteomyelitis. There is one important limitation for needle biopsy in the diagnosis of osteomyelitis. Biopsies are contraindicated in the small bones of the hands and feet, because of risk of pathologic fracture (and may be relatively contraindicated after diphosphonate therapy and loss of bone mineral)

  3. Rhenium radioisotopes for therapeutic radiopharmaceutical development

    International Nuclear Information System (INIS)

    Knapp, F.F. Jr.; Beets, A.L.; Pinkert, J.; Kropp, J.; Lin, W.Y.; Wang, S.Y.

    2001-01-01

    Rhenium-186 and rhenium-188 represent two important radioisotopes which are of interest for a variety of therapeutic applications in oncology, nuclear medicine and interventional cardiology. Rhenium-186 is directly produced in a nuclear reactor and the 90 hour half-life allows distribution to distant sites. The relatively low specific activity of rhenium-186 produced in most reactors, however, permits use of phosphonates, but limits use for labelled peptides and antibodies. Rhenium-188 has a much shorter 16.9 hour half-life which makes distribution from direct reactor production difficult. However, rhenium-188 can be obtained carrier-free from a tungsten-188/rhenium-188 generator, which has a long useful shelf-life of several months which is cost-effective, especially for developing regions. In this paper we discuss the issues associated with the production of rhenium-186- and rhenium-188 and the development and use of various radiopharmaceuticals and devices labelled with these radioisotopes for bone pain palliation, endoradiotherapy of tumours by selective catheterization and tumour therapy using radiolabelled peptides and antibodies, radionuclide synovectomy and the new field of vascular radiation therapy. (author)

  4. Application of lectins to tumor imaging radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kojima, Shuji; Jay, M.

    1986-01-01

    We investigated the in vitro binding of 125 I-lectins to Ehrlich ascites tumor (EAT) cells and in vivo uptake of 125 I-lectins in Ehrlich solid tumor (EST) bearing mice. In in vitro binding assays, phaseolus vulgaris agglutinin (PHA), pisum sativum agglutinin (PSA), and concanavalia agglutinin (Con A) showed a high affinity for EAT cells. The in vivo biodistribution of 125 I-lectins showed 125 I-PSA to be significantly taken up into EST tissues 24 h postinjection. After IV injection of 125 I-PSA, uptake of the radioactivity into the tumor tissues reached a maximum at 6 h, and thereafter decreased. Rapid disappearance of the radioactivity from blood and its excretion into kidney soon after injection of 125 I-PSA were observed. When compared with the biodistribution of 67 Ga-citrate in EST bearing mice 24 h postinjection, tumor to liver (T/B), tumor to muscle (T/M), and tumor to blood (T/B) ratios were superior for 125 I-PSA. At 6 h postinjection, the T/B-ratio of 125 I-PSA was 2.5, and this value may be sufficient to enable discernable diagnostic images. Our results suggest that PSA might be a useful tumor imaging radiopharmaceutical. (orig.)

  5. Absolute counting of 188Re radiopharmaceuticals

    International Nuclear Information System (INIS)

    Ravindra, Anuradha; Kulkarni, D.B.; Joseph, Leena; Kulkarni, M.S.

    2018-01-01

    Rhenium-188 is radiopharmaceutical that belongs to the group of strong beta-weak gamma emitters. It emits high energy beta particles, (E β m ax = 2.12MeV) and weak gamma rays (E γ = 155 keV) hence makes it suitable for wide variety of therapeutic as well as diagnostic applications. Therapeutic applications include therapy of tumors, radionuclide synovectomy, bone pain palliation, intra vascular radiation therapy etc. 188 Re-labeled medicines have been employed increasingly in the therapy of tumors and vascular restenosis. To ensure that patient receives the appropriate radiation dose during the treatment, both the activity standardization and the determination of sensitivity coefficient of the secondary standard for 188 Re have become important tasks. This paper presents the methods and results obtained for the following measurements a) Standardisation of the 188 Re by using the 4π proportional counter (4πPC)-gamma extrapolation method b) Determination of sensitivity coefficient (pA/MBq) of the secondary standard ionization chamber type Centronic IG12, 20A for 188 Re

  6. Manufacturing on the radiopharmaceuticals produced by cyclotron

    International Nuclear Information System (INIS)

    Ueda, Nobuo

    1994-01-01

    Radiopharmaceutical (RP) produced by cyclotrons are widely used for the in vivo diagnosis of various diseases such as cancer, cerebral vascular disorders and cardiac diseases. The nuclides used as RPs and their nuclear reactions, and the quantity of RPs supplied in Japan in the last five years are shown. These RPs are delivered to about 1,100 hospitals in Japan. Thallium-201 and iodine-123 showed very high growth rate. Recently, two new I-123 RPs, BMIPP and MIBG which are heart-imaging agents, have been supplied. It suggests that the quantity of I-123 will increase much more in future. The image diagnostic method using RPs is called in vivo nuclear medicine, and has become the indispensable means for medical institutions together with X-ray CT, nuclear magnetic resonance imaging and ultrasonic diagnosis. The RPs for in vivo diagnosis generally used at present are classified into those labeled with the RIs produced with cyclotrons and those labeled with Tc-99m formed by the decay of Mo-99. The quantity being used is overwhelmingly more in the latter, but the former shows the tendency of growth. The commercial production of cyclotron RIs for medical use, the chemical forms and the diagnostic purposes of the RPs using cyclotron RIs, and the state of use of the cyclotron-produced RPs are reported. (K.I.)

  7. Development of radiopharmaceuticals and industrial constraints

    International Nuclear Information System (INIS)

    Zimmermann, R.

    2005-01-01

    The development process of a diagnostic or therapeutic radiopharmaceutical does not really differ from the development of a classical drug. Some specific properties of these nuclear medicine tools mainly linked to the ease to follow their distribution in the human body allow to save a couple of years out of the dozen of years required to bring a drug on the market. Overall development costs can be significantly reduced for the same reason. An industrial who wants to invest in such a business bases its analysis on other criteria that need to evaluate the medical, safety and regulatory environment at the time of drug launching. Competition is obviously a major decision criteria, but in order to evaluate the market potential, other data must be available such as the analysis of the medical landscape, the reimbursement issues, the technology evolution, the investment needs or the development of other imaging modalities, among others. In fact all these parameters concentrate toward a common criteria, the profitability of the project. Nuclear medicine moved from an art and crafts era towards the industrial era and hence plunged from the twentieth to the twenty first century in the economic reality with all its constraints and consequences. (author)

  8. Traceability in the pharmaceutical industry: application to radiopharmaceutical production

    International Nuclear Information System (INIS)

    Zanette, Camila; Melero, Laura T.U.H.; Araujo, Elaine B. de; Mengatti, Jair; Silva, Katia S. de S.

    2011-01-01

    The development of tools to promote the traceability of the drugs in the pharmaceutical industry during all the production chain is a necessary requisite. The traceability system is applied to enable the identification of the origin, destination and exact location of the drug. Traceability optimizes the process chain, reduces errors, is a requirement for quality process, promotes safety for the user and assists in pharmacovigilance. The health regulatory agency in Brazil (ANVISA) will implement a tracking system for medicaments with RDC no. 59 of 2009, to control distribution since the producer until the patients in order to prevent the traffic and adulteration of drugs. Thus, this study discusses the importance and impact of the new traceability system proposed by ANVISA in the production and distribution of radiopharmaceuticals from the Nuclear and Energy Research Institute (IPEN-CNEN). The radiopharmaceuticals have a difference track when compared with another drug classes. In this context, this RDC would increase the price of the medicines by up to 10%, since it provides deployment of a single stamp supplied by the Mint. Considering that radiopharmaceuticals are not sold to the final consumer (patients), but only for accredited medical clinics and nuclear medicine physicians, and the transport of radiopharmaceuticals is performed by specialized companies licensed by CNEN (National Nuclear Energy Commission), the use of the stamp to ensure authenticity and prevent falsification should not be appropriated and represents and additional cost for the radiopharmaceuticals. (author)

  9. Aptamers as radiopharmaceuticals for nuclear imaging and therapy

    International Nuclear Information System (INIS)

    Gijs, Marlies; Aerts, An; Impens, Nathalie; Baatout, Sarah; Luxen, André

    2016-01-01

    Today, radiopharmaceuticals belong to the standard instrumentation of nuclear medicine, both in the context of diagnosis and therapy. The majority of radiopharmaceuticals consist of targeting biomolecules which are designed to interact with a disease-related molecular target. A plethora of targeting biomolecules of radiopharmaceuticals exists, including antibodies, antibody fragments, proteins, peptides and nucleic acids. Nucleic acids have some significant advantages relative to proteinaceous biomolecules in terms of size, production, modifications, possible targets and immunogenicity. In particular, aptamers (non-coding, synthetic, single-stranded DNA or RNA oligonucleotides) are of interest because they can bind a molecular target with high affinity and specificity. At present, few aptamers have been investigated preclinically for imaging and therapeutic applications. In this review, we describe the use of aptamers as targeting biomolecules of radiopharmaceuticals. We also discuss the chemical modifications which are needed to turn aptamers into valuable (radio-)pharmaceuticals, as well as the different radiolabeling strategies that can be used to radiolabel oligonucleotides and, in particular, aptamers.

  10. Auger Emitting Radiopharmaceuticals for Cancer Therapy

    Science.gov (United States)

    Falzone, Nadia; Cornelissen, Bart; Vallis, Katherine A.

    Radionuclides that emit Auger electrons have been of particular interest as therapeutic agents. This is primarily due to the short range in tissue, controlled linear paths and high linear energy transfer of these particles. Taking into consideration that ionizations are clustered within several cubic nanometers around the point of decay the possibility of incorporating an Auger emitter in close proximity to the cancer cell DNA has immense therapeutic potential thus making nuclear targeted Auger-electron emitters ideal for precise targeting of cancer cells. Furthermore, many Auger-electron emitters also emit γ-radiation, this property makes Auger emitting radionuclides a very attractive option as therapeutic and diagnostic agents in the molecular imaging and management of tumors. The first requirement for the delivery of Auger emitting nuclides is the definition of suitable tumor-selective delivery vehicles to avoid normal tissue toxicity. One of the main challenges of targeted radionuclide therapy remains in matching the physical and chemical characteristics of the radionuclide and targeting moiety with the clinical character of the tumor. Molecules and molecular targets that have been used in the past can be classified according to the carrier molecule used to deliver the Auger-electron-emitting radionuclide. These include (1) antibodies, (2) peptides, (3) small molecules, (4) oligonucleotides and peptide nucleic acids (PNAs), (5) proteins, and (6) nanoparticles. The efficacy of targeted radionuclide therapy depends greatly on the ability to increase intranuclear incorporation of the radiopharmaceutical without compromising toxicity. Several strategies to achieve this goal have been proposed in literature. The possibility of transferring tumor therapy based on the emission of Auger electrons from experimental models to patients has vast therapeutic potential, and remains a field of intense research.

  11. Molecular target in oncology. Opportunity for radiopharmaceuticals development

    International Nuclear Information System (INIS)

    Navarro Marques, Fabio Luiz

    2016-01-01

    Cancer is a cellular multifactorial disease, regulated by changes in phenotype characteristics, such as adhesion, invasion, migration, and tumorigenesis; genotypic status of commonly altered genes (KRAS and p53); microenvironmental conditions, such pH, oxygen and nutrient supply. All these features provide opportunities for radiopharmaceuticals development, both for diagnostic and therapy. For both applications, radiopharmaceuticals molecules can be divided in small synthetic molecules, small peptides (natural or modified), large molecules such as antibody or nanoparticles. The characteristics of those molecules and use will guide the choice of the radionuclide to be used for labeling it. In the presentation, data from literature and research ongoing in the Faculty of Medicine of the University of São Paulo/Brazil will be used for demonstrate the potential for radiopharmaceuticals development. (author)

  12. Ensuring quality while going local: IAEA helps Cuba produce radiopharmaceuticals

    International Nuclear Information System (INIS)

    Jawerth, Nicole

    2015-01-01

    Cancer and cardiovascular disease are health conditions Cuba will now be able to more readily diagnose and treat thanks to its newly built facility for producing key radiopharmaceuticals. Nuclear medicine requires a constant and reliable supply of these radioactive drugs, prepared according to what the industry calls good manufacturing practices (GMP), and there have so far been limitations in getting them to the island nation. “Through our work with the IAEA, we now have a dedicated GMP compliant facility and the expertise to meet most of our national needs for diagnostic and therapeutic radiopharmaceuticals for helping patients,” said René Leyva Montaña, Director of Production at the Isotope Centre (CENTIS), Cuba’s centre dedicated to radiopharmaceutical production.

  13. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 2000

    International Nuclear Information System (INIS)

    Johannsen, B.; Seifert, S.

    2001-01-01

    In 2000 the Rossendorf research centre continued and further developed its basic and application-oriented research. Research at the Institute of Bioinorganic and Radiopharmaceutical Chemistry, one of five institutes in the Research Centre, was focused on radiotracers as molecular probes to make the human body biochemically transparent with regard to individual molecular reactions. In this respect the potential for diagnostic application depends on the quality and versatility of radiopharmaceutical chemistry, which is the main discipline in our Institute. Areas in which the Institute was particularly active were the design of new radiotracers, both radiometal-based and natural organic molecules, the elaboration of radiolabelling concepts and procedures and the chemical and pharmacological evaluation of new tracers. This was complemented by more clinically oriented activities in the Positron Emission Tomography Centre Rossendorf. With numerous contributions in the fields of radiopharmaceutical chemistry, tumour agents, tumour diagnosis and brain biochemistry this Annual Report will document the scientific progress made in 2000. (orig.)

  14. Radiation Protection, double-blind studies with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Pujadas, M. C.; Camacho, C.; Guasp, M.; Villaescusa, J. I.

    2009-01-01

    In a double-blind randomized controlled clinical trial (RCT) subjects and researchers do not know the assignment to treatment groups to ovoid the appearance of subjective biases of information. The employment of radiopharmaceuticals in double-blind RCTs raises a dilemma from the point ov view of the radiological protection. On the one hand, the obligation to act in cases of contamination and/or risk of irradiation exists, but on the other hand the duty of keeping the blind study also exists. In this paper some of the possible problems that arise when conducting a double-blind RCT with radiopharmaceuticals from the point of view of the radiological protection are presented. We comment our experience with the radiopharmaceutical Alpharadin and, in addition, we propose useful recommendations based on the randomness of the decontamination process. (Author) 7 refs.

  15. Design of GMP compliance radiopharmaceutical production facility in MINT

    International Nuclear Information System (INIS)

    Anwar Abd Rahman; Shaharum Ramli; M Rizal Mamat Ibrahim; Rosli Darmawan; Yusof Azuddin Ali; Jusnan Hashim

    2005-01-01

    In 1985, MINT built the only radiopharmaceutical production facility in Malaysia. The facility was designed based on IAEA (International Atomic Energy Agency) standard guidelines which provide radiation safety to the staff and the surrounding environment from radioactive contamination. Since 1999, BPFK (Biro Pengawalan Farmaseutikal Kebangsaan) has used the guidelines from Pharmaceutical Inspection Convention Scheme (PICS) to meet the requirements of the Good Manufacturing Practice (GMP) for Pharmaceutical Products. In the guidelines, the pharmaceutical production facility shall be designed based on clean room environment. In order to design a radiopharmaceutical production facility, it is important to combine the concept of radiation safety and clean room to ensure that both requirements from GMP and IAEA are met. The design requirement is necessary to set up a complete radiopharmaceutical production facility, which is safe, has high production quality and complies with the Malaysian and International standards. (Author)

  16. Knowledge-based automated radiopharmaceutical manufacturing for Positron Emission Tomography

    International Nuclear Information System (INIS)

    Alexoff, D.L.

    1991-01-01

    This article describes the application of basic knowledge engineering principles to the design of automated synthesis equipment for radiopharmaceuticals used in Positron Emission Tomography (PET). Before discussing knowledge programming, an overview of the development of automated radiopharmaceutical synthesis systems for PET will be presented. Since knowledge systems will rely on information obtained from machine transducers, a discussion of the uses of sensory feedback in today's automated systems follows. Next, the operation of these automated systems is contrasted to radiotracer production carried out by chemists, and the rationale for and basic concepts of knowledge-based programming are explained. Finally, a prototype knowledge-based system supporting automated radiopharmaceutical manufacturing of 18FDG at Brookhaven National Laboratory (BNL) is described using 1stClass, a commercially available PC-based expert system shell

  17. Quality assurance of radiopharmaceuticals - specifications and test procedures

    International Nuclear Information System (INIS)

    Baldas, J.; Bonnyman, J.; Colmanet, S.F.; Ivanov, Z.; Lauder, R.A.

    1990-10-01

    The authors report on a Radiopharmaceutical Quality Assurance Test Programme carried out by the Australian Radiation Laboratory in which radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications. Where the radiopharmaceutical is the subject of a monograph in the British Pharmacopoeia or the European Pharmacopoeia, then the specifications given in the Pharmacopoeia are adopted. In other cases the specifications given have been adopted by this Laboratory and have no legal status. In some cases test procedures described have been taken from various Pharmacopoeias or methods published in the literature. In other cases test methods described have been developed at this Laboratory. It should be noted that, unless stated otherwise, specifications listed apply at all times up until product expire

  18. Analytical techniques for the determination of radiochemical purity of radiopharmaceuticals prepared from kits. Part II

    International Nuclear Information System (INIS)

    MacLean, J.R.; Rockwell, L.J.; Welsh, W.J.

    The evaluation of efficacy of commercially available kits used for the preparation of radiopharmaceuticals is one aspect of the Radiation Protection Bureau's radiopharmaceutical quality control program. This report describes some of the analytical methodology employed in the program. Many of the tests can be performed rapidly and with a minimum of special equipment, thus enabling the confirmation of radiopharmaceutical purity prior to patient administration

  19. Recent developments in the field of 123I-radiopharmaceuticals

    International Nuclear Information System (INIS)

    Machulla, H.J.; Knust, E.J.

    1984-01-01

    Due to its advantageous nuclear physical properties iodine-123 is an excellent label for radiopharmaceuticals very well suited for measurements by γ-cameras and single-photon emission tomography. The development of 123 I-radiopharmaceuticals should be based on a clear biochemical concept, reliable labelling procedures and careful pharmacokinetic studies in order to evaluate the physiological behaviour of the radioiodinated compounds being analogues of metabolic substrates. The development of 123 I-labelled fatty acids and biogenic amines clearly proved the successful use of 123 I for labelling compounds applied in medical diagnosis. (orig.) [de

  20. EEC directives and guidelines applicable to radiopharmaceuticals - 1993

    International Nuclear Information System (INIS)

    Cox, P.H.

    1993-01-01

    The manufacture, scale and supply of radiopharmaceuticals in the EEC is regulated by directives that are incorporated into the national laws of the member states. The situation as of 1 January 1993 was not too optimistic, however, as the processing of licensing applications had been completely misjudged. Not one product had been registered as of 1 January. The costs involved are also high and since the European market for radiopharmaceuticals is relatively small, the market cannot afford this. It would appear that the EEC directives are inadquate and too non-specific, so revision is indicated. (orig.)

  1. The transport of radiopharmaceuticals in the United States

    Energy Technology Data Exchange (ETDEWEB)

    Ferate, F.D. [U. S. Dept. of Transportation, Washington, DC (United States)

    2004-07-01

    Among all the various uses of radioactive materials for peaceful purposes, the creation and use of radiopharmaceuticals to diagnose and treat medical ailments has probably brought the greatest benefit to humanity. The use of radionuclides in medicine has mushroomed over the past 20 years, as has the number of nuclides and procedures which are now routinely used in hospitals and clinics around the globe. Parallel to the growth in the use of radiopharmaceuticals has been the growth in shipments of these nuclides and their compounds to the locations where they are used.

  2. The transport of radiopharmaceuticals in the United States

    International Nuclear Information System (INIS)

    Ferate, F.D.

    2004-01-01

    Among all the various uses of radioactive materials for peaceful purposes, the creation and use of radiopharmaceuticals to diagnose and treat medical ailments has probably brought the greatest benefit to humanity. The use of radionuclides in medicine has mushroomed over the past 20 years, as has the number of nuclides and procedures which are now routinely used in hospitals and clinics around the globe. Parallel to the growth in the use of radiopharmaceuticals has been the growth in shipments of these nuclides and their compounds to the locations where they are used

  3. New radiopharmaceuticals currently used in clinical nuclear medicine

    International Nuclear Information System (INIS)

    Hladik, W.B. III

    1997-01-01

    During 1996 and 1997, six new radiopharmaceuticals have been approved by the U.S. Food and Drug Administration for use in the diagnosis and/or management of patients with various disease states. Four of these new agents are antibody-based diagnostic radiotracers, and one is a therapeutic agent. One radio-pharmaceutical that has been available for several years has been approved for a new, unique indication. Our discussion focuses on the physicochemical and pharmacokinetic properties of these recently released agents as well as their specific role in the management of patients

  4. A short history of radiopharmaceutical research in Australia

    International Nuclear Information System (INIS)

    Baker, R.

    1989-01-01

    A brief summary is given of radiopharmaceuticals research carried out in Australia. Historically, a number of the larger hospital radiopharmacies have been, and still are, involved with 99m Tc-cold kit production. Originally, this scenario evolved because the nuclear medicine community was denied access to state-of-the-art products available overseas. Although the situation has improved in recent times, most such departments continue kit production, having made a large capital investment in sterile facilities, equipment and staff. Australian Nuclear Science and Technology Organization has a leading role in radiopharmaceutical research and some of the topics which have occupied its scientists over the last few years are outlined

  5. Depyrogenation, sterilization and deproteination of radiopharmaceuticals with an ultrafilter

    Energy Technology Data Exchange (ETDEWEB)

    Suzuki, K; Tamate, K; Nakayama, T [National Inst. of Radiological Sciences, Chiba (Japan)

    1984-01-01

    A newly developed filter holder is described for an ultrafiltration method used in the removal of pyrogen, enzyme and bacteria in the preparation of intravenously injectable radiopharmaceuticals. Penetration ratios of bovine serum albumin, glutamate dehydrogenase and Escherichia coli endotoxin through the PTGC ultrafilter (NMWL = 10,000) were measured; these results are useful for estimating penetration ratios of other macromolecules. Attempts to obtain i.v. injectable /sup 13/NH, L- /sup 13/N-glutamate and 3- /sup 123/I-iodotyrosine radiopharmaceuticals were successful; after ultrafiltration, pyrogen, bacteria or protein were not detected.

  6. Stannous ion determination in99mTc - radiopharmaceutical kits

    International Nuclear Information System (INIS)

    Almeida, M.A.T.M. de; Silva, C.P.G. da.

    1989-10-01

    Two simple and selective methods for determination of stannous ion in radiopharmaceutical kits are proposed. One of this permits the estimation of stannic ion. The first method used is a potentiometric tiration of Sn +2 in HCl medium using KIO 3 solution under nitrogen gas and a redox platinum electrode. The second method consist of a compleximetric tiration of tin (Sn +2 and Sn +4 ) using EDTA standart solution at pH 5.5-5.6 without use of nitrogen gas. The employed procedures indicates that both the methods can be used for routine quantitative determination of tin in most labeled radiopharmaceuticals. (author) [pt

  7. Which radiopharmaceuticals for to-morrow. Heart and brain investigations

    International Nuclear Information System (INIS)

    Maziere, B.

    1994-01-01

    This paper is a critical review of the various radiopharmaceuticals which have been or are presently designed for functional imaging of brain or heart using positron (PET) or single photon emission tomography. Currently used radiopharmaceuticals have been classified into two broad categories: 'passive' radiotracers intended to visualize the perfusion of the organ and 'active' or 'specific' radiotracers used to investigate metabolism or neurotransmission processes. Moreover, the potential interest of radioactive peptides or oligonucleotides which would be biologically stable in vivo and which could target proteins involved in inter or intra-cellular communications will be reviewed. (authors). 47 refs

  8. Effects of radiation exposure from radiopharmaceuticals used in diagnostic studies

    International Nuclear Information System (INIS)

    Witcofski, R.L.

    1981-01-01

    In the United States about 90 percent of man-made radiation exposure to the general population is from the use of radiation in diagnostic medicine. Although the doses of radiation from these procedures to individuals are generally quite small, large numbers of people are exposed. Estimates of the radiation doses associated with such use in the healing arts are approximately 15 million person-rem to the general population from diagnostic x ray and 3.3 million person-rem from the diagnostic use of radiopharmaceuticals. The purpose of this paper is to present what is known about the possible effects of radiation from diagnostic radiopharmaceuticals

  9. Design of radiopharmaceuticals for monitoring gene transfer therapy

    International Nuclear Information System (INIS)

    Lambrecht, R.M.; Staehler, P.; Kley, J.; Spiegel, M.; Gross, C.; Graepler, F.T.C.; Gregor, M.; Lauer, U.; Oberdorfer, F.

    1998-01-01

    The development of radiopharmaceuticals for monitoring gene transfer therapy with emission tomography is expected to lead to improved management of cancer by the year 2010. There are now only a few examples and approaches to the design of radiopharmaceuticals for gene transfer therapy. This paper introduces a novel concept for the monitoring of gene therapy. We present the optimisation of the labelling of recombinant human β-NGF ligands for in vitro studies prior to using 123 I for SPET and 124 I for PET studies. (author)

  10. Drug interaction with radiopharmaceuticals: a review

    Directory of Open Access Journals (Sweden)

    Mario Bernardo-Filho

    2005-10-01

    Full Text Available Clinical images are worthwhile in Health Sciences and their analysis and correct interpretation aid the professionals,such as physicians, physiotherapists and occupational therapists, to make decisions and take subsequent therapeutic and/or rehabilitation measures. Other factors, besides the state of the disease, may interfere and affect the bioavailability of the radiopharmaceuticals (radiobiocomplexes and the quality of the SPECT and PET images. Furthermore, the labeling of some of these radiobiocomplexes, such as plasma proteins, white blood cells and red blood cells, with 99mT, can also be modified. These factors include drugs (synthetic and natural and dietary conditions, as well as some medical procedures (invasive or non-invasive, such as radiation therapy, surgical procedures, prostheses, cardioversion, intubation, chemoperfusion, external massage, immunotherapy, blood transfusion and hemodialysis. In conclusion, the knowledge about these factors capable of interfering with the bioavailability of the radiobiocomplexes is worthwhile for secure diagnosis. Moreover, the development of biological models to study these phenomena is highly relevant and desirable.Imagens clínicas são valiosas em Ciências da Saúde e a análise e a interpretação correta das mesmas auxiliam os profissionais, como médico, fisioterapeuta, terapeuta ocupacional, na tomada de decisões e subseqüentes ações terapêuticas e/ou de reabilitação. Além das doenças outros fatores podem interferir e afetar a biodisponibilidade dos radiofármacos (radiobiocomplexos e a qualidade das imagens (SPECT e PET. Além disso, a marcação de alguns desses radiobiocomplexos com Tc-99m, como proteínas plasmáticas, leucócitos e hemácias, também pode ser modificada. Entre esses fatores, estão drogas (sintéticas e naturais e condições alimentares, assim como alguns procedimentos médicos (invasivos e não invasivos, como a radioterapia, processos cirúrgicos, pr

  11. Radiopharmaceuticals for diagnosis and therapy of cancer

    International Nuclear Information System (INIS)

    Wiebe, L.I.

    1998-01-01

    This paper addresses the utilization of three very distinct enzyme systems for imaging in oncology. The first of these is an enzyme encoded by a viral gene that is not present in non-infected mammalian cells. This enzyme is a nucleoside kinase that converts selected unnatural nucleosides to nucleotides in virus-infected or gene-transfected cells, but not in normal cells. The most commonly used viral kinase in gene therapy today is Herpes simplex virus type-1 thymidine kinase (HSV tk). The imaging applications of this gene therapy system are demonstrated using data from a murine tumour gene therapy model, with 123 IVFRU as the diagnostic radiopharmaceutical. The second enzyme system is endogenous to mammalian cells, but is found in highest concentrations in tissues of neutral crest derivation. The overall biochemical pathway of interest involves the conversion of tyrosine to either dopamine (neurotransmitter pathway), or to melanin (pigmentation pathway). In this system tyrosinase is the 'branching' enzyme, converting dopa to dopaquinone, thereby averting its conversion to dopamine. With selective agents, the tracer can be trapped in this 'melanin pathway', which is particularly active in melanomas. Data on the development of radioiodinated tyrosinase substrates, based on S-cysteaminyl phenol (SCAP), a highly specific tyrosinase substrate, are presented to illustrate this concept. The final example is that of endogenous enzymes that are virtually ubiquitous in biodistribution. One class of enzymes, the reductases, are particularly active in the liver and their activity is amplified in tissues that are hypoxic. They are important in radiotherapy, where they can be utilized to bioreductively activate compounds that can restore the radiosensitivity of hypoxic cells. The 2-nitroimidazoles are of special interest because they are easily reducible by a number of reductases, a process that is made selective by the reversibility of reduction in the presence of cellular

  12. Kinetic model for the dosimetry of radiopharmaceuticals contaminated by Mo-99

    International Nuclear Information System (INIS)

    Shearer, D.R.; Pezzullo, J.C.

    1986-01-01

    Radiopharmaceuticals tagged with Tc-99m may become contaminated with breakthrough products from the Mo-99/Tc-99m generator. If a fraction of the contaminant becomes bound to the radiopharmaceutical, the dose to the radiopharmaceutical target organ from the contaminant must be considered. The dose to the contaminant target organ may then be calculated as the sum of the doses from a) the initially unbound contaminant, and b) the contaminant later released by degradation of the radiopharmaceutical. This paper presents a model which takes the above processes into account. The model is illustrated with clinical data derived from Mo-99 contaminated radiopharmaceuticals. 5 references, 2 figures, 6 tables

  13. Intergrated approach to quality control procedures of radioisotopes and radiopharmaceuticals

    International Nuclear Information System (INIS)

    Rohani Mohamad

    1986-01-01

    Various aspects of the quality control procedures for radioisotopes and radiopharmaceuticals have been discussed. The paper high lighted those procedures that are important in ensuring the efficacy of the product. It also gives a general idea of the various procedures that are actually carried out by the Quality Control Section. (A.J.)

  14. WIPR 2013 - Radiopharmaceuticals: from research to industry - Book of abstracts

    International Nuclear Information System (INIS)

    2015-01-01

    This workshop aims at presenting the latest progress in the field of radioimmunotherapy: radiopharmaceutical production, radiochemistry, radiolabelling, nuclear imaging and clinical applications. The presentations have been divided into 4 sessions: 1) alpha or beta radioimmunotherapy, 2) peptides or antibodies, 3) the benefits from nuclear imaging, and multimodal imaging

  15. Influence of sweeteners in the biodistribution of radiopharmaceutical ...

    African Journals Online (AJOL)

    Influence of sweeteners in the biodistribution of radiopharmaceutical and laboratory tests in rats. Michelly Pires Queiroz, Vanessa Santos de Arruda Barbosa, Cecília Maria de Carvalho Xavier Holanda, Janette Monroy Osório, Tarciso Bruno Montenegro Sampaio, Christina da Silva Camillo, Aldo Cunha Medeiros, Marília ...

  16. Guidance for nuclear medicine staff on radiopharmaceuticals drug interaction

    International Nuclear Information System (INIS)

    Santos-Oliveira, Ralph

    2009-01-01

    Numerous drug interactions related to radiopharmaceuticals take place every day in hospitals many of which are not reported or detected. Information concerning this kind of reaction is not abundant, and nuclear medicine staff are usually overwhelmed by this information. To better understand this type of reaction, and to help nuclear medicine staff deal with it, a review of the literature was conducted. The results show that almost all of radiopharmaceuticals marketed around the world present drug interactions with a large variety of compounds. This suggests that a logical framework to make decisions based on reviews incorporating adverse reactions must be created. The review also showed that researchers undertaking a review of literature, or even a systematic review that incorporates drug interactions, must understand the rationale for the suggested methods and be able to implement them in their review. Additionally, a global effort should be made to report as many cases of drug interaction with radiopharmaceuticals as possible. With this, a complete picture of drug interactions with radiopharmaceuticals can be drawn. (author)

  17. Harvard-MIT research program in short-lived radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Adelstein, S.J.

    1991-01-01

    This report presents research on radiopharmaceuticals. The following topics are discussed: antibody labeling with positron-emitting radionuclides; antibody modification for radioimmune imaging; labeling antibodies; evaluation of technetium acetlyacetonates as potential cerebral blood flow agents; and studies in technetium chemistry. (CBS)

  18. Cyclotron targets and production technologies used for radiopharmaceuticals in NPI

    Czech Academy of Sciences Publication Activity Database

    Fišer, Miroslav; Kopička, Karel; Hradilek, Pavel; Hanč, Petr; Lebeda, Ondřej; Panek, T.; Vognar, M.

    2003-01-01

    Roč. 53, č. 2 (2003), s. A737-A743 ISSN 0011-4626 R&D Projects: GA AV ČR KSK4055109 Keywords : cyclotron * radiopharmaceuticals Subject RIV: CH - Nuclear ; Quantum Chemistry Impact factor: 0.263, year: 2003

  19. Quality assurance of radiopharmaceuticals-specifications and test procedures

    International Nuclear Information System (INIS)

    Baldas, J.; Bonnyman, J.; Pojer, P.M.

    1981-08-01

    This report is a compilation of test methods used and specifications adopted for the Radiopharmaceutical Quality Assurance Test Programme conducted by the Australian Radiation Laboratory. In some cases test procedures described have been taken from various Pharmacopoeias or methods published in the literature. In other cases test methods have been developed at the ARL

  20. Radioisotope requirements and usage in the radiopharmaceutical industry

    International Nuclear Information System (INIS)

    Langton, M.A.

    1995-01-01

    Radioisotopes are used extensively in many different productive and beneficial human endeavors. Amersham International, a U.K.-based company originating in the British Scientific Civil Service during World War II, has been actively involved in many of these activities for more than 50 yr. Today they are one of the world's largest suppliers of radioactive compounds and scaled radiation sources for use in industrial quality and safety assurance, life science research, and medicine. This paper outlines one of these applications: the use of radioisotopes as radiopharmaceuticals. Radiopharmaceuticals are radioactive nuclides and labeled compounds that have been developed for the diagnosis and treatment of (human) disease. They are manufactured via highly controlled processes and have gone through regulatory scrutiny and approval far in excess of other radioisotopes used in other applications. Radiopharmaceuticals can be conveniently split into two categories. One type is simply an active analog that mimics the physiological behavior of its inactive counterpart in the body. The other involves an actual pharmacological compound that exhibits the desired physiological behavior, which is then labeled with a radionuclide suitable for either imaging or the delivery of a therapeutic radiation dose as appropriate but which plays no part in the mechanism of action of the drug. The latter type, which is the more common of the two, can be supplied either as an active compounded product or as a open-quotes cold kit,close quotes which is then labeled with the appropriate radiopharmaceutical-grade radionuclide to yield the final product

  1. Routine clinical use of radiopharmaceuticals in Latin American developing countries

    International Nuclear Information System (INIS)

    Mitta, A.E.

    1985-01-01

    The paper describes the routine clinical use of radiopharmaceuticals in the developing countries of Latin America made possible by: (1) the International Atomic Energy Agency (IAEA), which sent experts and equipment to many countries and made a substantial bibliographic contribution on the subject; (2) the Latin American Association of Societies of Nuclear Biology and Medicine (ALASBIMN), which fostered the exchange of data on techniques of radiopharmaceutical preparation and quality control by providing materials for tests, etc., and by publishing quality control manuals in some countries, finally in 1982 producing the Manual of Radiopharmaceutical Quality Control, in collaboration with the Inter-American Nuclear Energy Commission (CIEN) and published by the Organization of American States (OAS); (3) the countries themselves under agreements between their atomic energy commissions; (4) radiopharmacy courses organized by universities, either alone or in collaboration with the IAEA, WHO, etc.; (5) professional workers who established radiopharmaceutical services at private centres. Finally, the societies of nuclear medicine and biology in each country, the World Federation of Nuclear Medicine and Biology, the ALASBIMN, the IAEA, etc. organized symposia and meetings which afforded opportunities to professionals of these countries to receive and exchange information, since in Latin America, given its language and human characteristics, the problems are similar. The countries referred to are Argentina, Brazil, Mexico, Uruguay, Bolivia, Paraguay, Chile, Peru, Ecuador, Colombia, Venezuela, Costa Rica, Guatemala, Puerto Rico, El Salvador and Panama; little is known about Honduras, Nicaragua, the Dominican Republic and Cuba. (author)

  2. Towards a harmonized radiopharmaceutical regulatory framework in Europe

    International Nuclear Information System (INIS)

    Decristoforo, A.; Penuelas, I.

    2009-01-01

    Despite European unification regarding a common legal framework for many aspects of pharmaceutical production including industrial manufacture of pharmaceuticals, the practice of pharmacy in general, and of radiopharmacy in particular, differs substantially and are mainly regulated at the national level. Herein the authors discuss major European documents relevant for radiopharmacy practice in Europe and recent developments on the national level especially regarding the small-scale preparation of radiopharmaceuticals (R P). Issues related to marketing authorization (and exemptions from it), standards of preparation, quality requirements, regulations of clinical trials and education will be outlined. Standards for the industrial preparation of pharmaceuticals are defined in Good Manufacturing Practice (GMP), not taking into account specific requirements for the small scale, extemporaneous preparation of R P. The European Association of Nuclear Medicine EANM has published several documents based on GMP and called Good Radiopharmaceutical Practice (cGRPP) to specifically address this in an attempt to harmonize R P preparation across Europe. Clinical trials have been hampered by the introduction of directive 2001/20/E C again aimed at the marketing track of industrial production and currently a number of activities are ongoing to counterbalance this problem in radiopharmaceutical research. Additionally, the role of the European Pharmacopoeia in regulating quality requirements and the need for specific education and training in the small scale radiopharmaceutical preparation are also discussed.

  3. Sixth international symposium on radiopharmaceutical chemistry: Abstracts: Final report

    International Nuclear Information System (INIS)

    1986-01-01

    The 113 abstracts are arranged under the following section headings: alkyl spiperone derivatives labeled with fluorine, synthesis of compounds labeled with positron emitters, technetium compounds, positron emitters (target design and synthesis), indium and gallium, halogens, labeled proteins and antibodies, radiopharmaceuticals for brain and SPECT, general, and receptor radioligands

  4. Dispersion for the preparation of an injectable radiopharmaceutical scanning agent

    International Nuclear Information System (INIS)

    Wolfangel, R.G.

    1976-01-01

    The invention deals with the preparation of a dispersion of a tin (II) sulphur colloid in an aqueous solution with additions of a stabilizing agent. Labelled with sup(99m)Tc, the dispersion can be used as an injectable radiopharmaceutical scanning agent. (VJ) [de

  5. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 1992

    International Nuclear Information System (INIS)

    Johannsen, B.

    1993-04-01

    The Institute of Bioinorganic and Radiopharmaceutical Chemistry of the Rossendorf Research Center (FZR) presents its 1992 anual report in order to in form on research activities in the first year of its existence. This volume contains 27 individual reports devoted to various aspects of radiotracers for nuclear medicine. (BBR)

  6. Positron emitting nuclides and their synthetic incorporation in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Fowler, J.S.

    1976-01-01

    11 C, 13 N, and 15 O has potential applicability to the study of metabolism in humans. Problems in the synthesis of radiopharmaceuticals labeled with 11 C, 13 N, and 18 F are described: quality control, radiation exposure, carboxylic acids, glucose, amines, amino acids, nitrosources, fluoroethanol. 54 references

  7. Radiopharmaceutical therapy in Dominican Republic. Present and future

    International Nuclear Information System (INIS)

    Johny Osvaldo de los Santos

    2005-01-01

    Full text: In this paper we present experience in Dominican Republic on Radiopharmaceutical Therapy. In our country, there are 8 Center with Nuclear Medicine Department. Only, 7 centers are working with Radiopharmaceutical Therapy. Radioiodine treatment with I-131 in Thyroid diseases(Thyroid Cancer and Hyperthyroidism). This is only Nuclear Medicine therapy available in Dominican Republic. The objectives of this paper are to analyze and assess the difficulties and facilities for the development of Radiopharmaceutical Therapy in Dominican Republic. We made surveys with the help of Nuclear Medicine Physicians of different Nuclear Medicine departments. 8 Nuclear Physicians accepted the interview. Two of these Nuclear Medicine Centers are Department of a Cancer Center and they have many patients for therapies. In the majority opinion of Physicians, Cost of Radiopharmaceuticals is principal problem to use Therapy in Dominican Republic. In addition the following problems were identified: Lack of awareness about new therapy in Nuclear Medicine among Physicians of other specialties, lack of adequate training in the current trends of radionuclide therapy and finally lack of basic infrastructure, equipment and finances to buy radiopharmaceuticals and introduce radionuclide therapy. For this reason, Nuclear Medicine Centers prefer to work with only I-131 Therapy and they do not have new programs to start other therapies. In the near future, our department of Nuclear Medicine will work with I-131, pain palliation, treatment of metastatic disease and Treatment of benign diseases. We have interest in offering other therapies in the department and we hope that other departments with more resources, have the same interest, to enhance practice of radionuclide therapy in our country. (author)

  8. Radiopharmacy and radiopharmaceuticals in Brazil: sanitarians aspects related to a project of an industry of PET radiopharmaceuticals

    International Nuclear Information System (INIS)

    Santos-Oliveira, Ralph; Benevides, Clayton Augusto; Hwang, Suy Ferreira; Salvi, Roberto Paulo Camara; Freitas, Ione Maria Acioly Teixeira Ricarte de

    2008-01-01

    The increasing use of radiopharmaceuticals for PET (Positron Emission Tomography) has come to the attention of nuclear medicine staff and regulatory bodies. The aim of this study is to provide a national reference in radiopharmacy that could help all nuclear medicine staff and specially the Brazilian's regulatory bodies focused on the industrial project. (author)

  9. New technologies for production of radiopharmaceuticals and other medical preparations

    International Nuclear Information System (INIS)

    Bazaniak, Z.; Iller, E.; Mikolajczak, R.

    2004-01-01

    The Radioisotope Centre POLATOM belongs to the group of R and D institutions whose profile of activities comprises, besides applied research work, also manufacturing of a range of products based on implementation of the Centre's own developments. The Centre possesses considerable experience in its area of expertise: forty-six years of manufacturing of various radiation sources and radiopharmaceuticals, performing metrology and analysis of radioactive materials, which makes OBRI a unique R and D unit. The Centre is a chief manufacturer supplier of radiopharmaceuticals for nuclear medicine in Poland, and also an active exporter with a market of several tens countries. The current trends in the Centre activity assume combination of R and D work with practical application of its results for production purposes. The undertaken research topics are studied in co-operation with domestic and foreign scientific institutions. (author)

  10. Impact of risk considerations on dosimetry of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Eckerman, K.F.

    1981-01-01

    Estimates of the absorbed dose from clinical procedures involving the administration of radiopharmaceuticals are used primarily to determine the presumed risk of various procedures so that, in-so-far as possible, the selection of a given procedure can be based on a comparison of risk. Although this has been the basic objective, risk evaluation has generally been separated from the dosimetry considerations. In the recent revision of its radiation protection guidance, the International Commission on Radiological Protection (ICRP) has embodied risk considerations in its recommendations and risk concepts have become an integral part of the dosimetric framework. The impact of these considerations on the dosimetric assessments of radiopharmaceuticals and the resulting need for additional information is discussed

  11. Developments in radioisotope production and labelling of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Lambrecht, R.M.

    1998-01-01

    Recent developments in both reactor and accelerator production of radioisotopes finding applications in nuclear medicine and in biomedical research are summarised. The priorities for the production of 48 different cyclotron radioisotopes; and for 42 reactor produced radioisotopes finding biomedical applications are identified. Each includes 5 generator systems. The rapid expansion of cyclotron based radioisotope production and automated synthesis of short-lived radiopharmaceuticals with the position-emitting radionuclides continues to gain momentum. Recent feasibility studies of the cyclotron production of 186 Re, 99m Tc and of 99 Mo are cited as examples of motivation to develop accelerator alternatives to use of nuclear reactors for medical radioisotope production. Examples of SPET and PET radiopharmaceuticals labelled with 131 I, 123 I, 124 I, 18 F, and with therapeutic radionuclides are highlighted. (author)

  12. Procedures of quality control of radiopharmaceutical activity counters

    International Nuclear Information System (INIS)

    Oliveira, A.E. de; Iwahara, A.; Gaast, H.A. van der; Buckman, S.M.

    1999-01-01

    The Radionuclides Metrology Supervision-Ionizing Radiation Metrology National Laboratory maintain and distributes the brazilian standards for radioactivity measurements. The Brazilian Institute for Metrology, Regulation and Industrial Quality (INMETRO), which is the brazilian authority for standards verification, is coordinating the enhancement of the standards distribution. Concerning to the nuclear medicine related radioisotopes, this network will provide for calibration of brazilian hospitals and clinics instruments, assuring great accuracy of the radiopharmaceuticals activities. This work gives details of the calibration quality control procedures recommended by the Radionuclides Metrology Supervisory (Brazilian National Nuclear Energy Commission) and the Radioactive Standards Division of the Australian Nuclear Technology and Science Organization (ANSTO). This information can be used as a guide for the brazilian nuclear medicine services guaranty on the accuracy and precision of the radiopharmaceuticals activity measurements measurements

  13. Influence of radioactive contaminants on absorbed dose estimates for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Watson, E.E.; Stabin, M.G.

    1986-01-01

    Several popular radiopharmaceutical products contain low levels of radioactive contaminants. These contaminants increase the radiation absorbed dose to the patient without any increased benefit and, in some cases, with a decrease in image quality. The importance of a contaminant to the radiation dosimetry picture is a function of 1) the contaminant level, 2) the physical half-life of the contaminant, 3) the organ uptake and the biological half-time of the contaminant in the various body systems, and 4) the decay mode, energy, etc. of the contaminant. The general influence of these parameters is discussed in this paper; families of curves are included that reflect the changing importance of contaminant dosimetry with respect to the primary radionuclide as a function of these variables. Several specific examples are also given of currently used radiopharmaceutical products which can contain radioactive contaminants (I-123, In-111, Tl-201, Ir-191m, Rb-82, Au-195m). 7 references, 8 figures, 4 tables

  14. Cerenkov Luminescence Tomography for In Vivo Radiopharmaceutical Imaging

    Directory of Open Access Journals (Sweden)

    Jianghong Zhong

    2011-01-01

    Full Text Available Cerenkov luminescence imaging (CLI is a cost-effective molecular imaging tool for biomedical applications of radiotracers. The introduction of Cerenkov luminescence tomography (CLT relative to planar CLI can be compared to the development of X-ray CT based on radiography. With CLT, quantitative and localized analysis of a radiopharmaceutical distribution becomes feasible. In this contribution, a feasibility study of in vivo radiopharmaceutical imaging in heterogeneous medium is presented. Coupled with a multimodal in vivo imaging system, this CLT reconstruction method allows precise anatomical registration of the positron probe in heterogeneous tissues and facilitates the more widespread application of radiotracers. Source distribution inside the small animal is obtained from CLT reconstruction. The experimental results demonstrated that CLT can be employed as an available in vivo tomographic imaging of charged particle emitters in a heterogeneous medium.

  15. Abbreviated New Drug Applications (ANDAS): Future trend in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kishore, R.

    1990-01-01

    The Drug Price Competition and Patent Term Restoration Act (commonly called Waxman Hatch Amendment) of 1984, to the Federal Food, Drug, and Cosmetic Act provided for abbreviated new drug applications (ANDAs) if the conditions specified in the Code of Federal Regulations (CFR) Title 21, subsection 312.55 are met. Under this subsection, reports of nonclinical laboratory studies and clinical investigations can be omitted. New drugs approved under these regulations are so called generic drugs as opposed to listed or pioneer (innovator) drugs. As the patents on more and more radiopharmaceuticals reach their expiration, the radiopharmaceutical industry is likely to produce more of these generic versions of innovator drugs. The ANDAs are required to contain information specified under subsections 314.50(a), (b), (d)(1) and (3), (e), and (g)

  16. Infection imaging with radiopharmaceuticals in the 21st century

    Energy Technology Data Exchange (ETDEWEB)

    Das, Satya S.; Wareham, David W. [St. Bartholomew' s Hospital, London (United Kingdom). Dept. of Medical Microbiology; Britton, Keith E. [St. Bartholomew' s Hospital, London (United Kingdom). Dept. of Nuclear Medicine; Hall, Anne V. [Harefield Hospital, Middlesex (United Kingdom). Microbiology Dept.

    2002-09-01

    Infection continues to be a major cause of morbidity and mortality worldwide. Nuclear medicine has an important role in aiding the diagnosis of particularly deep-seated infections such as abscesses, osteomyelitis, septic arthritis, endocarditis, and infections of prosthetic devices. Established techniques such as radiolabelled leucocytes are sensitive and specific for inflammation but do not distinguish between infective and non-infective inflammation. The challenge for Nuclear Medicine in infection imaging in the 21st century is to build on the recent trend towards the development of more infection specific radiopharmaceuticals, such as radiolabelled anti-infectives (e.g. 99 m Tc ciprofloxacin). In addition to aiding early diagnosis of infection, through serial imaging these agents might prove very useful in monitoring the response to and determining the optimum duration of anti-infective therapy. This article reviews the current approach to infection imaging with radiopharmaceuticals nd the future direction it might take. (author)

  17. Infection imaging with radiopharmaceuticals in the 21st century

    International Nuclear Information System (INIS)

    Das, Satya S.; Wareham, David W.; Britton, Keith E.; Hall, Anne V.

    2002-01-01

    Infection continues to be a major cause of morbidity and mortality worldwide. Nuclear medicine has an important role in aiding the diagnosis of particularly deep-seated infections such as abscesses, osteomyelitis, septic arthritis, endocarditis, and infections of prosthetic devices. Established techniques such as radiolabelled leucocytes are sensitive and specific for inflammation but do not distinguish between infective and non-infective inflammation. The challenge for Nuclear Medicine in infection imaging in the 21st century is to build on the recent trend towards the development of more infection specific radiopharmaceuticals, such as radiolabelled anti-infectives (e.g. 99 m Tc ciprofloxacin). In addition to aiding early diagnosis of infection, through serial imaging these agents might prove very useful in monitoring the response to and determining the optimum duration of anti-infective therapy. This article reviews the current approach to infection imaging with radiopharmaceuticals nd the future direction it might take. (author)

  18. Radiopharmaceuticals using radioactive compounds in pharmaceutics and medicine

    International Nuclear Information System (INIS)

    Theobald, A.

    1989-01-01

    This review of the latest techniques and developments indicates the importance of radiopharmaceutical techniques in the development of drug compounds. It presents practical demonstrations, offers practical exercises, as well as the underlying theoretical considerations: it will supplement existing (mostly American) texts in this subject, since most industrial pharmaceutical companies have a keen interest in the area and most pharmaceutical courses include the subject at degree level. The authors emphasize the pharmaceutical applications throughout. They review targeting aspects, including cell and protein labelling: and discuss radiotracers in testing dosage forms and formulation studies. Safety and legislation are considered, with reviews of the handling techniques, radiation monitoring, radiochromatography and the use of computer techniques. The latter part of the work discusses standards for radiopharmaceuticals, sterility and pyrogen testing, as well as both radiochromatographic and electrophoretic methods and their importance to quality control. (author)

  19. Airtight miniaturized chromatography: a safer method for radiopharmaceutical quality control

    International Nuclear Information System (INIS)

    Coupal, J.J.; Shih, W.J.; Ryo, U.Y.

    1988-01-01

    Miniaturized chromatography is widely used for quality control of radiopharmaceuticals. Recently, published chromatography procedures have illustrated or described chromatography chambers open to the air in use, suggesting that volatile toxic mobile phases are harmless to people in the vicinity. The authors describe the results of their search for an inexpensive closed chromatography chamber that can be used to derive safely the benefits from conventional miniaturized chromatography

  20. Adherence of radiopharmaceuticals and labeled cells to intravenous tubing

    International Nuclear Information System (INIS)

    Segall, G.M.; Gurevich, N.; McDougall, I.R.

    1986-01-01

    A survey of 67 nuclear medicine departments revealed no agreement on which radiolabeled agents could be injected through intravenous lines (IVs) and which required direct venipuncture. Labeled cells and several common radiopharmaceuticals were tested for adherence to intravenous tubing. Residual activity remaining in the tubing after an adequate flush was less than 1% of the injected dose in each case. Administration of radiolabeled agents through existing IVs is an acceptable alternative to direct venipuncture in many cases

  1. Institute of Bioinorganic and Radiopharmaceutical Chemistry. Annual report 2001

    International Nuclear Information System (INIS)

    Johannsen, B.; Seifert, S.

    2002-01-01

    In 2001 the Forschungszentrum Rossendorf e.V. continued and further developed its basic and application-oriented research. Research at the Institute of Bioinorganic and Radiopharmaceutical Chemistry, one of five institutes in the Research Centre, was focused on radiotracers as molecular probes to make the human body biochemically transparent with regard to individual molecular reactions. As illustrated by the large number of contributions in this report, the Institute is predominantly engaged in the coordination chemistry and radiopharmacology of technetium and rhenium. (orig.)

  2. To the radiotoxicity of {sup 99m}Tc radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Ftacnikova, S [Inst. of Preventive and Clinical Medicine, 83301 Bratislava (Slovakia)

    1996-12-31

    In this paper the radiotoxicity and RBE values of Auger electrons for {sup 99m}Tc radiopharmaceuticals were discussed. Expression for the expected RBE for {sup 99m}Tc compounds is given. For the Auger electrons emitted in the decay of {sup 99m}Tc the RBE(Auger) = 10 and a value of 20 for the radiation weighing factor were recommended. (J.K.) 4 refs.

  3. Molecular Engineering of Technetium and Rhenium Based Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Zubieta, J.

    2003-01-01

    The research was based on the observation that despite the extraordinarily rich coordination chemistry of technetium and rhenium and several notable successes in reagent design, the extensive investigations by numerous research groups on a variety of N 2 S 2 and N 3 S donor type ligands and on HYNIC have revealed that the chemistries of these ligands with Tc and Re are rather complex, giving rise to considerable difficulties in the development of reliable procedures for the development of radiopharmaceutical reagents

  4. Radiopharmaceuticals and other compounds labelled with short-lived radionuclides

    CERN Document Server

    Welch, Michael J

    2013-01-01

    Radiopharmaceuticals and Other Compounds Labelled with Short-Lived Radionuclides covers through both review and contributed articles the potential applications and developments in labeling with short-lived radionuclides whose use is restricted to institutions with accelerators. The book discusses the current and potential use of generator-produced radionuclides as well as other short-lived radionuclides, and the problems of quality control of such labeled compounds. The book is useful to nuclear medicine physicians.

  5. Improving radiopharmaceutical supply chain safety by implementing bar code technology.

    Science.gov (United States)

    Matanza, David; Hallouard, François; Rioufol, Catherine; Fessi, Hatem; Fraysse, Marc

    2014-11-01

    The aim of this study was to describe and evaluate an approach for improving radiopharmaceutical supply chain safety by implementing bar code technology. We first evaluated the current situation of our radiopharmaceutical supply chain and, by means of the ALARM protocol, analysed two dispensing errors that occurred in our department. Thereafter, we implemented a bar code system to secure selected key stages of the radiopharmaceutical supply chain. Finally, we evaluated the cost of this implementation, from overtime, to overheads, to additional radiation exposure to workers. An analysis of the events that occurred revealed a lack of identification of prepared or dispensed drugs. Moreover, the evaluation of the current radiopharmaceutical supply chain showed that the dispensation and injection steps needed to be further secured. The bar code system was used to reinforce product identification at three selected key stages: at usable stock entry; at preparation-dispensation; and during administration, allowing to check conformity between the labelling of the delivered product (identity and activity) and the prescription. The extra time needed for all these steps had no impact on the number and successful conduct of examinations. The investment cost was reduced (2600 euros for new material and 30 euros a year for additional supplies) because of pre-existing computing equipment. With regard to the radiation exposure to workers there was an insignificant overexposure for hands with this new organization because of the labelling and scanning processes of radiolabelled preparation vials. Implementation of bar code technology is now an essential part of a global securing approach towards optimum patient management.

  6. Radiopharmaceuticals - pattern and development and utilisation in India

    International Nuclear Information System (INIS)

    Iya, V.K.; Mani, R.S.

    1990-01-01

    The availability of research reactors at an early stage of India's Atomic Energy Programme led to developemental efforts in the field of radiopharmaceuticals. The use of several 125 I-labelled compounds like Rose-Bengal, hippuran, etc. for imaging has been replaced over the years by 99m Tc compounds; the final formulations are prepared at the hospital using generators and cold kits supplied by the Board of Radioisotope Technology. Parallel with the development of short-lived generators in radiopharmaceuticals came advances in imaging and instrumentation techniques, the scanners being replaced by sophisticated gamma cameras, with capabilities for tomography and computerisation. About 40 centres in India have the modern instrumentation and equipment needed for carrying out nuclear medicine procedures. Further growth of nuclear medicine centres in the country has, however, been limited by the need to import such advanced high cost instumentation not currently available from indigeneous sources. Regarding in-vitro radiopharmaceuticals, some RIA and IRMA kits and procedures have been developed. These include assay of T 3 , T 4 and TSH in the thyroid group of hormones. There are over a hundred and fifty medical laboratories carrying out RIA procedures. (author)

  7. Recent radiopharmaceutical research at the AAEC Research Establishment

    International Nuclear Information System (INIS)

    Wilson, J.G.; Boyd, R.E.

    1985-12-01

    During the past few years a large part of the radiochemical research carried out at Lucas Heights has been devoted to the synthesis of ligands capable of forming chelate complexes with technetium-99m, as part of a search for tumour-localising radiopharmaceuticals. An account is given of the synthesis and biological evaluation of a range of these compounds and of the investigation of certain biochemical and biological properties affecting the clinical application of both ligands and radiopharmaceuticals. In addition to the search for novel Tc-99m radiopharmaceuticals, major research programs on the development of Tc-99m generating systems have been in progress at Lucas Heights for several years. Work on the AAEC's Mark III Tc-99m technetium generator has been brought to a successful conclusion. A new type of Tc-99m generator, which uses an insoluble zirconium molybdate gel and provides high yields of pertechnetate by a simple elution technique, has also been developed. Studies are in progress on the osmium-iridium generator

  8. Synthesis and formulation of 99m Tc-ECD radiopharmaceutical

    International Nuclear Information System (INIS)

    Ocampo G, B.E.

    1998-01-01

    Nuclear medicine is a medical specialty which uses radioactive compounds (radionuclides) for diagnostic and therapeutic purposes. 99m Tc is the more common radionuclide used in many studies in nuclear medicine because its advantages: it has a photopeak of 140 KeV and a half-life of 6 hours; it can be eluted from a Molybdenum 99 generator, so radiopharmaceuticals can be prepared on site. Ethyl cysteine dimer (ECD) labelled with reduced Technetium 99m has been purposed recently as a promising radiopharmaceutical for brain perfusion imaging 99m Tc-ECD is a lipophilic neutral complex which cross the brain blood barrier and show high brain uptake. The objective of this work was synthesize and to design a freeze dried formulation for the instant preparation of 99m Tc-ECD complex useful for brain perfusion imaging. We obtained a freeze dried stable formulation for the preparation of 99m Tc-ECD kit with a radiochemical purity higher than 90 %, which fulfills with the quality control of radiopharmaceuticals. Furthermore, we developed analytic techniques for the determination of the different chemical compounds into the lyophilized kit. (Author)

  9. Radionuclides, radiotracers and radiopharmaceuticals for in vivo diagnosis

    International Nuclear Information System (INIS)

    Wiebe, L.I.

    1984-01-01

    Radioactive tracers for in vivo clinical diagnosis fall within a narrow, strictly-defined set of specifications in respect of their physical properties, chemical and biochemical characteristics, and medical applications. The type of radioactive decay and physical half-life of the radionuclide are immutable properties which, along with the demands of production and supply, limit the choice of radionuclides used in medicine to only a small fraction of those known to exist. In use, the biochemical and physiological properties of a radiotracer are dictated by the chemical form of the radionuclide. This chemical form may range from elemental, molecular or ionic, to complex compounds formed by coordinate or covalent bonding of the radionuclide to either simple organic or inorganic molecules, or complex macromolecules. Few of the radiotracers which are tested in model systems ever become radiopharmaceuticals in the strictest sense. Radionuclides, radiotracers and radiopharmaceuticals in use are reviewed. Drug legislation and regulations concerning drug manufacture, as well as hospital ethical constraints and legislation concerning unsealed sources of radiation must all be satisfied in order to translate a radiopharmaceutical from the laboratory to clinical use. (author)

  10. Radionuclides, radiotracers and radiopharmaceuticals for in vivo diagnosis

    Science.gov (United States)

    Wiebe, Leonard I.

    Radioactive tracers for in vivo clinical diagnosis fall within a narrow, strictly-defined set of specifications in respect of their physical properties, chemical and biochemical characteristics, and (approved) medical applications. The type of radioactive decay and physical half-life of the radionuclide are immutable properties which, along with the demands of production and supply, limit the choice of radionuclides used in medicine to only a small fraction of those known to exist. In use, the biochemical and physiological properties of a radiotracer are dictated by the chemical form of the radionuclide. This chemical form may range from elemental, molecular or ionic, to complex compounds formed by coordinate or covalent bonding of the radionuclide to either simple organic or inorganic molecules, or complex macromolecules. Few of the radiotracers which are tested in model systems ever become radiopharmaceuticals in the strictest sense. Radionuclides, radiotracers and radiopharmaceuticals in use are reviewed. Drug legislation and regulations concerning drug manufacture, as well as hospital ethical constraints and legislation concerning unsealed sources of radiation must all be satisfied in order to translate a radiopharmaceutical from the laboratory to clinical use.

  11. Bone-seeking radiopharmaceuticals in skeletal malignancy: evolution, not revolution

    International Nuclear Information System (INIS)

    MacFarlane, D.

    2003-01-01

    Many advanced malignancies are complicated by skeletal metastases, with attendant pain and disability. External beam radiotherapy is still the most effective treatment for isolated lesions. Bone-seeking radiopharmaceuticals were perceived as a means of delivering radiation to multiple lesions simultaneously. A wide variety of radioisotopes have been used in this endeavor, with myelosuppression being the most significant potential adverse effect. Benefits of treatment are modest, including a transient improvement in pain control and perhaps prolongation of the treatment-free period. This is best demonstrated in prostate cancer with lower responses by skeletal metastases from breast and lung cancers. However, the treatment is yet to produce any improvement in patient survival. Experimental approaches to improve treatment efficacy include combination with cytotoxic therapy, and administration earlier in the course of the disease. Bone seeking radiopharmaceuticals have been used in treatment of advanced osteosarcoma in humans and canines and achieved effective palliation. The myelosuppressive effects of these agents have been exploited in patients with multiple myeloma to assist in attaining myeloablation prior to stem cell transplantation. Development of more potent non-radiolabelled bisphosphonates and recognition of their antitumour effect against several tumours has sparked a recrudescence of interest in their use for bone metastases. Set against these developments, the role of bone-seeking radiopharmaceuticals in skeletal metastases may need to be redefined

  12. Export of radiopharmaceuticals and establishment of export base of cyclotron

    International Nuclear Information System (INIS)

    Jung, Kyungil; Kim, Youngsik

    2006-01-01

    Sam young Unit ech has seized an opportunity to advance into the radiopharmaceuticals market through successful transfer of radiopharmaceuticals manufacturing technology and medical cyclotron, an original technology in nuclear medicine that is the core of less developed areas in nuclear-related fields. The company has continued to push for research development and establishment of market base through industry-academia-research center cooperation with an aim to complement relatively less developed domestic technology and market than in advanced countries, and is making efforts to establish export base in the overseas market based on stabilized supply in the domestic market. As for radiopharmaceuticals, the company is exporting Tc-99m generator to Vietnam, Thailand and the Philippines and preparing itself to export manufacture facilities for Tc-99m generator to Syria and Kazakhstan. In addition, it plans to export 13Mev Cyclotron that has been commercialized after being developed in the domestic market to the U. S. The company plans to grow up to play a pivotal role in the domestic RT area by conducting proactive business activities with an aim to revitalize the domestic market and further domestic original technologies and products in the global market

  13. Short-lived radiopharmaceutical development at E.R. Squibb and Sons, Inc

    International Nuclear Information System (INIS)

    Loberg, M.D.

    1985-01-01

    This paper describes the present status and future plans of E.R. Squibb and Sons, Inc. as they relate to the development of short-lived radiopharmaceuticals. The advantages of short-lived radiopharmaceuticals are summarized as are the problems inherent in their manufacture, quality control, and distribution. The nuclear generator is advocated as the best means of distributing short-lived radiopharmaceuticals. The E.R. Squibb and Sons work with the 82 Sr → 82 Rb generator is summarized

  14. Legislative situation of EEC member states and european provisions concerning preparation and use of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Lalanne, P.

    1977-01-01

    Radiopharmaceuticals are excluded from the directives on pharmaceutical products and considerable gaps exist in the legislation of many countries. The pharmacopoeia provides standards and methods for the quality control of the final product. According to the same principles, it is proposed that special provisions, taking into consideration the very special nature of radiopharmaceuticals, might be introduced in the european economic community legislation, to secure that all radiopharmaceuticals used are safe and of an uniform quality

  15. Detection of endotoxins in radiopharmaceutical preparations. III. Limulus test assessment using radiopharmaceutical preparations; correlation with the rabbit pyrogen test

    Energy Technology Data Exchange (ETDEWEB)

    Cohen, Y; Bahri, F; Bruneau, J; Dubuis, M; Dubuis, N; Merlin, L; Michaud, T; Peysson, S

    1986-01-01

    Experiments using 17 radiopharmaceuticals containing known amounts of added endotoxin show that none of them inhibits the pyrogenic reaction of the rabbit. Gelation of the Limulus amoebocyte lysate (LAL) is inhibited by 4 of them: colloidal erbium 169Er citrate, colloidal rhenium 186Re sulfide, colloidal technetium /sup 99m/Tc (Re) sulfide for liver scintigraphy and the colloidal technetium /sup 99m/Tc (Re) sulfide for lymphography. This inhibition is cancelled, either by dilution or after neutral pH adjustment. Both controls were performed on 313 batches of various radiopharmaceuticals, 95% of results were identical (93% negative, 2% positive). The remaining 5% correspond to positive LAL tests vs negative rabbit tests on the same batches. No negative LAL test vs positive rabbit test was observed.

  16. The role of high performance liquid chromatography in radiochemical/radiopharmaceutical synthesis and quality assurance

    International Nuclear Information System (INIS)

    Boothe, T.E.; Emran, A.M.

    1990-01-01

    The usefulness of HPLC in all areas of radiopharmaceutics has been demonstrated in numerous laboratories, particularly in the development of in-house radiopharmaceuticals for SPECT and PET. HPLC continues to be a powerful tool in preparation and quality assurance (QA) as illustrated in such areas as chemical and radiochemical identification; product separation and isolation; preparative scale purification; and specific activity determination. A review of established HPLC techniques in radiopharmaceutics will be presented. Examples from the literature as well as newer applications will be used in an attempt to assess and define the present-day role of HPLC in the preparation of radiochemicals and radiopharmaceuticals with emphasis on QA

  17. 99m Tc-labeled dendrimers as a potential radiopharmaceutical for tumor diagnosis process

    International Nuclear Information System (INIS)

    Tassano Hartwich, M.

    2008-01-01

    The present thesis to access the Bachelor of Biological Sciences studies the following: biology, molecular biology, pathology, radiotherapy, radiopharmaceuticals, research techniques and malignant neoplasms

  18. Preparation of sup(113m)In-labelled compounds of radiopharmaceutical interest. Part of a coordinated programme on radiopharmaceuticals

    International Nuclear Information System (INIS)

    Servian, J.; Robles, A.

    1975-06-01

    Techniques for the preparation and control of already known and new sup(113m)In-radiopharmaceuticals were investigated. New rapid procedures for the control and preparation of a number of radiopharmaceuticals were developed and standardized. After biological distribution studies and clinical tests, new techniques for the preparation of the following indium-113 radiopharmaceuticals were adopted: a) Indium - labelled colloids of: S, Al(OH) 3 , Fe(OH) 3 and AlPO 4 for liver and spleen scintigraphy. b) Indium labelled chelates using the ligands EDTA, DTPA, TTHA (Triethylene-tetramine-hexaacetic acid) and DHPTA (Diamino-hydroxy-propane-tetraacetic acid) for brain scintigraphy. c) Indium labelled Fe(OH) 3 macroaggregates and microspheres for lung scintigraphy. d) Several complexes of sup(113m)In with different ligands (fluoride, tartrate, pyrophosphate, tripolyphosphate, trimetaphosphate, EHDP (or ethane-1-hydroxy-1, 1-diphosphonate), ethylendiamine-pyrophosphate were synthesized and its potential use as bone-scanning agents were evaluated. It was found that the complexes with tartrate, tripolyphosphate and EHDP show appreciable skeletal uptake (bone/muscle ratio are 9.0, 5.5, and 4.7 respectively), although they are inferior to the sup(99m)Tc bone-scanning agents. e) A new simple technique is proposed for the preparation of highly concentrated sup(113m)In solutions. The technique is based on the precipitation of In(OH) 3 , millipore filtration and redissolution in a small volume of 0.05 N HCl

  19. Development of radiopharmaceutical for radiosinovectomy; Desenvolvimento de radiofarmaco para radiosinovectomia

    Energy Technology Data Exchange (ETDEWEB)

    Couto, Renata Martinussi

    2009-07-01

    Radiopharmaceuticals prepared with different radionuclides have been used in diagnostic and therapeutic procedures in Nuclear Medicine. The interest in radionuclidic therapy has been increased in last years, with the introduction of new radiopharmaceuticals applied in the destruction of specific cells or to prevent its undesired proliferation. Radiosinovectomy (RSV) is a therapeutic modality that uses radiopharmaceuticals administered in the intra-articular cavity and represents an alternative to the treatment of different arthropaties and, in particular, the arthropaties derived from rheumatoid arthritis and haemophilic. The objective of the present work was to study the labeling of compounds with {sup 90}Y and {sup 177}Lu in order to improve the production conditions and quality control procedures, study the stability of the labeled compounds and preliminary biodistribution studies of the radiopharmaceuticals with potential for RSV applications. The study of the production of {sup 90}Y citrate colloid ({sup 90}Y-Cit) was based in a labeling procedure using {sup 90}Y Cl{sub 3} solution (37 - 54 MBq) that was previously dried, followed by the addition of yttrium nitrate and sodium citrate in p H 7 at 37 deg C for 30 minutes. The production of hydroxyapatite (HA) labeled with {sup 90}Y was based in a labeling procedure using mono hydrated citric acid, yttrium nitrate and {sup 90}Y Cl{sub 3} solution (37 - 370 MBq). The reaction mixture was incubated for 30 minutes at room temperature and the HA was introduced in aqueous medium and the reaction proceed for 30 minutes under strong stirring. {sup 177}Lu-HA was produced using {sup 177}Lu Cl{sub 3} solution (296 MBq), in presence of lutetium oxide in NaCl medium, p H 7, under continuous stirring for 30 minutes at room temperature. Several reaction parameters were studied for the three radiopharmaceuticals. Labeling yield was determined after particles were centrifuged and washed with NaCl 0,9%. Radiochemical purity was

  20. Radiopharmaceutical management in Brazil: the case of fluorodeoxyglucose production; Gestao de radiofarmacos no Brasil: o caso da producao de fluordesoxiglicose

    Energy Technology Data Exchange (ETDEWEB)

    Pereira, Vitor da Silva

    2016-07-01

    Nowadays, the combination of fluorodeoxyglucose tracer (FDG) and PET/CT equipment is the best technological condition for medical diagnosis, allowing the generation of images that associate anatomy and metabolic functions of tissues or organs. Constitutional Amendment (CA) No 49 of 2006, relaxed the state monopoly on the production of radioactive substances, allowing private investment in radioisotope area with half-life of less than or equal to two hours, as a way to increase the supply of these materials to national health sector. In order to reflect on the Brazilian production of radiopharmaceuticals, especially FDG was performed a theoretical study with a qualitative approach, substantiated by documentary research and data collection through a questionnaire sent to the producing private companies of this radiopharmaceutical. Initially, it sought to identify in the federal level the legal and regulatory parameters for the activity; then the existing competitive environment was observed, and, finally, were prospected the business perspectives on the behavior of domestic demand of this product. The results showed the growth of production and its largest geographical distribution in the country, beyond what would be possible only considering public investment; but short of expectations surrounding the enactment of Constitutional Amendment. Private entrepreneurs believe in market growth; since, most of the population has no access to the benefits that the medical imaging diagnostic with the use of FDG may allow. It was also noted that there is a need to improve the regulatory framework in relation to licensing procedures; as well as implementation of common marketing parameters. (author)

  1. Preparation of Radiopharmaceuticals Labeled with Metal Radionuclides. Final Report

    International Nuclear Information System (INIS)

    Welch, M.J.

    2012-01-01

    The overall goal of this project was to develop methods for the production of metal-based radionuclides, to develop metal-based radiopharmaceuticals and in a limited number of cases, to translate these agents to the clinical situation. Initial work concentrated on the application of the radionuclides of Cu, Cu-60, Cu-61 and Cu-64, as well as application of Ga-68 radiopharmaceuticals. Initially Cu-64 was produced at the Missouri University Research Reactor and experiments carried out at Washington University. A limited number of studies were carried out utilizing Cu-62, a generator produced radionuclide produced by Mallinckrodt Inc. (now Covidien). In these studies, copper-62-labeled pyruvaldehyde Bis(N 4 -methylthiosemicarbazonato)-copper(II) was studied as an agent for cerebral myocardial perfusion. A remote system for the production of this radiopharmaceutical was developed and a limited number of patient studies carried out with this agent. Various other copper radiopharmaceuticals were investigated, these included copper labeled blood imaging agents as well as Cu-64 labeled antibodies. Cu-64 labeled antibodies targeting colon cancer were translated to the human situation. Cu-64 was also used to label peptides (Cu-64 octriatide) and this is one of the first applications of a peptide radiolabeled with a positron emitting metal radionuclide. Investigations were then pursued on the preparation of the copper radionuclides on a small biomedical cyclotron. A system for the production of high specific activity Cu-64 was developed and initially the Cu-64 was utilized to study the hypoxic imaging agent Cu-64 ATSM. Utilizing the same target system, other positron emitting metal radionuclides were produced, these were Y-86 and Ga-66. Radiopharmaceuticals were labeled utilizing both of these radionuclides. Many studies were carried out in animal models on the uptake of Cu-ATSM in hypoxic tissue. The hypothesis is that Cu-ATSM retention in vivo is dependent upon the oxygen

  2. Analysis of residual solvents in PET radiopharmaceuticals by GC

    International Nuclear Information System (INIS)

    Li Yungang; Zhang Xiaojun; Liu Jian; Tian Jiahe; Zhang Jinming

    2013-01-01

    The residual solvents in PET radiopharmaceuticals were analyzed by GC, which were acetonitrile, ethanol, N, N-dimethylethanolamine (DMEA), dimethylsulfoxide (DMSO). The standard curves were established with the AT-624 capillary column at GC, and the sensitivity of acetonitrile and ethanol were 0.004-0.320 g/L and 0.010-0.120 g/L respectively. The residual solvents of acetonitrile, ethanol, DMEA and DMSO in PET radio- pharmaceuticals were analyzed by GC. The linearity were 0.9994, 0.9999, 0.9997, 0.999 6 respectively. The residual of acetonitrile were (0.0313±0.0433), (0.0829±0.0668), (0.0156±0.0059), (0.0254±0.0266) g/L in 18 F-FDG, 18 F-FLT, 11 C-CFT, 11 C-PIB respectively. The residual of ethanol was (0.0505±0.00528) g/L in 18 F-FDG. The residual of DMSO were (0.0331±0.0180) g/L, (0.0238±0.0100) g/L in 18 F-W372 and 11 C-DTBZ respectively. The residual of DMEA was (0.0348±0.0022) g/L in 11 C-Choline. The survived of organic solvent in PET radiopharmaceuticals can be analyzed with GC directly. The results showed that the QC should be done in PET radiopharmaceuticals purity with semi-HPLC to avoid the high residual. (authors)

  3. Profile of MIBI liquid phase radiopharmaceutical for myocardial imaging

    International Nuclear Information System (INIS)

    I Daruwati; ME Sriyani; NK Oekar; N Zainuddin; KA Hanafiah

    2016-01-01

    The 99m Tc-MIBI radiopharmaceutical has been used in nuclear medicine in Indonesia for myocardial imaging. BATAN researchers have mastered the technology to manufacture MIBI as a lyophilized kit. A reformulation of MIBI radiopharmaceutical has been conducted to improve the stability of the kit especially in the liquid-phase kit. Basically, radiopharmaceuticals in liquid form are not different from the dry kit. However in the manufacturing of liquid-phase kit, lyophilization process was not done. To improve the stability of liquid kit, a reformulation of the components was conducted by using two separate vials (Formulation 2) and the characteristics were compared with the one-vial formulation (Formulation 1). The MIBI Formulation 2 consists of two vials, vial A containing 0.06 mg of SnCl 2 2H 2 O and 2.6 mg Sodium Citrate 2H 2 O and vial B containing 0.5 mg of [Cu(MIBI) 4 ]BF 4 , 1 mg of cysteine hydrochloride, and 20 mg of mannitol. The purposes of this study were to determine the stability of two different formulations of MIBI as a liquid-phase kit, to compare their stability in different storage condition such as in refrigerator and freezer, and to compare the ratio of activities attained between target and nontarget organs after injection to animal model. As a diagnostic agent, MIBI was reconstituted with Technetium-99m as radionuclide tracer to 99m Tc-MIBI labeled compound. The radiochemical purity of 99m Tc-MIBI was determined by chromatography method using alumina thin-layer chromatography paper as the stationary phase and ethanol 95% as the mobile phase. The results showed MIBI Formulation 2 has a higher stability than Formulation 1. Formulation 2 also maintained a 96.68% radiochemical purity under 52-day storage and attained a target-to-nontarget activity ratio of 8.22. (author)

  4. Recent Progress toward Microfluidic Quality Control Testing of Radiopharmaceuticals

    Directory of Open Access Journals (Sweden)

    Noel S. Ha

    2017-11-01

    Full Text Available Radiopharmaceuticals labeled with short-lived positron-emitting or gamma-emitting isotopes are injected into patients just prior to performing positron emission tomography (PET or single photon emission tomography (SPECT scans, respectively. These imaging modalities are widely used in clinical care, as well as in the development and evaluation of new therapies in clinical research. Prior to injection, these radiopharmaceuticals (tracers must undergo quality control (QC testing to ensure product purity, identity, and safety for human use. Quality tests can be broadly categorized as (i pharmaceutical tests, needed to ensure molecular identity, physiological compatibility and that no microbiological, pyrogenic, chemical, or particulate contamination is present in the final preparation; and (ii radioactive tests, needed to ensure proper dosing and that there are no radiochemical and radionuclidic impurities that could interfere with the biodistribution or imaging. Performing the required QC tests is cumbersome and time-consuming, and requires an array of expensive analytical chemistry equipment and significant dedicated lab space. Calibrations, day of use tests, and documentation create an additional burden. Furthermore, in contrast to ordinary pharmaceuticals, each batch of short-lived radiopharmaceuticals must be manufactured and tested within a short period of time to avoid significant losses due to radioactive decay. To meet these challenges, several efforts are underway to develop integrated QC testing instruments that automatically perform and document all of the required tests. More recently, microfluidic quality control systems have been gaining increasing attention due to vastly reduced sample and reagent consumption, shorter analysis times, higher detection sensitivity, increased multiplexing, and reduced instrumentation size. In this review, we describe each of the required QC tests and conventional testing methods, followed by a

  5. The liability of the radiopharmacist and the nuclear physician in the use of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Coustou, F.

    1986-01-01

    A brief article examines the traditional aspects of the physician's and pharmacist's liability in general followed by a discussion on the liability of the nuclear physician and the radiopharmacist in the use of radiopharmaceuticals. It is concluded that the liabilities involved in the use of radiopharmaceuticals go well beyond the scope of traditional medicine and pharmacy. (UK)

  6. Survey of radiopharmaceuticals used for in vivo studies in medical practice in New Zealand

    International Nuclear Information System (INIS)

    McEwan, A.C.; Smyth, V.G.

    1984-01-01

    To obtain up-to-date information on numbers and types of radiopharmaceutical procedures, a survey was undertaken in the last quarter of 1983. In conjunction with this survey dosimetry data for the range of radiopharmaceutical procedures has been reviewed and extended where necessary so that effective dose equivalents could be estimated and mean genetically significant and malignancy significant doses for the population derived

  7. Radiopharmaceuticals and hospital radiopharmacy practices: course manual for accreditation/certification of hospital radiopharmacists

    International Nuclear Information System (INIS)

    Ramamoorthy, N.; Shivarudrappa, V.; Bhelose, Amita A.

    2000-02-01

    This manual on hospital radiopharmaceuticals and hospital radiopharmacy practices contains information and recommendations that could be of use to hospital radiopharmacists while the main focus of the book is to impart adequate exposure to basics of radiopharmaceuticals and purity and safety aspects of formulations to be made in hospital radiopharmacy. Papers relevant to INIS are indexed separately

  8. Public exposure due to the transport of radiopharmaceuticals; Exposicao do publico devido ao transporte de radiofarmacos

    Energy Technology Data Exchange (ETDEWEB)

    Rodrigues, Demerval L.; Carneiro, Janete C.G.G.; Sanches, Matias P.; Sordi, Gian Maria A.A., E-mail: dlrodri@ipen.b, E-mail: janetegc@ipen.b, E-mail: msanches@ipen.b, E-mail: gsordi@ipen.b [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2011-10-26

    This paper estimate the radiological impact resulting from radiopharmaceuticals transport from the IPEN to some destinations defined a priori. So, doses were estimated in the public individuals, which are in the streets and vehicles that transit near the public transport, alongside the itinerary went through by packages, during the realization of radiopharmaceuticals transport

  9. Advances in nuclear medicine and in radiopharmaceuticals, International meeting in Cabo Frio. Program and abstracts

    International Nuclear Information System (INIS)

    2002-01-01

    The meeting of Advances in Nuclear Medicine and in Radiopharmaceuticals, held in Cabo Frio, Rio de Janeiro State, Brazil, in September 26-28, 2002, has provided an excellent opportunity for the presentation and the discussion of the latest achievements and new trends of nuclear medicine techniques and radiopharmaceuticals for the clinical evaluation of inflammation, infection, oncology and therapy of diseases with radionuclides

  10. Short-lived radiopharmaceuticals for the diagnosis of ocular melanoma

    International Nuclear Information System (INIS)

    Packer, S.; Lambrecht, R.; Atkins, H.L.; Wolf, A.P.

    1974-01-01

    An experimental procedure has been established to evaluate radiopharmaceuticals for the specific purpose of melanoma detection by scintiscanning. By using the Greene melanoma in the hamster several labeled compounds were compared. Specifically the tumor uptake along with detailed analyses of uptake by various parts of the eye and body were determined in a hamster model. Of those short-lived radionuclides investigated 203 Pb-tris was the most promising as a non-invasive localizing agent for ocular melanoma and it should prove effective for ocular scintigraphy. (U.S.)

  11. Quality control protocols for radiodiagnosis agents and radiopharmaceuticals

    International Nuclear Information System (INIS)

    Robles, A.; Condor, M.; Caballero, J.; Morote, M.; Garcia, C.; Benites, M.

    1997-01-01

    Based on the compilation of pharmacopoeia methods, literature, manuals and other information developed in our laboratory, protocols have been prepared to carry out quality controls for radiodiagnosis agents (RDA), better known as kits and RDA labelled with Tc99m. Quality control protocols cover physicochemical and biological controls. Physicochemical controls described for RDA include physical characteristics, particle size and number, pH, chemical identification, humidity, tin II; whereas biological controls include sterility, acute toxicity and bacterial endotoxin determination (LAL). Physicochemical controls described for radiopharmaceuticals labelled with Tc99m are pH and radiochemical purity; while biological distribution is described as a biological control

  12. Production And Quality Control Of Radiopharmaceutical 18F-FDG

    International Nuclear Information System (INIS)

    Dinh Thi Bich Lieu; Nguyen Van Si; Vu Van Tien

    2011-01-01

    18 F-FDG is a radiopharmaceutical for imaging diagnosis with PET/CT in Nuclear Medicine. Criteria of injection pharmaceuticals are the highest standards. So, quality assurance and quality control must be followed very strictly. The selection of the procedure for 18 F-FDG has based on several criteria: high chemical efficiency, short synthesis time, toxic component free and etc. The quality control of 18 F-FDG consist many fields such as: nuclear physic (nuclear purity), radiochemistry (radionuclear purity, radiochemical purity), chemistry (chemical purity), radiation measurement (half life), microbiology (pyrogen, endotoxin), etc. which is following USP, BP or EP. (author)

  13. A Peltier thermal cycling unit for radiopharmaceutical synthesis

    International Nuclear Information System (INIS)

    McKinney, C.J.; Nader, M.W.

    2001-01-01

    We have investigated the use of Peltier devices to rapidly cycle the temperature of reaction vessels in a radiopharmaceutical synthesis system. Peltier devices have the advantage that they can be actively cooled as well as heated, allowing precise and rapid control of vessel temperatures. Reaction vessel temperatures of between -6 deg. C and 110 deg. C have been obtained with commercially available devices with reasonable cycle times. Two devices have been used as the basis for a general purpose, two-pot synthesis system for production of [ 11 C] compounds such as raclopride

  14. 68Ga-Based Radiopharmaceuticals: Production and Application Relationship

    Directory of Open Access Journals (Sweden)

    Irina Velikyan

    2015-07-01

    Full Text Available The contribution of 68Ga to the promotion and expansion of clinical research and routine positron emission tomography (PET for earlier better diagnostics and individualized medicine is considerable. The potential applications of 68Ga-comprising imaging agents include targeted, pre-targeted and non-targeted imaging. This review discusses the key aspects of the production of 68Ga and 68Ga-based radiopharmaceuticals in the light of the impact of regulatory requirements and endpoint pre-clinical and clinical applications.

  15. Fabrication of sterile experimental radiopharmaceuticals: technical and regulatory requirements

    International Nuclear Information System (INIS)

    Briand, S.

    2008-03-01

    The radiopharmaceuticals devoted to the biomedical research were the object of the directive 2001/20/C.E. transposition that defined again the conditions of implementation of biomedical research using drugs at human use, whom authorization is delivered by A.f.s.s.a.p.s.. In an other hand the law 2006-686 of the 13. june 2006 ( called law T.S.N.) has modified the regulatory dispositions relative to the radiation protection norms. These new dispositions allow to the health facilities to realize their research projects without difficulties for experimental drugs supply. (N.C.)

  16. Interaction between some disinfectants and Tcsup(99m)-radiopharmaceuticals

    International Nuclear Information System (INIS)

    Verbruggen, A.; Cleynhens, B.; Hoogmartens, M.; De Roo, M.

    1985-01-01

    Contamination of Tcsup(99m) sulphur colloid with small amounts of iodinated antiseptics has been described to result in the formation of free pertechnetate and excessive blood-pool activity upon injection. As far as we know similar or other interactions have not been reported for disinfectants that are effective by another mechanism than oxidizing activity. The present study has been set up to investigate the effect of small amounts of a wide variety of commonly available antiseptics on the radiochemical and biological behaviour of different Tcsup(99m) labelled radiopharmaceuticals. (Auth.)

  17. Guidance for nuclear medicine staff on radiopharmaceuticals drug interaction

    Directory of Open Access Journals (Sweden)

    Ralph Santos-Oliveira

    2009-12-01

    Full Text Available Numerous drug interactions related to radiopharmaceuticals take place every day in hospitals many of which are not reported or detected. Information concerning this kind of reaction is not abundant, and nuclear medicine staff are usually overwhelmed by this information. To better understand this type of reaction, and to help nuclear medicine staff deal with it, a review of the literature was conducted. The results show that almost all of radiopharmaceuticals marketed around the world present drug interactions with a large variety of compounds. This suggests that a logical framework to make decisions based on reviews incorporating adverse reactions must be created. The review also showed that researchers undertaking a review of literature, or even a systematic review that incorporates drug interactions, must understand the rationale for the suggested methods and be able to implement them in their review. Additionally, a global effort should be made to report as many cases of drug interaction with radiopharmaceuticals as possible. With this, a complete picture of drug interactions with radiopharmaceuticals can be drawn.Diversos casos de interações medicamentosas com radiofármacos ocorrem diariamente na rotina hospitalar, contudo muitos deles não são notificados ou mesmo percebidos. Informações a respeito desse tipo de reação não é abundante e os profissionais da medicina nuclear muitas vezes estão assoberbados por essas informações. De modo a entender esse tipo de reação e auxiliar a medicina nuclear a lidar com essa situação uma revisão da literatura foi realizada. Os resultados mostraram que a totalidade dos radiofármacos comercializados no mundo apresentam interação medicamentosa com uma enorme variedade de outros medicamentos. Dessa forma sugere-se que revisões sobre radiofármacos inclua um capítulo sobre efeitos adversos. Além disso, um esforço mundial para notificar efeitos adversos deve ser realizado, pois somente

  18. Quality assurance considerations related to in-house radiopharmaceutical preparations

    International Nuclear Information System (INIS)

    Finn, R.D.; Boothe, T.E.

    1990-01-01

    The Food and Drug Administration through its interpretation of the Food, Drug and Cosmetic Act with various amendments not only oversees the clinical investigation of new drugs, including short-lived radiopharmaceuticals but also monitors specific basic research protocols through the activities of the approved Radioactive Drug Research Committees. Concurrent with the technical improvements being made with positron emission tomographs is the increased availability of a variety of radiolabeled substrates possessing the unique potential to serve as indicators of in vivo alteration of biochemical processes. The syntheses of certain positron emitting radioligands with specific emphasis on the quality control procedures and current good manufacturing practices are discussed

  19. Radiopharmaceuticals good practices handbook: ARCAL XV radiopharmaceuticals control and production; Manual de buenas practicas radiofarmaceuticas: ARCAL XV produccion y control de radiofarmacos

    Energy Technology Data Exchange (ETDEWEB)

    Verdera Presto, Silvia [comp.; Universidad de la Republica, Facultad de ciencias, Centro de Investigaciones Nucleares, Montevideo (Uruguay)

    1999-12-31

    A safety practice of the therapeutics diagnostic proceeding in nuclear medicine require a permanent provide high quality radiopharmaceuticals manufacture. This work treat to give a guide for all radio pharmacies laboratories that produce,control, fraction and or dispense radiopharmaceuticals products, with attention hospitable radiopharmacy laboratory. Three chapters with recommendations in manufacture good practice in Hospital radiopharmacy, industrial centralized, bibliography and three annexe`s about clean area classification,standards work in laminar flux bell, and guarantee and cleaning areas

  20. An intelligent portal monitor for fast suppression of false positives due to radiopharmaceuticals

    International Nuclear Information System (INIS)

    Johnson, M.W.; Butterfield, K.B.

    1985-01-01

    Monitoring the movement of radioactive material through secure or sensitive areas may be complicated by the existence of unanticipated sources of radiation carried by individuals passing through the area. Typical of such sources are radiopharmaceuticals prescribed for a medical procedure. The authors report here on an apparatus designed to quickly discriminate between in-vivo radiopharmaceuticals and other nuclear materials, based on a pattern-recognition algorithm and microcomputer. Principles of operation are discussed, and the data base for the pattern-recognition algorithms is displayed. Operating experience with the apparatus in a trial location is also discussed. The apparatus correctly identifies in-vivo radiopharmaceuticals in over 80% of all trials; challenges with radioisotopes other than radiopharmaceuticals have led the apparatus, without exception, to reject the challenge isotope as incompatible with medical practice. The apparatus thus rapidly discriminates between individuals bearing radiopharmaceuticals and those bearing illicit sources, such as special nuclear materials

  1. The role of mathematical models in the optimization of radiopharmaceutical therapy

    International Nuclear Information System (INIS)

    Divgi, C.

    2001-01-01

    Mathematical models have been used in radiopharmaceutical therapy for over five decades. These have served to determine the amount of radioactivity required to treat disease, as in the therapy of hyperthyroidism with iodine-131, or, more frequently, to determine the largest amount of radioactivity that can be safely administered. Mathematical models are especially useful in the determination of fractionated radiopharmaceutical therapy. This review will briefly outline the historical development and current utility of mathematical models in radiopharmaceutical therapy, including thyroid disorders and radioimmunotherapy; and describe the potential of modeling in fractionated therapy. The extended application of such models to currently used radiopharmaceutical therapy based on indices of body mass or surface area, to alleviate toxicity and increase radiation dose to tumour, will be proposed. Finally, future applications of mathematical models in radiopharmaceutical therapy will be outlined. (author)

  2. Technical artifacts in chromatographic analysis of Tc-99m radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kowalsky, R.J.; Creekmore, J.R.

    1982-01-01

    Technical artifacts produced during chromatographic analysis of technetium radiopharmaceuticals were investigated. Such artifacts are, we found, caused by improper spotting and drying techniques; these in turn produce spuriously high impurities in Tc-99m complexes of DTPA, MDP, PPi, and GH. The ITLC-SG/acetone system produces considerable streaking of Tc-complex if the applied spot is large and not dried before development. This results in activity in the solvent front portion of the chromatographic strip indicating falsely high levels of pertechnetate impurity. Proper drying of the applied spot eliminates the artifact. The ITLC-SG/saline system yields falsely high, hydrolyzed-reduced technetium impurities if the spot is allowed to enter the solvent during development. Correct spot placement and size eliminate this problem. Strips that are allowed to dry in room air for several minutes may indicate considerable pertechnetate impurity on the chromatogram; yet this may not actually be present in the radiopharmaceutical vial. Drying spots rapidly with hot air or in a nitrogen atmosphere before development eliminates this problem

  3. The search for consistency in the manufacture of PET radiopharmaceuticals

    International Nuclear Information System (INIS)

    Finn, R.D.

    1999-01-01

    Nuclear Medicine is the specialty of medical imaging, which utilizes a variety of radionuclides incorporated into specific compounds for diagnostic imaging and therapeutic applications. During recent years, research efforts in this discipline have concentrated on the decay characteristics of particular radionuclides and the design of unique radiolabeled tracers necessary to achieve time-dependent molecular images. Various oncology applications have utilized specific PET and SPECT radiopharmaceuticals, which have allowed an extension from functional process imaging in tissue to pathologic processes and nuclide directed treatments. One of the most widely recognized advantages of positron emission tomography (PET) is its use of the attractive, positron-emitting biologic radiotracers that mimic natural substrates. However, a major disadvantage is that these substances are relatively short-lived and unable to be transported great distances. At this time, economic considerations and regulatory guidelines associated with the creation of a PET facility, as well as the operational costs of maintaining both the facility and the necessary procedural documentation, continue to create interesting strategic dilemmas. This commentary will focus on the current approach and anticipated impact of pending regulations, which relate to the manufacture and formulation of a variety of PET radiopharmaceuticals used in clinical research and patient management at Memorial Hospital. (author)

  4. HPLC-MS technique for radiopharmaceuticals analysis and quality control

    International Nuclear Information System (INIS)

    Macasek, F.; Buriova, E.; Bruder, P.; Vera-Ruiz, H.

    2003-01-01

    Potentialities of liquid chromatography with mass spectrometric detector (MSD) were investigated with the objective of quality control of radiopharmaceuticals; 2-deoxy-2-[ 18 F]fluoro-D-glucose (FDG) being an example. Screening of suitable MSD analytical lines is presented. Mass-spectrometric monitoring of acetonitrile-aqueous ammonium formate eluant by negatively charged FDG.HCO 2 - ions enables isotope analysis (specific activity) of the radiopharmaceutical at m/z 227 and 226. Kryptofix 222 provides an intense MSD signal of the positive ion associated with NH 4 + at m/z 394. Expired FDG injection samples contain decomposition products from which at least one labelled by 18 F and characterised by signal of negative ions at m/z 207 does not correspond to FDG fragments but to C5 decomposition products. A glucose chromatographic peak, characterised by m/z 225 negative ion is accompanied by a tail of a component giving a signal of m/z 227, which can belong to [ 18 O]glucose; isobaric sorbitol signals were excluded but FDG-glucose association occurs in the co-elution of separation of model mixtures. The latter can actually lead to a convoluted chromatographic peak, but the absence of 18 F makes this inconsistent. Quantification and validation of the FDG component analysis is under way. (author)

  5. The influence of stereoisomerism on the pharmacokinetics of Tc radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Hansen, L.; Taylor, A. [Atlanta, Emory Univ. School of Medicine, GA (United States). Dept. of Chemistry; Marzilli, L.G. [Atlanta, Emory Univ. School of Medicine, GA (United States). Dept. of Radiology

    1998-12-01

    The influence of stereoisomerism on the pharmacokinetics of Tc mono-oxo complexes is reviewed. Tc(V) mono-oxo complexes formed with N/S ligands have four donor groups from the ligands in an equatorial plane; the oxo ligand coordinates in an axial position. Stereoisomerism in Tc(V) mono-oxo complexes can be centered within the ligand (carbon atom in the chelate ring of ligating nitrogen of amine donors) or at the Tc. The metal center becomes chiral when an equatorial ligand has a head and a tail (i.e. the two ends of the ligand differ). All types of stereocenter can produce significantly different pharmacokinetic profiles for individual isomers. Thus, biological evaluation of separated stereoisomers is necessary to identify the optimal stereochemical configuration, particularly for radiopharmaceuticals targeted to receptor molecules with low specificity. Because of inter species variation, there is ultimately no substitute for human testing. Although it is possible that the increase in nonspecific binding of agents incorporating L- vs D-amino acids may more than offset any increased receptor binding, much more information is needed. Stereochemical factors can also lead to unpredictable differences in coordination geometry and thermodynamic preference of a single isomer; thus chemical characterization of stereo-isomers continues to be an important component of radiopharmaceutical development.

  6. KAERI's challenge to steady production of radioisotopes and radiopharmaceuticals

    International Nuclear Information System (INIS)

    Park, J.H.; Han, H.S.; Park, K.B.

    2000-01-01

    The Korea Atomic Energy Research Institute (KAERI) is a national organization in Korea, and has been doing many research and development works in radioisotope production and applications for more than 30 years. Now KAERI regularly produces radioisotopes (I-131, Tc-99m, Ho-166) for medical use and Ir-192 for industrial use. Various I-131 labeled compounds and more than 10 kinds of Tc-99m cold kits are also produced. Our multi-purpose reactor, named HANARO, has been operative since April of 1995. HANAKO is an open tank type reactor with 30 MW thermal capacity. This reactor was designed not only for research on neutron utilization but for production of radioisotopes. KAERI intended to maximize the radioisotope production capability. For this purpose, radioisotope production facilities (RIPF) have been constructed adjacent to the HANARO reactor building. There are four banks of hot cells equipped with manipulators and some of the hot cells were installed according to the KGMP standards and with clean rooms. In reviewing our RI production plan intensively, emphasis was placed on the development of new radiopharmaceuticals, development of new radiation sources for industrial and therapeutic use, and steady production of selected radioisotopes and radiopharmaceuticals. The selected items are Ho-166 based pharmaceuticals, fission Mo-99/Tc-99m generators. solution and capsules of I-131, and Ir-192 and Co-60 for industrial use. The status and future plan of KAERI's research and development program will be introduced, and will highlight programs for steady production. (author)

  7. The use of transducers for automated radiopharmaceutical synthesis procedures

    International Nuclear Information System (INIS)

    Ruth, T.J.; Adam, M.J.; Morris, D.; Jivan, S.; Tyldesley, S.

    1991-01-01

    There are essentially two reasons why a synthetic procedure for producing a radiopharmaceutical is automated. The First is to reduce radiation exposure and the second is to increase reliability. Reducing radiation exposure can be accomplished in a number of ways. The most common approaches include the use of: hotcells with manipulators, remotely controlled solenoid valves behind shielding, either a PC or a PLC to control the solenoid valves, or robotics. The question of reliability impacts on each of these methods differently. The use of a hotcell with manipulators requires a highly skilled operator and in general is not suitable for microchemistry and very short half-lives. The remotely controlled system is prone to operator error, for example activating the wrong valving sequence. The computer controlled system is dependent on a feedback system if it is to operate open-quotes intelligentlyclose quotes; and finally the robotic system is dependent on feedbacks, as well as, careful, set-up within the robotic coordinate system. The remainder of this paper will discuss the feedback loops, required for the automated/robotic chemistry associated with the synthesis of positron emitting radiopharmaceuticals

  8. Study of potential utility of new radiopharmaceuticals based on technetium-99m labeled derivative of glucose

    Science.gov (United States)

    Zeltchan, R.; Medvedeva, A.; Sinilkin, I.; Chernov, V.; Stasyuk, E.; Rogov, A.; Il'ina, E.; Larionova, L.; Skuridin, V.

    2016-08-01

    Purpose: to study the potential utility of 1-thio-D-glucose labeled with 99mTc for cancer imaging in laboratory animals. Materials and method: the study was carried out in cell cultures of normal CHO (Chinese hamster ovary cells CHO) and malignant tissues MCF-7 (human breast adenocarcinoma MCF-7). To evaluate the uptake of 99mTc-1-thio-D-glucose in normal and tumor tissue cells, 25 MBq of 1-thio-D-glucose labeled with 99mTc was added to the vials with 3 million cells and incubated for 30 min at room temperature. After centrifugation of the vials with cells, the supernatant was removed. The radioactivity in vials with normal and tumor cells was then measured. In addition, the study included 40 mice of C57B1/6j lines with tumor lesion of the right femur. For neoplastic lesions, Lewis lung carcinoma model was used. Following anesthesia, mice were injected intravenously with 25 MBq of 99mTc-1-thio-D-glucose. Planar scintigraphy was performed 15 minutes later in a matrix of 512x512 pixels for 5 min. Results: when measuring the radioactivity of normal and malignant cells after incubation with 99mTc-1-thio-D-glucose, it was found that the radioactivity of malignant cells was higher than that of normal cells. The mean values of radioactivity levels in normal and malignant cells were 0.3 ± 0.15 MBq and 1.07 ± 0.6 MBq, respectively. All examined animals had increased accumulation of 99mTc-1-thio-D-glucose at the tumor site. The accumulation of 99mTc-1-thio-D-glucose in the tumor was on average twice as high as compared to the symmetric region. Conclusion: The present study demonstrated that 99mTc-1-thio-D-glucose is a prospective radiopharmaceutical for cancer visualization. In addition, high accumulation of 99mTc-1-thio-D-glucose in the culture of cancer cells and in tumor tissue of animals demonstrates tumor tropism of the radiopharmaceutical.

  9. Experimental study of radiopharmaceuticals based on technetium-99m labeled derivative of glucose for tumor diagnosis

    Science.gov (United States)

    Zeltchan, R.; Medvedeva, A.; Sinilkin, I.; Bragina, O.; Chernov, V.; Stasyuk, E.; Rogov, A.; Il'ina, E.; Larionova, L.; Skuridin, V.; Dergilev, A.

    2016-06-01

    Purpose: to study the potential utility of 1-thio-D-glucose labeled with 99mTc for cancer imaging in laboratory animals. Materials and method: the study was carried out in cell cultures of normal CHO (Chinese hamster ovary cells CHO) and malignant tissues MCF-7 (human breast adenocarcinoma MCF-7). To evaluate the uptake of 99mTc-1-thio-D-glucose in normal and tumor tissue cells, 25 MBq of 1-thio-D-glucose labeled with 99mTc was added to the vials with 3 million cells and incubated for 30 minutes at room temperature. After centrifugation of the vials with cells, the supernatant was removed. Radioactivity in vials with normal and tumor cells was then measured. In addition, the study included 40 mice of C57B 1/6j lines with tumor lesion of the right femur. For neoplastic lesions, Lewis lung carcinoma model was used. Following anesthesia, mice were injected intravenously with 25MBq of 99mTc-1-thio-D-glucose. Planar scintigraphy was performed 15 minutes later in a matrix of 512x512 pixels for 5 minutes. Results: when measuring the radioactivity of normal and malignant cells after incubation with 99mTc-1-thio-D- glucose, it was found that the radioactivity of malignant cells was higher than that of normal cells. The mean values of radioactivity levels in normal and malignant cells were 0.3±0.15MBq and 1.07±0.6MBq, respectively. All examined animals had increased accumulation of 99mTc-1-thio- D-glucose at the tumor site. The accumulation of 99mTc-1-thio-D-glucose in the tumor was on average twice as high as compared to the symmetric region. Conclusion: The present study demonstrated that 99mTc-1-thio-D-glucose is a prospective radiopharmaceutical for cancer visualization. In addition, high accumulation of 99mTc-1-thio-D-glucose in the culture of cancer cells and in tumor tissue of animals demonstrates tumor tropism of the radiopharmaceutical.

  10. Study of potential utility of new radiopharmaceuticals based on technetium-99m labeled derivative of glucose

    Energy Technology Data Exchange (ETDEWEB)

    Zeltchan, R., E-mail: r.zelchan@yandex.ru; Medvedeva, A.; Sinilkin, I.; Chernov, V. [Tomsk Cancer Research Institute, Tomsk, 634050 (Russian Federation); Tomsk Polytechnic University, Tomsk, 634050 (Russian Federation); Stasyuk, E.; Rogov, A.; Il’ina, E.; Larionova, L.; Skuridin, V. [Tomsk Polytechnic University, Tomsk, 634050 (Russian Federation)

    2016-08-02

    Purpose: to study the potential utility of 1-thio-D-glucose labeled with {sup 99m}Tc for cancer imaging in laboratory animals. Materials and method: the study was carried out in cell cultures of normal CHO (Chinese hamster ovary cells CHO) and malignant tissues MCF-7 (human breast adenocarcinoma MCF-7). To evaluate the uptake of {sup 99m}Tc-1-thio-D-glucose in normal and tumor tissue cells, 25 MBq of 1-thio-D-glucose labeled with {sup 99m}Tc was added to the vials with 3 million cells and incubated for 30 min at room temperature. After centrifugation of the vials with cells, the supernatant was removed. The radioactivity in vials with normal and tumor cells was then measured. In addition, the study included 40 mice of C57B1/6j lines with tumor lesion of the right femur. For neoplastic lesions, Lewis lung carcinoma model was used. Following anesthesia, mice were injected intravenously with 25 MBq of {sup 99m}Tc-1-thio-D-glucose. Planar scintigraphy was performed 15 minutes later in a matrix of 512x512 pixels for 5 min. Results: when measuring the radioactivity of normal and malignant cells after incubation with {sup 99m}Tc-1-thio-D-glucose, it was found that the radioactivity of malignant cells was higher than that of normal cells. The mean values of radioactivity levels in normal and malignant cells were 0.3 ± 0.15 MBq and 1.07 ± 0.6 MBq, respectively. All examined animals had increased accumulation of {sup 99m}Tc-1-thio-D-glucose at the tumor site. The accumulation of {sup 99m}Tc-1-thio-D-glucose in the tumor was on average twice as high as compared to the symmetric region. Conclusion: The present study demonstrated that {sup 99m}Tc-1-thio-D-glucose is a prospective radiopharmaceutical for cancer visualization. In addition, high accumulation of {sup 99m}Tc-1-thio-D-glucose in the culture of cancer cells and in tumor tissue of animals demonstrates tumor tropism of the radiopharmaceutical.

  11. International symposium on trends in radiopharmaceuticals (ISTR-2005). Book of extended synopses

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-07-01

    Radiopharmaceuticals, along with imaging instrumentation, are the pillars that support the edifice of clinical nuclear medicine and the former is the major driver enabling investigations of molecular phenomena for better understanding of human disease and developing effective treatments. The growth of nuclear medicine has been intimately linked to availability of new radioisotopes and the discovery of new radiopharmaceuticals. The field of radiopharmaceuticals has witnessed continuous evolution thanks to the immense contributions of scientists from diverse disciplines such as radiochemistry, inorganic chemistry, organic chemistry, biochemistry, physiology and pharmacology. Several milestones can be cited in the trajectory of this growth, which include continuing development of a plethora of {sup 99}mTc radiopharmaceuticals, automated synthesis of {sup 18}F labelled compounds, labelled peptides for accurate mapping of metastasis and the advances in radionuclide therapy. The International Symposium on Trends in Radiopharmaceuticals, ISTR-2005, under the auspices of International Atomic Energy Agency, will provide scientists and professionals working in the field of radiopharmaceuticals and related sciences an opportunity to review the exciting developments in the field. The International Atomic Energy Agency has been organizing such Symposia on Radiopharmaceuticals since 1973 and the last one was held in Lisbon, Portugal, in 1998.

  12. Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Dumas, Cecile

    2010-07-01

    Preparation of radiopharmaceuticals for injection involves adherence to regulations on radiation protection as well as to appropriate rules of working under aseptic conditions, which are covered by these guidelines on Good Radiopharmacy Practice (GRPP). The handling of radiopharmaceuticals is potentially hazardous. The level of risk depends in particular upon the types of radiation emitted and the half-lives of the radioactive isotopes. Particular attention must be paid to the prevention of cross-contamination, and to waste disposal. A continuous assessment of the effectiveness of the Quality Assurance system is essential to prove that the procedures applied in the Radiopharmacy Department lead to the expected quality. Clinical trials with new radiopharmaceuticals should follow these regulations on cGRPP as well as the Guideline on Good Clinical Practice. As there is a considerable difference in complexity in preparing 'classical' radiopharmaceuticals in 'kit' procedures and producing radiopharmaceuticals by distinct chemical procedures (Positron Emission Tomography (PET) Radiopharmaceuticals, in house prepared radiopharmaceuticals including in house prepared kits) these guidelines have been divided in two parts (A and B) respecting these differences

  13. The application of the 'ten-day rule' in radiopharmaceutical investigations

    International Nuclear Information System (INIS)

    Ellis, R.E.; Nordin, B.E.C.; Tothill, P.; Veall, N.

    1977-01-01

    The working party first classified subjects who are investigated using radiopharmaceuticals into three groups, being (a) patients and other subjects who are asked to volunteer as controls for research studies, (b) patients on whom research investigations are being conducted which are relevant to their clinical condition but which are not strictly necessary for their management, and (c) patients on whom investigations are required for their proper management. The application of the 'ten-day rule' in relation to the use of radiopharmaceuticals is complicated by the fact that the total radiation dose is received over a time given by the effective life of the radiopharmaceutical in the organ, which may be a substantial part or even longer of the menstrual cycle. The activities of the radiopharmaceuticals normally administered are tabulted together with their effective half-lives and resulting gonad doses, and those radiopharmaceuticals requiring consideration of the implementation of the 'ten-day rule' for patients in groups (b) and (c) are identified. When the administration of therapeutic quantities of radiopharmaceuticals is being contemplated it is particularly important to take into account the applicability or otherwise of the 'ten-day rule'. It is recommended that the 'ten-day rule' should be strictly applied to all radiopharmaceutical administrations to women of child-bearing age who are volunteers for research purposes (group(a)). (U.K.)

  14. Limulus test for pyrogens and radiometric sterility tests on radiopharmaceuticals. Part of a coordinated programme

    International Nuclear Information System (INIS)

    Gopal, N.G.S.

    1976-10-01

    Sterility testing of radiopharmaceuticals prepared at BARC were carried out using the radiometric technique (Radiometric detection of the metabolic product 14 Co 2 ). Batches of different radiopharmaceuticals were tested for pyrogen using the limulus lysate method and the results were compared with the rabbit method. The results of sterility test on 202 batches of 19 different radiopharmaceuticals show that the radiometric method can be used for sterility testing of radiopharmaceuticals labelled with 35 S, 51 Cr, 57 Co, 59 Fe, 82 Br, 86 Rb, sup(99m)Tc, sup(113m)In, 125 I and 169 Yb. The radiometric test proves to be more rapid than the conventional one for the sterility testing of such radiopharmaceuticals. Detection time is between 6-21 hours. In the case of 131 I-labelled radiopharmaceuticals and in the case of chlormerodrin-Hg-203, it was found an interference due to volatile species (sup(131m)Xe in the case of 131 I and some volatile mercury form in the case of chlormerodrin). In these cases it would be possible to carry out the radiometric sterility test after separation of the microorganisms from the radioactive material (by filtration). The limulus lysate method can be employed for control of various pyrogen-prone raw materials and radiopharmaceuticals. Such method is the only method at present available for detecting the low level pyrogen contamination in intrathecal injections. The limulus test is more rapid than the rabbit test

  15. International symposium on trends in radiopharmaceuticals (ISTR-2005). Book of extended synopses

    International Nuclear Information System (INIS)

    2005-01-01

    Radiopharmaceuticals, along with imaging instrumentation, are the pillars that support the edifice of clinical nuclear medicine and the former is the major driver enabling investigations of molecular phenomena for better understanding of human disease and developing effective treatments. The growth of nuclear medicine has been intimately linked to availability of new radioisotopes and the discovery of new radiopharmaceuticals. The field of radiopharmaceuticals has witnessed continuous evolution thanks to the immense contributions of scientists from diverse disciplines such as radiochemistry, inorganic chemistry, organic chemistry, biochemistry, physiology and pharmacology. Several milestones can be cited in the trajectory of this growth, which include continuing development of a plethora of 99 mTc radiopharmaceuticals, automated synthesis of 18 F labelled compounds, labelled peptides for accurate mapping of metastasis and the advances in radionuclide therapy. The International Symposium on Trends in Radiopharmaceuticals, ISTR-2005, under the auspices of International Atomic Energy Agency, will provide scientists and professionals working in the field of radiopharmaceuticals and related sciences an opportunity to review the exciting developments in the field. The International Atomic Energy Agency has been organizing such Symposia on Radiopharmaceuticals since 1973 and the last one was held in Lisbon, Portugal, in 1998

  16. Influence of Storage Temperature on Radiochemical Purity of 99mTc-Radiopharmaceuticals.

    Science.gov (United States)

    Uccelli, Licia; Boschi, Alessandra; Martini, Petra; Cittanti, Corrado; Bertelli, Stefania; Bortolotti, Doretta; Govoni, Elena; Lodi, Luca; Romani, Simona; Zaccaria, Samanta; Zappaterra, Elisa; Farina, Donatella; Rizzo, Carlotta; Giganti, Melchiore; Bartolomei, Mirco

    2018-03-15

    The influence of effective room temperature on the radiochemical purity of 99m Tc-radiopharmaceuticals was reported. This study was born from the observation that in the isolators used for the preparation of the 99m Tc-radiopharmaceuticals the temperatures can be higher than those reported in the commercial illustrative leaflets of the kits. This is due, in particular, to the small size of the work area, the presence of instruments for heating, the continuous activation of air filtration, in addition to the fact that the environment of the isolator used for the 99m Tc-radiopharmaceuticals preparation and storage is completely isolated and not conditioned. A total of 244 99m Tc-radiopharmaceutical preparations (seven different types) have been tested and the radiochemical purity was checked at the end of preparation and until the expiry time. Moreover, we found that the mean temperature into the isolator was significantly higher than 25 °C, the temperature, in general, required for the preparation and storage of 99m Tc-radiopharmaceuticals. Results confirmed the radiochemical stability of radiopharmaceutical products. However, as required in the field of quality assurance, the impact that different conditions than those required by the manufacturer on the radiopharmaceuticals quality have to be verified before human administration.

  17. Quality assessment of radiopharmaceuticals in nuclear medicine services at Northeast states, Brazil

    International Nuclear Information System (INIS)

    Andrade, Wellington Gomes de

    2012-01-01

    The radiopharmaceuticals are used in the field nuclear medicine services (NMS) as tracer in the diagnoses and treatment of many diseases. Radiopharmaceuticals used in nuclear medicine and usually have a minimum of pharmacological effect. The procedures for labelling Radiopharmaceuticals should be observed in order to minimize risks to patients, employees and individuals from the public, and to be administered in humans, must be sterile and free of pyrogens and possess elements all measures of quality controls required a conventional drug. The 'Agencia Nacional de Vigilancia Sanitaria (ANVISA)' in its 'Resolucao de Diretoria Colegiada' (RDC) No. 38 of June 4 th 2008, decided that the NMS must perform quality control in the generators eluate and radiopharmaceuticals according to recommendations of manufacturers and scientific evidence accepted by ANVISA. Thus, this study proposes to evaluate the quality of the generator 99M o- 99m Tc eluate and radiopharmaceuticals labeled with 99m Tc used in most NMS of some states in the Northeast, in relation to radionuclide, chemical, radiochemical purity and pH and promote the inclusion of procedure for quality control of radiopharmaceuticals in routine NMS. The results show that 90% radionuclidic purity, 98.2% purity chemical and radiochemical purity of 46% and 100% of the eluates are in agreement with international pharmacopoeias; already radiopharmaceuticals showed 82.6% purity and all radiochemical pH values are also in accordance with international pharmacopoeias. Even with so many positive results, staff the majority of MNS was not able to perform the quality control of the eluates and radiopharmaceuticals. Showing the importance of implementing of quality control programs of the eluates and radiopharmaceuticals in nuclear medicine. (author)

  18. Sterile kits for the preparation of radiopharmaceuticals: some basic quality control considerations

    International Nuclear Information System (INIS)

    Briner, W.H.

    1975-01-01

    Quality control concepts involved in the formulation of radiopharmaceutical kits, as well as all other radiopharmaceuticals, are meant to protect both the patients who receive these products and the practitioners of nuclear medicine who use these products in their practice. These concepts include the adequacy of site and facilities in which these products are formulated, the level of training and experience of personnel responsible for the formulation of the products, quality assurance procedures employed to monitor the acceptability of products, and, finally, a professional dedication to excellence in all these matters. The absence of any of these in a nuclear medicine or radiopharmaceutical program will result in almost certain disaster

  19. Leading safety performance indicators for resilience assessment of radiopharmaceuticals production process

    Energy Technology Data Exchange (ETDEWEB)

    Grecco, Claudio H.S.; Santos, Isaac J.A.L.; Carvalho, Paulo V.R., E-mail: grecco@ien.gov.b, E-mail: luquetti@ien.gov.b, E-mail: paulov@ien.gov.b [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil). Div. de Instrumentacao e Confiabilidade Humana; Vidal, Mario C.R., E-mail: mvidal@ergonomia.ufrj.b [Coordenacao dos Programas de Pos-Graduacao de Engenharia (PEP/COPPE/UFRJ), Rio de Janeiro, RJ (Brazil). Programa de Engenharia de Producao. Grupo de Ergonomia e Novas Tecnologias (GENTE)

    2011-07-01

    Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzyl guanidine is used in the diagnosis of cardiac diseases, and the fluorodeoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuro psychiatry. This paper presents a leading safety performance indicators framework to assess the resilience of radiopharmaceuticals production processes. The organizations that use resilience indicators will be able to pro actively evaluate and manage safety. (author)

  20. Leading safety performance indicators for resilience assessment of radiopharmaceuticals production process

    International Nuclear Information System (INIS)

    Grecco, Claudio H.S.; Santos, Isaac J.A.L.; Carvalho, Paulo V.R.

    2011-01-01

    Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzyl guanidine is used in the diagnosis of cardiac diseases, and the fluorodeoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuro psychiatry. This paper presents a leading safety performance indicators framework to assess the resilience of radiopharmaceuticals production processes. The organizations that use resilience indicators will be able to pro actively evaluate and manage safety. (author)

  1. Stannous ion quantitation in sup(99m)Tc-radiopharmaceutical kits

    International Nuclear Information System (INIS)

    Chervu, L.R.; Vallabhajosyula, B.; Mani, J.; Chun, S.B.; Blaufox, M.D.

    1982-01-01

    A simple and inexpensive method for the estimation of stannous ion, Sn(II), in radiopharmaceutical kits is described. The method used is a potentiometric titration of Sn(II) in 1 N HCl medium, using potassium iodate as the oxidizing agent in an atmosphere of nitrogen. The apparatus includes a pH meter, a platinum electrode, and a simple titration cell. Several commonly used radiopharmaceutical kits were analyzed for their Sn(II) content using this method. These studies indicate that the procedure can be used, as a routine quantitative test for the Sn(II) content of various sup(99m)Tc-labeled radiopharmaceuticals. (orig.)

  2. Analytical techniques for the determination of radiochemical purity of radiopharmaceuticals prepared from kits. Pt. III

    International Nuclear Information System (INIS)

    McLean, J.R.; Rockwell, L.J.; Welsh, W.J.

    1982-01-01

    The evaluation of efficacy of commercially available kits used for the preparation of radiopharmaceuticals is one aspect of the Radiation Protection Bureau's radiopharmaceutical quality control program. This report describes some of the analytical methodology employed in the program. The techniques may be of interest to hospital radiopharmacy personnel since many of the tests can be performed rapidly and with a minimum of special equipment, thus enabling the confirmation of radiopharmaceutical purity prior to patient administration. Manufacturers of kits may also be interested in learning of the analytical methods used in the assessment of their products

  3. Uncertainty sources in radiopharmaceuticals clinical studies; Fontes de incertezas em estudos clinicos com radiofarmacos

    Energy Technology Data Exchange (ETDEWEB)

    Degenhardt, Aemilie Louize; Oliveira, Silvia Maria Velasques de, E-mail: silvia@cnen.gov.br, E-mail: amilie@bolsista.ird.gov.br [Instituto de Radioprotecao e Dosimetria, (IRD/CNEN-RJ), Rio de Janeiro, RJ (Brazil)

    2014-07-01

    The radiopharmaceuticals should be approved for consumption by evaluating their quality, safety and efficacy. Clinical studies are designed to verify the pharmacodynamics, pharmacological and clinical effects in humans and are required for assuring safety and efficacy. The Bayesian analysis has been used for clinical studies effectiveness evaluation. This work aims to identify uncertainties associated with the process of production of the radionuclide and radiopharmaceutical labelling as well as the radiopharmaceutical administration and scintigraphy images acquisition and processing. For the development of clinical studies in the country, the metrological chain shall assure the traceability of the surveys performed in all phases. (author)

  4. Analytical techniques for the determination of radiochemical purity of radiopharmaceuticals prepared from kits

    International Nuclear Information System (INIS)

    McLean, J.R.; Rockwell, L.J.; Welsh, W.J.

    1977-01-01

    The evaluation of efficacy of commercially available kits used for the preparation of radiopharmaceuticals is one aspect of the Radiation Protection Bureau's radiopharmaceutical quality control program. This report describes some of the analytical methodology employed in the program. The techniques may be of interest to hospital radiopharmacy personnel as many of the tests can be performed rapidly and with a minimum of special equipment, thus enabling the confirmation of radiopharmaceutical purity prior to patient administration. Manufacturers of kits may also be interested in learning of the analytical methods used in the assessment of their products. (auth)

  5. Results of the quality assurance testing program for radiopharmaceuticals 1995

    International Nuclear Information System (INIS)

    Baldas, J.; Binnyman, J.; Ivanov, Z.; Lauder, R.

    1996-07-01

    The results of the quality assurance testing conducted by the Australian Radiation Laboratory is summarised. Overall 111 batches of 27 different types of radiopharmaceuticals were tested on samples obtained through normal commercial channels. Failure to meet full specifications was observed in 10 of the 111 batches. All technetium-99m cold kits were reconstituted according to the directions in the package insert using sodium pertechnetate ( 99m Tc) injection. Radionuclidic purity has been determined at the calibration time, except for Thallous [ 201 Tl] Chloride injection where the highest impurity level up to product expiry is quoted. Non-compliance of the vial label was observed in one of the ten batches failing specification and was the sole cause of product failure for this batch. Vial label non-compliance consisted of, absence of volume in the vial. Six batches failed the biodistribution test but in no case did this involve failure of the distribution for the target organs. tabs

  6. Sm-153 EDTMP (ethylene diamine tetramethylene phosphonic acid) radiotherapeutic radiopharmaceutical

    International Nuclear Information System (INIS)

    Rehir Dahalan; Wan Anuar Wan Awang

    1999-01-01

    This work has utilized the technology used in the design of the diagnostic radiopharmaceuticals, which enabled optimum delivery of, the gamma emitting radionuclide to the target organs, enhancing the image of organ of interest. Optimal delivery of radiotherapeutic agents, minimizes the dose to the non target organs, whilst delivering destructive beta emitting radionuclide to target cancerous tissues with the hope of slowing down or completely ablating its growth. This work had been in establishing the parameters in the optimal production of Sm-153 using the MINT Research Reactor (MINTRR). This radionuclide, was then labeled to the ethylene diamine tetramethylene phosphoric acid (EDTMP) ligand, a bone-seeking complex. The results of this work have established the most suitable target form, the optimum labeling conditions and the necessary parameters to enhance the biodistribution of the Sm-153 EDTMP complex in the bone of the animal model, thus similarly in human. (author)

  7. Study of a new radiometric sterility test in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Sanchez P, A.R.

    1976-01-01

    A new radiometric method is studied for the determination of sterility. It is based on a culture marked with carbon-14 and the measurement by liquid scintillation of the radioactivity of the gaseous products released after a short period of incubation. The studied samples consisted in nonradioactive solutions and different radiopharmaceuticals, through a regulated current of nitrogen there is a transportation of gaseous and volatile products produced in each flask, which were received in a liquid scintillation vial. The experimental data permit to conclude that through the radiometric method the results can be obtained after 24 hours or less of incubation, instead of a period of several days which was necessary with the traditional process. Due to the sensitivity of the method it is possible to inoculate a minimum volume of sample, this is important in the case of the preparation of little parts for injection as it occurs generally with the pharmaceuticals. (author)

  8. Phenolic aminocarboxylic acids as gallium-binding radiopharmaceuticals

    Energy Technology Data Exchange (ETDEWEB)

    Hunt, F.C.

    1984-06-01

    The phenolic aminocarboxylic acids ethylenediamine di (o-hydroxyphenylacetic acid) (EDDHA) and N,N'-bis (2-hydroxybenzyl) ethylenediamine N,N'-diacetic acid (HBED) form gallium complexes having high stability constants which enable them to resist exchange of gallium with plasma transferrin. /sup 67/Ga complexes were synthesized with these ligands, placing substituent groups in the phenolic ring to direct excretion via the renal or hepatobiliary route. The amount of /sup 67/Ga-Br-EDDHA excreted via the hepatobiliary route was comparable with that of some of the sup(99m)Tc agents. Excretion of /sup 67/Ga-Br-HBED was similar but with delayed transit from the liver. /sup 67/Ga COOH-EDDHA was excreted exclusively via the renal route. These findings provide a basis for developing new /sup 67/Ga or /sup 68/Ga radiopharmaceuticals, the latter for use in positron emission tomography, using these phenolic aminocarboxylates.

  9. Phenolic aminocarboxylic acids as gallium-binding radiopharmaceuticals

    International Nuclear Information System (INIS)

    Hunt, F.C.

    1984-01-01

    The phenolic aminocarboxylic acids ethylenediamine di [o-hydroxyphenylacetic acid] (EDDHA) and N,N'-bis [2-hydroxybenzyl] ethylenediamine N,N'-diacetic acid (HBED) form gallium complexes having high stability constants which enable them to resist exchange of gallium with plasma transferrin. 67 Ga complexes were synthesized with these ligands, placing substituent groups in the phenolic ring to direct excretion via the renal or hepatobiliary route. The amount of 67 Ga-Br-EDDHA excreted via the hepatobiliary route was comparable with that of some of the sup(99m)Tc agents. Excretion of 67 Ga-Br-HBED was similar but with delayed transit from the liver. 67 Ga COOH-EDDHA was excreted exclusively via the renal route. These findings provide a basis for developing new 67 Ga or 68 Ga radiopharmaceuticals, the latter for use in positron emission tomography, using these phenolic aminocarboxylates. (orig.) [de

  10. Phenolic aminocarboxylic acids as gallium-binding radiopharmaceuticals.

    Science.gov (United States)

    Hunt, F C

    1984-06-01

    The phenolic aminocarboxylic acids ethylenediamine di [o-hydroxyphenylacetic acid] (EDDHA) and N,N'-bis [2-hydroxybenzyl] ethylenediamine N,N'-diacetic acid (HBED) form gallium complexes having high stability constants which enable them to resist exchange of gallium with plasma transferrin. 67Ga complexes were synthesized with these ligands, placing substituent groups in the phenolic ring to direct excretion via the renal or hepatobiliary route. The amount of 67Ga-Br-EDDHA excreted via the hepatobiliary route was comparable with that of some of the 99mTc agents. Excretion of 67Ga-Br-HBED was similar but with delayed transit from the liver. 67Ga COOH-EDDHA was excreted exclusively via the renal route. These findings provide a basis for developing new 67Ga or 68Ga radiopharmaceuticals, the latter for use in positron emission tomography, using these phenolic aminocarboxylates.

  11. Results of the quality assurance testing program for radiopharmaceuticals 1995

    Energy Technology Data Exchange (ETDEWEB)

    Baldas, J.; Binnyman, J.; Ivanov, Z.; Lauder, R.

    1996-07-01

    The results of the quality assurance testing conducted by the Australian Radiation Laboratory is summarised. Overall 111 batches of 27 different types of radiopharmaceuticals were tested on samples obtained through normal commercial channels. Failure to meet full specifications was observed in 10 of the 111 batches. All technetium-99m cold kits were reconstituted according to the directions in the package insert using sodium pertechnetate ( {sup 99m}Tc) injection. Radionuclidic purity has been determined at the calibration time, except for Thallous [{sup 201}Tl] Chloride injection where the highest impurity level up to product expiry is quoted. Non-compliance of the vial label was observed in one of the ten batches failing specification and was the sole cause of product failure for this batch. Vial label non-compliance consisted of, absence of volume in the vial. Six batches failed the biodistribution test but in no case did this involve failure of the distribution for the target organs. tabs.

  12. Determination of stannous tin in radiopharmaceutical cold kits

    International Nuclear Information System (INIS)

    Farrant, A.J.

    1979-01-01

    Two methods for determining stannous tin in 'cold kits', used for the preparation of Tc-99m labelled radiopharmaceuticals, have been developed. Both are based on the direct titration of the Sn2 in solution. In the first method titration is with N-bromosuccinimide. Of the materials commonly used as cold kits only albumin has been found to interfere with the determination. The second method is a standard iodometric titration in which starch is used as indicator. None of the materials tested interfere with this procedure. The N-bromosuccinimide method is the method of choice as the re-agent, a solid, can be used without prior standardization. Iodine solution must be standardized daily. The paper describes in detail the methods used and gives examples of kits in which the Sn2 levels have been determined using the described procedures

  13. Compartmental analysis to predict biodistribution in radiopharmaceutical design studies

    Energy Technology Data Exchange (ETDEWEB)

    Lima, Marina F.; Pujatti, Priscilla B.; Araujo, Elaine B.; Mesquita, Carlos H. [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)], e-mail: mflima@ipen.br

    2009-07-01

    The use of compartmental analysis allows the mathematical separation of tissues and organs to determinate the concentration of activity in each fraction of interest. Although the radiochemical purity must observe Pharmacopoeia specification (values upper 95%), very lower contains of free radionuclides could contribute significantly as dose in the neighborhood organs and make tumor up take studies not viable in case of radiopharmaceutical on the basis of labeled peptides. Animal studies with a product of Lutetium-177 labeled Bombesin derivative ({sup 177}Lu-BBNP) developed in IPEN-CNEN/SP and free Lutetium-177 developed in CNEA/EZEIZA was used to show how subtract free {sup 177}Lu contribution over {sup 177}Lu-BBNP to estimate the radiopharmaceutical potential as diagnosis or therapy agent. The first approach of the studies included the knowledge of chemical kinetics and mimetism of the Lutetium and the possible targets of the diagnosis/therapy to choose the possible models to apply over the sampling standard methods used in experimental works. A model with only one physical compartment (whole body) and one chemical compartment ({sup 177}Lu-BBNP) generated with the compartmental analysis protocol ANACOMP showed high differences between experimental and theoretical values over 2.5 hours, in spite of the concentration of activity had been in a good statistics rang of measurement. The values used in this work were residence time from three different kinds of study with free {sup 177}Lu: whole body, average excretion and maximum excretion as a chemical compartment. Activity concentration values as time function in measurements of total whole body and activity measurement in samples of blood with projection to total circulating blood volume with {sup 177}Lu-BBNP. Considering the two sources of data in the same modeling a better consistence was obtained. The next step was the statistic treatment of biodistribution and dosimetry in mice (Balb C) considering three chemical

  14. Radiation protection optimization in practices for radiopharmaceuticals production at IEN

    International Nuclear Information System (INIS)

    Santos, Osvaldir Paulo dos

    2004-06-01

    This works has arisen from the need of updating radiological protection procedures, creating new ones and training qualified personnel to perform radiological protection duties in a nuclear facility. The main purpose of the research was to assess and minimize gamma and neutron dose rates emitted during the production and handling of radiopharmaceuticals at IEN/DIRA. A mobile measurements system (SMMG-N) was developed for on-site measurements. This system has proven to be more handy than the equipment formerly used for for this task. It has also proven to reduce the measurements uncertainties and to allow for the standardization of assessment procedures. He dose rates calculated using the data provided by this system have been compared with results obtained otherwise and good agreement was observed between them. This study has confirmed the need to improve the radiation shielding of KIPROS target-chamber and target vault in order to meet the radiological principles of dose rate limitation and optimization. (author)

  15. Adverse reactions to radiopharmaceuticals. United Kingdom 1977-1983

    International Nuclear Information System (INIS)

    Keeling, D.H.

    1984-01-01

    Details of reports to the UK Adverse Reaction Reporting Scheme for the years 1977-1983 are given. These show a changing pattern since earlier reports, in part due to the discontinuance of older radiopharmaceuticals and changes in quality control measures, but also to the introduction of methylene diphosphonate for bone imaging which has accounted for nearly half of our more recent reports. Colloids for reticulo-endothelial (liver) scans account for about one third of this series. The great majority of reactions are of an idiosyncratic hypersensitive nature and none due to sterility problems or pyrogens. Accurate incidence figures are difficult to obtain but including even the trivial forms of reaction, we estimate a reaction rate of between 1:1000 and 1:10,000 in vivo nuclear medicine procedures, a figure considerably higher than most previous surveys have suggested. (author)

  16. Determination of tin(II) in reagents for radiopharmaceuticals

    International Nuclear Information System (INIS)

    Morosanova, E.I.; Loginova, K. A.; Epstein, N.B.

    2003-01-01

    The goal of this work is to elaborate a procedure for rapid and simple determination of tin(II) in reagents for preparation of radiopharmaceuticals based on a system albumin-Tc-99m. Original test tools for the determination of various analytes have been suggested in our lab based on the use of small glass tubes (1-2 mm i.d. - 50-70 mm) filled with indicator powders containing suitable immobilized chromogenic reagents. An analytical signal (a length of colored zone which is proportional to the concentration of an analyte) is detected after a sample passing through the indicator tube. Heteropoly compounds are well-known analytical reagents for a photometric determination of various reductants. For elaboration of indicator tubes abilities of Mo,P-heteropoly compounds to give deeply colored blue compounds after reduction were used. (authors)

  17. Radiation protection optimization in practices for radiopharmaceuticals production at IEN

    International Nuclear Information System (INIS)

    Santos, P. dos; Delgado, Jose U.; Cardoso, Domingos D'Oliveira

    2005-01-01

    This work has arisen from the need of updating radiological protection procedures, creating new ones and training qualified personal to perform radiological protection duties in a nuclear facility. The main purpose of the research was to assess and minimize gamma and neutron dose rates emitted during the production and handling of radiopharmaceuticals at IEN/DIRA. A mobile measurements system (SMMG-N) was developed for on-site measurements. This system has proven to be handier than the equipment formerly used for this task. It has also proven to define the measurements uncertainties and to allow for the standardization of assessment procedures. Here dose rates calculated using the data provided by this system have been compared with results obtained otherwise and good agreement was observed between them. This study has confirmed the need to improve the radiation shielding of target-chamber and target vault in order to meet the radiological principles of dose rate limitation and optimization. (author)

  18. Assay Validation For Quantitation of Sn 2+ In Radiopharmaceutical Kits

    International Nuclear Information System (INIS)

    Muthalib, A; Ramli, Martalena; Herlina; Sarmini, Endang; Suharmadi; Besari, Canti

    1998-01-01

    An assay validation for quantitation of Sn2+ in radiopharmaceutical kits based on indirect iodometric titration is described. The method is based on the oxidation of sn2+ using a known excess of iodine and the excess unreacted iodine titrated with thiosulphate. Typical analytical parameters considered in this assay validation are precision, accuracy, selectivity or specificity, range, and linearity. The precision of the analytical method is quit good represented by coefficient of variance in range of 1.0% to 6.9 %, for 10 runs of analysis except one analysis shows the coefficient of 10.2 %. The method has an accuracy of 95.6 % - 99 % as percent recoveries at theoretical Sn2+ amounts of 463 μg to 2318μg

  19. Radiopharmaceutical activities administered for paediatric nuclear medicine procedures in Australia

    International Nuclear Information System (INIS)

    Towson, J.E.; Smart, R.C.; Rossleigh, M.A.; Children's Hospital, Randwick, NSW

    2000-01-01

    A survey of radiopharmaceutical activities used at the eight hospital centres specialising in paediatric nuclear medicine in Australia was conducted in 1999-2000 by the Australian and New Zealand Society of Nuclear Medicine and the Australasian Radiation Protection Society. Data on the maximum and minimum administered activities was obtained for 43 paediatric imaging procedures. The maximum values were significantly less than the corresponding Reference Activities for adults determined in a previous study. Activities for individual patients are calculated using surface area scaling at five centres and body weight scaling at three centres. The median values of A max and A min are recommended as Paediatric Reference Activities. The effective dose to patients of various sizes for the Paediatric Reference Activities and both methods of scaling was calculated for each procedure. Copyright (2000) Australasian Radiation Protection Society Inc

  20. Effect of applied potential on electrochemically reduced technetium diphosphonate radiopharmaceuticals

    International Nuclear Information System (INIS)

    Martin, J.L. Jr.; Heineman, W.R.; Deutsch, E.

    1987-01-01

    Technetium diphosphonate radiopharmaceuticals continue to play a major role in diagnostic nuclear medicine. Their ability to provide both structural and functional information provides a unique advantage which even the more recent imaging techniques cannot provide. The Tc-99m isotope possesses nuclear decay characteristics which allow maximum organ imaging following intravenous injection while delivering a minimal radiation burden to the patient. Due to the diphosphonate ligands' strong affinity for bone, Tc-99m diphosphonate complexes are routinely used for the determination of bone abnormalities such as cancerous tumors. Electrochemical reduction provides the additional parameter needed to increase the yield of a single component. This work presents the effect of varying the applied potential of the mercury pool electrode at selected pH values. The result of this variation in applied potential is tracked by anion exchange chromatographic separation based on the negatively charged Tc-diphosphonate complexes. These chromatograms are compared to those obtained by standard chemical reduction

  1. Occupational exposure in the production of radiopharmaceuticals in Cuba

    International Nuclear Information System (INIS)

    Amador, Z. H.; Soria, M. A.

    2016-01-01

    The aim of this paper is to show the experiences in controlling occupational exposure production of radiopharmaceuticals in the Isotope Center (CENTIS) of the Republic of Cuba. data corresponding period 1996-2014 to 896 records are processed. The percentage distributions of the annual effective dose (E), the equivalent dose in the hands (Hp (0.07)) and the equivalent dose in crystalline (Hp (3)), are presented. The annual performance of the average values ​​of these dose quantities is plotted. The results of the internal dosimetry are processed. Annual activities manipulated radioisotopes greater contribution and its relation to the distribution of the collective dose directly linked S of staff, they are evaluated. The ALARA principle is implemented and maintained, based on qualitative and quantitative analysis, as appropriate. The (63-98)% of workers are monitored to E and the (80-100)% for Hp (0.07) and Hp (3), receives less than 10% of annual exposure limits. Groups of workers Radiopharmacy and Inspection and Testing are the greatest contribution to the collective dose, whose S to E equal to or greater than 2 mSv is the (9-62)% of total annual S. The maximum value of S is 98.3 mSv recorded man-1 and this occurs in 2011, however the highest value of 99Mo activity is handled in 2012 and a later year for 131I. They are identified as the most effective means for optimizing radiation safety the use of electronic dosimeters, internal shields process in hot cells and glove boxes and shields for collection of radioactive waste. a reduction in personnel exposure between (10-27)% is obtained. It is shown that exposure of workers in the production of radiopharmaceuticals in Cuba is acceptably low. (author)

  2. Effect of blood activity on dosimetric calculations for radiopharmaceuticals

    Science.gov (United States)

    Zvereva, Alexandra; Petoussi-Henss, Nina; Li, Wei Bo; Schlattl, Helmut; Oeh, Uwe; Zankl, Maria; Graner, Frank Philipp; Hoeschen, Christoph; Nekolla, Stephan G.; Parodi, Katia; Schwaiger, Markus

    2016-11-01

    The objective of this work was to investigate the influence of the definition of blood as a distinct source on organ doses, associated with the administration of a novel radiopharmaceutical for positron emission tomography-computed tomography (PET/CT) imaging—(S)-4-(3-18F-fluoropropyl)-L-glutamic acid (18F-FSPG). Personalised pharmacokinetic models were constructed based on clinical PET/CT images from five healthy volunteers and blood samples from four of them. Following an identifiability analysis of the developed compartmental models, person-specific model parameters were estimated using the commercial program SAAM II. Organ doses were calculated in accordance to the formalism promulgated by the Committee on Medical Internal Radiation Dose (MIRD) and the International Commission on Radiological Protection (ICRP) using specific absorbed fractions for photons and electrons previously derived for the ICRP reference adult computational voxel phantoms. Organ doses for two concepts were compared: source organ activities in organs parenchyma with blood as a separate source (concept-1); aggregate activities in perfused source organs without blood as a distinct source (concept-2). Aggregate activities comprise the activities of organs parenchyma and the activity in the regional blood volumes (RBV). Concept-1 resulted in notably higher absorbed doses for most organs, especially non-source organs with substantial blood contents, e.g. lungs (92% maximum difference). Consequently, effective doses increased in concept-1 compared to concept-2 by 3-10%. Not considering the blood as a distinct source region leads to an underestimation of the organ absorbed doses and effective doses. The pronounced influence of the blood even for a radiopharmaceutical with a rapid clearance from the blood, such as 18F-FSPG, suggests that blood should be introduced as a separate compartment in most compartmental pharmacokinetic models and blood should be considered as a distinct source in

  3. Radiopharmaceutical projects of CNESTEN (Centre National de l'Energie, des Sciences et des Techniques Nucleaires)

    International Nuclear Information System (INIS)

    2000-01-01

    In nuclear medicine, the prescriptions of isotopic investigations are increasing because they can provide early information about morphological anomalies and permit,so to avoid long and onerous treatments. Until now, Morocco imports the radiopharmaceuticals in spite of the difficulties related to administrative procedures. To facilitate these procedures CNESTEN has launched a project which involves the following activities: - Import and distribution of needed radiopharmaceuticals; - development and production of new radiopharmaceutical kits in cooperation with scientific partners. Priority is given to the most prescribed radiopharmaceuticals. Many kits have been produced with manufacturing protocol modifications aiming to improve and optimize the production processes. The quality of the obtained products is tested and their biodistribution kinetics are studied. (F.M.)

  4. International seminar on therapeutic applications of radiopharmaceuticals. Programme. Book of extended synopses

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-12-01

    The document includes extended synopses of 64 presentations given at the International Seminar on Therapeutic Applications of Radiopharmaceuticals, held in Hyderabad, India, 18-22 January 1999. A separate indexing was prepared for each presentation Refs, figs, tabs

  5. The regional service for the preparation and distribution of radiopharmaceuticals in the west of Scotland

    International Nuclear Information System (INIS)

    Horton, P.W.

    1977-01-01

    The centralised preparation of radiopharmaceuticals was begun in 1965 for reasons of radiological safety and cost effectiveness. It enabled the provision of a single specially designed facility to process large quantities of radioactivity safely and avoided the distributed handling of radioactivity. Effective supervision of the safe usage and disposal of radionuclides in hospitals throughout the region became practicable. It also enabled the bulk purchase of radiopharmaceuticals with lower unit costs and their efficient utilisation due to the large number of users. Since 1965, great changes have taken place in the nature of the common radiopharmaceuticals. Most now have short physical half-lives and must be prepared close to their place of use. This has meant improving the pharmaceutical standards of the facilities and working methods. However, the reasons stated above for a centralised service are still applicable and have been reinforced by others arising from the need for good pharmaceutical manufacturing practice in current radiopharmaceutical production

  6. Quantitative studies in radiopharmaceutical science: Progress report, September 1, 1986 through August 31, 1987

    International Nuclear Information System (INIS)

    Cooper, M.

    1987-09-01

    The reports in the study were processed separately for the data bases. Research involved attempts to improve PET imaging and diagnostic techniques in man. The primary radiopharmaceutical used was a form of fluorodeoxyglucose

  7. International seminar on therapeutic applications of radiopharmaceuticals. Programme. Book of extended synopses

    International Nuclear Information System (INIS)

    1998-12-01

    The document includes extended synopses of 64 presentations given at the International Seminar on Therapeutic Applications of Radiopharmaceuticals, held in Hyderabad, India, 18-22 January 1999. A separate indexing was prepared for each presentation

  8. Development, preparation and control of sup(99m)Tc or sup(113m)In labelled stannous hydroxide radiopharmaceuticals. Part of a coordinated programme on radiopharmaceuticals

    International Nuclear Information System (INIS)

    Alvarez Cervera, J.

    1975-01-01

    The preparation of different sup(99m)Tc and sup(113m)In radiopharmaceuticals using stannous chloride was investigated. Chemical and radiochemical procedures for the quality control of these preparations were studied. Toxicity and biological controls of the preparation were carried out. Procedures for the preparation and control of the following radiopharmaceuticals have been standardized by the authors; albumin macroaggregates labelled with sup(99m)Tc, sup(113m)In and other isotopes for lung scanning; albumin microspheres labelled with sup(99m)Tc for lung scanning; sup(99m)Tc or sup(113m)In-labelled stannous hydroxide colloid for liver scanning; sup(99m)Tc-stannous phytate for liver scanning; sup(99m)Tc-Sn-dextrose, a new radiopharmaceutical which has been proposed by the authors and is now used in Mexico for renal and cerebral scanning and sup(99m)Tc-Sn pyrophosphate and diphosphonate for bone scanning

  9. Approaches to the design of clean air handling facilities for radiopharmaceuticals

    International Nuclear Information System (INIS)

    2000-01-01

    Manufacturing, handling and administering processes of radiopharmaceuticals have to meet the requirements of both the fields viz. ''radio'' activity and ''pharma'' activity. Both these fields often dictate conflicting requirements. A step by step analysis of these conflicts can lead to practices reasonably acceptable to both the fields. The design approaches include engineering concepts of radiation protection, concepts and practices for pharmaceuticals, biologically unsafe products/processes and manufacturing, handling and administering processes of radiopharmaceuticals

  10. Progress on the application of ligand receptor binding assays in radiopharmaceuticals

    International Nuclear Information System (INIS)

    Zhou Xue; Qian Jinping; Kong Aiying; Zhu Lin

    2010-01-01

    Receptor binding assay is an important drug screening method, which can quickly and inexpensively study the interactions between the targeted receptor and the potential ligands in vitro and provide the information of the relative binding affinity of ligand-receptor. The imaging of many radiopharmaceuticals is based on highly selective radioligand-receptor binding. The technique plays an important role in the design and screening of receptor-targeting radiopharmaceuticals. (authors)

  11. Urinary excretion and external radiation dose from patients administered with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Konishi, E.; Abe, K.; Kusama, T.

    1994-01-01

    Patients who have received radiopharmaceuticals become a source of exposure to those near them, such as nursing staff or visiting relatives. In order to provide quantitative information to propose protective measures for carers attending patients administered diagnostic amounts of 99 Tc, 67 Ga or 201 Tl (the most frequently used radiopharmaceuticals) the dose rate at various distances from 84 patients was measured using an ionising chamber, and the radioactivity of these compounds in urine collected from some patients was also measured. (author)

  12. The anesthetics influence (ethilic-eter and urethane) on renal radiopharmaceuticals

    International Nuclear Information System (INIS)

    Muramoto, E.; Achando, S.S.; Araujo, E.B. de; Hamada, H.S.; Silva Valente Goncalves, R. da; Pereira, N.P.S. de; Silva, C.P.G. da.

    1990-01-01

    A comparative study was done using anesthetics like ether ethilic and urethane, in rats (Wistar). A significative variation was observed in the results obtained when renal radiopharmaceuticals were investigated. Using urethane, the renal uptake increase progressivelly due to the inhibition of the renal filtration and it starts to recuperate when the anesthetic effect was eliminated. Using ether ethilic the radiopharmaceuticals are quickly eliminated from the kidneys (tubular or glomerular filtration), showing that the renal function was protected. (author) [pt

  13. Metabolic radiopharmaceutical therapy in nuclear medicine; Terapia metabolica mediante radiofarmacos en medicina nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Reguera, L.; Lozano, M. L.; Alonso, J. C.

    2016-08-01

    In 1986 the National Board of Medical Specialties defined the specialty of nuclear medicine as a medical specialty that uses radioisotopes for prevention, diagnosis, therapy and medical research. Nowadays, treatment with radiopharmaceuticals has reached a major importance within of nuclear medicine. The ability to treat tumors with radiopharmaceutical, Radiation selective therapy has become a first line alternative. In this paper, the current situation of the different therapies that are sued in nuclear medicine, is reviewed. (Author)

  14. Comparison of two methods of radiopharmaceuticals production and evaluation of their quality

    International Nuclear Information System (INIS)

    Portillo L, M.C.; Rodriguez J, S.

    1987-05-01

    Two methods for the following five radiopharmaceuticals production were compared: sulfur colloid, diethylenetriamine pentaacetic calcium salt, phyrophosphate sodium, albumin aggregated, glucoheptonate calcium salt. Radiochemical purity was determined by electrophoresis, thin-layer chromatography and bio-distribution test in mice and rats. It was concluded that chromatographic method shows better efficiency and that bio-distribution test should be done only when testing new radiopharmaceuticals because the good correlation of this test with thin-layer chromatography. (author)

  15. Clinical trials using a radiopharmaceutical investigational drug: What legal environment and what authorizations required?

    International Nuclear Information System (INIS)

    El-Deeb, G.; Nguon, B.; Tibi, A.; Rizzo-Padoin, N.

    2009-01-01

    Recent revision of the legal environment for clinical research in France provided an opportunity to review what a hospital needs to carry out clinical trials using a radiopharmaceutical investigational drug. Legal measures concerning radiopharmaceutical investigational drugs are indeed more complex than those of classical clinical trials because of the additional legal provisions governing the use of ionizing radiation. Thus, requirements by the concerned staff (sponsor, pharmacist, person in charge of the nuclear activity) are described here. (authors) [fr

  16. Calibration and qualification of equipment in the pharmaceutical industry: emphasis on radiopharmaceuticals production

    International Nuclear Information System (INIS)

    Melero, Laura T.U.H.; Silva, Katia S. da S.; Zanette, Camila; Araujo, Elaine B. de; Mengatti, Jair

    2011-01-01

    The calibration and qualification of equipment are listed items in RDC number 17 of 2010 which refers about the Good Manufacturing Practice (GMP) of medicaments and RDC number 63 of 2009 which refers about GMP of Radiopharmaceuticals. Both are essential requirements since they are involved in process control to attend the regulatory criteria and are a key part of the validation process. The aim of this work is presenting the importance of calibration and qualification, and the routine use of equipment and facilities in industrial scale production of radiopharmaceuticals in the IPEN/CNEN. The radiopharmacy of IPEN is a pharmaceutical industry that produces radiopharmaceuticals for diagnosis and therapy. It was the pioneer institute in production of radioisotopes and radiopharmaceuticals in Brazil. Currently, 38 products are distributed to the nuclear medicine centers, including primary radioisotopes, labeled molecules and lyophilized reagents for labeling with technetium-99m. To fulfill the GMP requirements for quality assurance of products, several factors must be considered including infrastructure, equipment and raw materials beyond, obviously, the whole production process should be controlled until the release of the final product. Therefore, the calibration and verification of equipment, instruments and other appliances used in the production and quality control should be performed. A program of calibration, qualification and requalification of equipment used in production and quality control of radiopharmaceuticals is necessary for the validation of production processes and analytical methods, and should be established for quality assurance of produced radiopharmaceuticals. (author)

  17. Calibration and qualification of equipment in the pharmaceutical industry: emphasis on radiopharmaceuticals production

    Energy Technology Data Exchange (ETDEWEB)

    Melero, Laura T.U.H.; Silva, Katia S. da S.; Zanette, Camila; Araujo, Elaine B. de; Mengatti, Jair [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2011-07-01

    The calibration and qualification of equipment are listed items in RDC number 17 of 2010 which refers about the Good Manufacturing Practice (GMP) of medicaments and RDC number 63 of 2009 which refers about GMP of Radiopharmaceuticals. Both are essential requirements since they are involved in process control to attend the regulatory criteria and are a key part of the validation process. The aim of this work is presenting the importance of calibration and qualification, and the routine use of equipment and facilities in industrial scale production of radiopharmaceuticals in the IPEN/CNEN. The radiopharmacy of IPEN is a pharmaceutical industry that produces radiopharmaceuticals for diagnosis and therapy. It was the pioneer institute in production of radioisotopes and radiopharmaceuticals in Brazil. Currently, 38 products are distributed to the nuclear medicine centers, including primary radioisotopes, labeled molecules and lyophilized reagents for labeling with technetium-99m. To fulfill the GMP requirements for quality assurance of products, several factors must be considered including infrastructure, equipment and raw materials beyond, obviously, the whole production process should be controlled until the release of the final product. Therefore, the calibration and verification of equipment, instruments and other appliances used in the production and quality control should be performed. A program of calibration, qualification and requalification of equipment used in production and quality control of radiopharmaceuticals is necessary for the validation of production processes and analytical methods, and should be established for quality assurance of produced radiopharmaceuticals. (author)

  18. Legal aspects of the production and application of radiopharmaceuticals in Germany

    International Nuclear Information System (INIS)

    Kuwert, T.; Prante, O.; Meyer, G.

    2009-01-01

    This article deals with the regulation of the production and use of radiopharmaceuticals in Germany. As in other countries, radiopharmaceuticals may be used when licensed by the German equivalent of the Federal Drug Agency or in clinical trials. Furthermore, non-licensed radiopharmaceuticals can be administered to patients for diagnosis when they are produced in the same institution and not more than 20 doses per week and radiopharmaceutical are given. A prerequisite for these three ways of use is the production of the radiopharmaceutical in question according to the guidelines of the good manufacturing practice (GMP) which creates considerable problems for the usually small PET centers installed in the German university hospitals. German law offers a further possibility to apply non-licensed radiopharmaceuticals for clinical purposes: their administration to patients is not forbidden when performed by a physician who produces the substance himself or is at least responsible for its synthesis. This regulation has, however, been met with criticism by government agencies. (orig.)

  19. HPLC-MS technique for radiopharmaceuticals research and control

    Energy Technology Data Exchange (ETDEWEB)

    Macasek, F; Bruder, P [Department of Nuclear Chemistry, Faculty of Natural Sciences, Comenius University, Bratislava (Slovakia); Buriova, E [Cyclotron Centre of the Slovak Republic, Slovak Office of Standards, Metrology and Testing, Bratislava (Slovakia)

    2002-03-01

    A liquid chromatography/refractive index detector/radiometric detector/ mass spectrometric detector combination (Agilent 1100 HPLC/RAD/DAD/RID/MSD system) is used as a complex technique for quality assessment of radiopharmaceuticals such as 2-deoxy-2-[{sup 18}F]fluoro-D-glucose (FDG). Optimisation of HPLC/MS analysis was performed investigating the electrospray ionisation (ESI) analytical signal of the mass spectrometer as a function of solvent composition. The anion-exchange eluents applied as specified by the pharmacopoeia are not suitable for ESI detection due to high ion concentrations. Therefore, solutions of glucose in methanol/water and acetonitrile/water solutions of various semi-volatile electrolytes (ammonium chloride, formic acid, ammonium formate) were analysed by flow injection analysis (FIA) and chromatographically. The best analytical response was obtained with acetonitrile : 0.25% ammonium formate = 80:20 solutions. The most intense MSD signals of FDG in ammonium formate were obtained for the following complex ions: (i) positive ions: fdg.NH{sub 4}{sup +}, fdg.Na{sup +} and (fdg{sub 2}-CH{sub 3}O).Na{sup +} (m/z = 200, 205 and 344); (ii) negative ions: fdg.Cl{sup -} and fdg.HCOO{sup -} (m/z= 217 and 227). The HPLC-MS analysis with Zorbax C-18 and Asahipak-NH2P50 columns gave evidence of admixtures and radiolytic formation of deoxyglucose, deoxychloro-glucose, erythrose, erythritol, gluconic acid, lactose, raffinose, saccharic acid, sorbitol/[{sup 19}F]FDG, sorbitol/[{sup 19}F]FDG, xylitol, and other compounds. However, radiometric analysis of expired samples of [{sup 18}F]FDG gave evidence of a very high radiation stability of its water-ethanol solutions at the point of output of radioactive products. Remarkable is the exceedingly high complexity of the mass spectra of FDG as compared to glucose. Therefore, further research concerns the influence of sodium chloride, linearity of signal response, impurities (mannitol, mannose etc.) interference, and

  20. HPLC-MS technique for radiopharmaceuticals research and control

    International Nuclear Information System (INIS)

    Macasek, F.; Bruder, P.; Buriova, E.

    2002-01-01

    A liquid chromatography/refractive index detector/radiometric detector/ mass spectrometric detector combination (Agilent 1100 HPLC/RAD/DAD/RID/MSD system) is used as a complex technique for quality assessment of radiopharmaceuticals such as 2-deoxy-2-[ 18 F]fluoro-D-glucose (FDG). Optimisation of HPLC/MS analysis was performed investigating the electrospray ionisation (ESI) analytical signal of the mass spectrometer as a function of solvent composition. The anion-exchange eluents applied as specified by the pharmacopoeia are not suitable for ESI detection due to high ion concentrations. Therefore, solutions of glucose in methanol/water and acetonitrile/water solutions of various semi-volatile electrolytes (ammonium chloride, formic acid, ammonium formate) were analysed by flow injection analysis (FIA) and chromatographically. The best analytical response was obtained with acetonitrile : 0.25% ammonium formate = 80:20 solutions. The most intense MSD signals of FDG in ammonium formate were obtained for the following complex ions: (i) positive ions: fdg.NH 4 + , fdg.Na + and (fdg 2 -CH 3 O).Na + (m/z = 200, 205 and 344); (ii) negative ions: fdg.Cl - and fdg.HCOO - (m/z= 217 and 227). The HPLC-MS analysis with Zorbax C-18 and Asahipak-NH2P50 columns gave evidence of admixtures and radiolytic formation of deoxyglucose, deoxychloro-glucose, erythrose, erythritol, gluconic acid, lactose, raffinose, saccharic acid, sorbitol/[ 19 F]FDG, sorbitol/[ 19 F]FDG, xylitol, and other compounds. However, radiometric analysis of expired samples of [ 18 F]FDG gave evidence of a very high radiation stability of its water-ethanol solutions at the point of output of radioactive products. Remarkable is the exceedingly high complexity of the mass spectra of FDG as compared to glucose. Therefore, further research concerns the influence of sodium chloride, linearity of signal response, impurities (mannitol, mannose etc.) interference, and robustness of the MS analysis, with special attention

  1. Report of the consultants meeting on good manufacturing practices and clean room requirements for radiopharmaceuticals

    International Nuclear Information System (INIS)

    2000-07-01

    Radiopharmaceuticals are compounds containing radioisotopes that are used in nuclear medicine for a variety of diagnostic studies and, to a limited extent, for therapy. Almost 80% of the diagnostic studies are carried out with 99m Tc containing radiopharmaceuticals (half-life, six hours). Recently, another class of radiopharmaceuticals contains the ultra short-lived isotopes 11 C, 13 N and 15 O as well as 18 F, which are mostly produced and immediately used in the hospital cyclotron Positron Emission Tomography (PET) facilities. In therapy, 131 I is widely used for thyroid disorders, 32 P for treatment of abnormal increase in circulating red blood cells, while 153 Sm and 89 Sr are used for palliation of pain in patients suffering from bone metastases. They contain very small amounts of chemical ingredients, normally do not have any pharmacological effects, and are administered in small volumes. Radiopharmaceuticals are produced, used and exported both in developing and developed countries. The scale of production is small compared to conventional pharmaceuticals. Monographs on radiopharmaceuticals can be found in many pharmacopoeias, such as BP, USP, EP and other compendia. This field is also marked by active research and development of new products both for diagnosis and therapy. Traditionally, production and supply of radiopharmaceuticals started as research activities of national nuclear laboratories operating reactors and cyclotrons. Certain products found useful and effective were continued to be provided to the clinics as a service from the nuclear centres. In developed countries demand of radiopharmaceuticals is so considerable that production and sale are increasingly taken over by commercial companies. On the other hand, in many developing countries, demand is still limited, and radiopharmaceutical production and supply still remain more of a service operation at the national nuclear centres. Depending on the radioactivity levels handled, production has to

  2. State of the art and perspectives in radiopharmaceutical field since ACOMEN 8. International Conference (Bordeaux May 11-13, 2005)

    International Nuclear Information System (INIS)

    Vuillez, J.P.; Desruet, M.D.; Desruet, M.D.; Mundler, O.; Karcher, G.

    2009-01-01

    Since previous ACOMEN conference in 2005 on radiopharmaceuticals, many improvements have been encountered: active research has allowed the development of numerous new tracers of interest, with a large part dedicated for PET; clinical applications of radiopharmaceuticals have resulted in patients care improvement, both for management and survival; therapeutic applications are now fully recognized, as internal targeted radiotherapy could be considered as efficient in several cancer diseases; and regulation, despite remaining difficulties, will certainly become more favourable for radiopharmaceuticals. Thus we could make sure that radiopharmaceuticals use will be even more established in the next years. (authors)

  3. Nuclear medicine and imaging research (quantitative studies in radiopharmaceutical science). Progress report, January 1, 1984-December 31, 1984

    International Nuclear Information System (INIS)

    Beck, R.N.; Cooper, M.D.

    1984-09-01

    This report presents progress in the areas of cardiac nuclear medicine, other imaging studies, investigations with biomolecules, and assessment of risks associated with the clinical use of radiopharmaceuticals

  4. Determination of tin (II) in radiopharmaceutical kits by polarographic method

    International Nuclear Information System (INIS)

    Aungurarat, A.; Thuntawewadthananon, T.

    1996-01-01

    Radiopharmaceutical kit is a diagnostic compound which contains Stannous (II) as a reducing agent. The quantity of Stannous (II) is depended on the type of kits. So the quantity of Stannous (II) is determined by polarographic method with Differential Pulse Voltammetry (D P Mode) in which a saturated calomel electrode is used as anode and a dropping mercury electrode is used as cathode. Both of electrodes are immerged in the premixed solution of supporting electrolyte and analytical Stannous (II). The Stannous (II) is determined by direct method Stannous (II) is analyzed in the form of Stannous; Sn 2 + itself, and indirect method Stannous (II) is analyzed in the form of S tannic; Sn 4+ (Sn 2+ , + N H 4 + ----> Sn 4+ ). Both methods are done at polarographic half wave potential -470 and -520 mV respectively. The Limit of Detection (LOD) of the direct method is 1.9445 micro g and indirect method is 1.3018 micro g. The result received from indirect method is much more accurate than the direct method (Sn 2+ ). The accuracy of the direct method is about 97.5-102.5% recovery

  5. Concentration of 188Re-Perrhenate for Therapeutic Radiopharmaceuticals

    International Nuclear Information System (INIS)

    Bokhari, T.H.; Hina, S.; Ahmad, M.; Iqbal, M.

    2013-01-01

    Summary: Rhenium-188 (T1/2=16.9h) has great potential for a variety of therapeutic applications, including radionuclide synovectomy, oncology and bone pain palliation. The radioactive concentration of 188Re is dependent upon the specific activity of 188W, which dictates the bed size of the alumina/gel column. Due to the high content of inactive tungsten in neutron irradiated WO3, large columns containing aluminum oxide or gel are needed to prepare to double neutron capture based 188W/188Re generators that results in large elution volumes containing relatively high188W contents and low concentrations of /sup 188/ ReO/sub 4/ This decrease in specific volume of 188ReO/sub 4/ places a limitation because a high radioactive concentration of 188ReO4 - is always needed for filling angioplasty balloons or other therapeutic radiopharmaceuticals like188Re -EHDP 188Re -EDTMP, 188Re - MAG3 and 188Re -DTPA. We report post elution concentration of 188ReO4 - using in- house prepared lead cation exchange and alumina columns. Using these columns high bolus volume (10 mL saline) of 188ReO4 - can conveniently be concentrated in 1 mL of physiological saline for therapeutic use. (author)

  6. Some radiopharmaceuticals derived from carbon-eleven labelled phosgene

    International Nuclear Information System (INIS)

    Roeda, D.

    1982-01-01

    This thesis deals with some applications of the short lived cyclotron produced radioisotope carbon-11 (half life 20.4 min.) For medical use. Both chemical manipulation of highly radioactive gamma emitting material in order to prepare suitable 11 C-labelled radiopharmaceuticals and two clinical studies are discussed. The first chapter comprises a general introduction concerning the application of the ''tracer principle'' to the short lived positron emitting radionuclides 18 F, 11 C, 13 N and 15 O in medicine. Chapter two deals with the synthesis of 11 COCl 2 . This product is a useful new 11 C-synthon with many potential applications. In chapter three the synthesis of 11 C-urea from 11 C-phosgene for medical use is described. The method uses the reaction of 11 COCl 2 with aqueous ammonia. Chapter four deals with the synthesis of 11 C-barbituric acids and 11 C-hydantoins and presents a clinical study on epilepsy, using 2- 11 C-5,5-diphenylhydantoin ( 11 C-DPH). Patients having intractable epilepsy and patients having no epilepsy were given intravenously a single dose of 11 C-DPH after which the accumulation of the radioactivity in the brain was followed by positron emission tomography. No regional concentration differences could be found near epileptic foci. There was a faint indication that there are some differences in uptake for whole brain between the two categories of patients. (Auth.)

  7. Uptake of SPECT radiopharmaceuticals in neocortical brain cultures

    Energy Technology Data Exchange (ETDEWEB)

    Jong, B.M. de; Royen, E.A. van

    1989-01-01

    The uptake, retention and uptake antagonism of /sup 201/Tl-DDC, /sup 201/Tl-Cl, /sup 123/I-IMP, /sup 99m/Tc-HMPAO and /sup 99m/Tc-O4/sup -/ were compared in rat neocortex cultures. /sup 201/Tl-DDC and /sup 123/I-IP revealed the highest uptake of radioactivity in the cultures. /sup 99m/Tc-HMPAO and /sup 123/I-IMP showed the highest retention of radioactivity within the tissue in washout experiments. Blocking of bioelectric activity by tetrodotoxin did not significantly affect the uptake of the radiopharmaceuticals (RPHA). Inhibition of Na K ATPase by ouabain inhibited the uptake of /sup 201/Tl-Cl (77%) and /sup 201/Tl-DDC (27%). Imipramine showed a significantly stronger inhibitory effect on /sup 123/I-IMP uptake in comparison with the effect on other RPHA. /sup 99m/Tc-O4/sup -/ was not concentrated within the cultured tissue. Under the in vitro conditions used in this study, the various RPHA were characterised by distinct differences in their interaction with cortical brain tissue.

  8. Radiopharmaceuticals based on the scandium or rhodium radionuclides

    International Nuclear Information System (INIS)

    Majkowska, A.; Pruszynski, M.; Bilewicz, A.

    2006-01-01

    Radionuclides 103m Rh, 105 Rh emitting β-radiation or 47 Sc (Auger electrons emitter) are suitable for treatment small tumors spread over the human tissues. Presented communication describes preliminary results obtained in the Institute of Nuclear Chemistry and Technology, Warsaw (Poland) in the field of obtaining new complexes containing the aforementioned radionuclides. The radionuclides can be produced in the laboratory scale from simple and cheap generators. 103m Rh and 105 Rh cations were complexed with the thioetheric ligand (1,5,9,13-tetrathiacyclahexadecane-3,11-diole) and in the future, after funcionalization with certain biomolecules, are promising radiopharmaceuticals. 47 Sc cation was complexes by one from the following tri- or tetraaza macoryclic ligands: 1,4,7,10-triazacyclononane-1,4,7-triacetic acid (NOTA), 1,4,7,10-tetraazacyclododecane-1,7-diacetic acid (DO2A) or 1,4,7,10-triazacyclononane-1,4,7-triacetic acid (NOTA), 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA). Composition and the stability constants of the complexes were determined

  9. FDA's requirements for radiation dosimetry of radiopharmaceutical drug products

    International Nuclear Information System (INIS)

    Abel, N.M.

    1986-01-01

    The primary concern of the Office of Drug Research and Review of the Food and Drug Administration in the field of radiation dosimetry is to ensure that radiopharmaceutical drug products are safe when used as investigational drugs (INDs) and are both safe and effective when a new drug application (NDA) is approved. In order to accomplish this, the sponsor of either an IND or applicant in the case of NDA must provide information that clearly describes the radiation dose that a patient will receive from the administration of the drug. The submitted numerical estimates of the radiation dose should be based on an absorbed fraction method of radiation dose calculation, such as the system set forth by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine or the system set forth by the International Commission on Radiological Protection (ICRP). This presentation will describe in detail the data that a sponsor of an IND needs to submit to satisfy the regulatory requirements. Examples will be given of common mistakes and omissions by sponsors in their presentation of data

  10. AUTOMATION FOR THE SYNTHESIS AND APPLICATION OF PET RADIOPHARMACEUTICALS

    International Nuclear Information System (INIS)

    Alexoff, D.L.

    2001-01-01

    The development of automated systems supporting the production and application of PET radiopharmaceuticals has been an important focus of researchers since the first successes of using carbon-11 (Comar et al., 1979) and fluorine-18 (Reivich et al., 1979) labeled compounds to visualize functional activity of the human brain. These initial successes of imaging the human brain soon led to applications in the human heart (Schelbert et al., 1980), and quickly radiochemists began to see the importance of automation to support PET studies in humans (Lambrecht, 1982; Langstrom et al., 1983). Driven by the necessity of controlling processes emanating high fluxes of 511 KeV photons, and by the tedium of repetitive syntheses for carrying out these human PET investigations, academic and government scientists have designed, developed and tested many useful and novel automated systems in the past twenty years. These systems, originally designed primarily by radiochemists, not only carry out effectively the tasks they were designed for, but also demonstrate significant engineering innovation in the field of laboratory automation

  11. Investigation on chemistry of model compounds of technetium radiopharmaceuticals

    International Nuclear Information System (INIS)

    Muenze, R.; Hartmann, E.

    1983-01-01

    The report summarized experimental and theoretical results concerning the chemical structures and the biodistribution of hydrophilic technetium chelates with hydroxycarboxylic and aminopolycarboxylic acids, thiol compounds and aliphatic and aromatic nitrogen compounds as ligands. Methods which are suitable for synthesizing and characterizing defined chelates of Tc(V), Tc(IV) and Tc(III) have been developed for crystlline substances and species in solution, respectively. For certain types of technetium chelates three dimensional structure models were calculated from atomic parameters. The electron energies and electron distribution of Tc(V) thiol compounds were calculated by quantum chemical methods in order to interprete physical properties of these substances. Biodistribution studies revealed relationships between the osteotropic behaviour and the structure of phosphorous and non-phosphorous technetium chelates and between the kidney uptake and ligand exchange ability of Tc(V) hydroxycarboxylates. Important parameters for the production of technetium-99m kits have been elaborated and used for the optimization of radiopharmaceuticals (bone-, kidney and hepatobiliaer agents). (author)

  12. New SPECT and PET Radiopharmaceuticals for Imaging Cardiovascular Disease

    Directory of Open Access Journals (Sweden)

    Oyebola O. Sogbein

    2014-01-01

    Full Text Available Nuclear cardiology has experienced exponential growth within the past four decades with converging capacity to diagnose and influence management of a variety of cardiovascular diseases. Single photon emission computed tomography (SPECT myocardial perfusion imaging (MPI with technetium-99m radiotracers or thallium-201 has dominated the field; however new hardware and software designs that optimize image quality with reduced radiation exposure are fuelling a resurgence of interest at the preclinical and clinical levels to expand beyond MPI. Other imaging modalities including positron emission tomography (PET and magnetic resonance imaging (MRI continue to emerge as powerful players with an expanded capacity to diagnose a variety of cardiac conditions. At the forefront of this resurgence is the development of novel target vectors based on an enhanced understanding of the underlying pathophysiological process in the subcellular domain. Molecular imaging with novel radiopharmaceuticals engineered to target a specific subcellular process has the capacity to improve diagnostic accuracy and deliver enhanced prognostic information to alter management. This paper, while not comprehensive, will review the recent advancements in radiotracer development for SPECT and PET MPI, autonomic dysfunction, apoptosis, atherosclerotic plaques, metabolism, and viability. The relevant radiochemistry and preclinical and clinical development in addition to molecular imaging with emerging modalities such as cardiac MRI and PET-MR will be discussed.

  13. The centralised production and quality control of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Boyd, R.E.

    1980-01-01

    The concept of a centralised facility for the production testing and distribution within a metropolitan, regional or national area, although not new, is now gaining widespread acceptance in many countries. The rationalisation of resources and operation on a large scale ensures savings in costs. The aim of the centralised radiopharmacy is the regular and routine provision of high quality radiopharmaceuticals and to do this it must have access to a multidisciplinary group of scientists working with the support of trained technicians. These specialists require working facilities which are quite unique and designed according to complex engineering criteria to ensure the safety both of the environment and the patient. Production processes and equipment must be selected on the basis of reliability, minimal operational skill and the ease of maintenance. The infra structure of the organisation must provide the logistic support to ensure that the products from the centralized radiopharmacy reach the end-users at the times, places and in the amounts requested. This should be achieved with a success rate which engenders confidence. The Australian Atomic Energy Commission has operated a national radiopharmacy for more than a decade, delivering more than 150000 patient doses per year over the vast distances which separate the Australian capital cities. These activities have helped nuclear medicine to flourish in Australia; it is expected that the creation of the radioisotope production facilities at PUSPATI will have the same effect in Malaysia. (author)

  14. Characterization of electrochemically and chemically generated technetium diphosphonate radiopharmaceuticals

    International Nuclear Information System (INIS)

    Martin, J.L. Jr.

    1987-01-01

    Tc-Methylene diphosphonate, (MDP), the skeletal imaging ligand is most use in radiopharmacies, is the first metal-ligand complex prepared electrochemically in this work. A similar systematic evaluation of electrochemically reduced Tc-dimethylaminomethylene diphosphonate (DMAD) is presented. DMAD as well as MDP have been characterized by anion exchange HPLC following NaBH4 reduction. The goal is twofold. First, the effect of varying the applied potential on the resultant chromatographic distribution of complexes is investigated. Secondly, the combination(s) of applied potential and preparation pH which preferentially directs the formation of technetium diphosphonate complexes previously shown to be superior skeletal imaging agents is determined. EXAFS, extended x-ray absorption fine structure spectroscopy, is applied to the analysis of dilute solutions (10mM) of electrochemically and chemically reduced Tc-MDP complexes. Further characterizations of electrochemically and chemically generated complexes are performed using in-vitro and in-vivo physiological techniques of biodistribution and blood clearance studies on Sprague Dawley rats and beagle dogs respectively. Finally, in-vitro and in-vivo dilution studies were performed using water, human and dog urine, to determine the influence of the physiological environment on clinically prepared and injected radiopharmaceuticals

  15. Molecular modeling in the development of metal radiopharmaceuticals

    International Nuclear Information System (INIS)

    Green, M.A.

    1993-10-01

    We began this project with a compilation of a structural library to serve as a data base containing descriptions of the molecular features of metal-labeled radiopharmaceuticals known to efficiently cross the blood-brain barrier. Such a data base is needed in order to identify structural features (size, shape, molecular surface areas and volumes) that are critical in allowing blood-brain barrier penetration. Nine metal complexes have been added to this structural library. We have completed a detailed comparison of four molecular mechanics computer programs QUANTA, SYBYL, BOYD, and MM2DREW to assess their applicability to modeling the structures of low molecular weight metal complexes. We tested the ability of each program to reproduce the crystallographic structures of 38 complexes between nickel(II) and saturated N-donor ligands. The programs were evaluated in terns of their ability to reproduce structural features such as bond lengths, bond angles, and torsion angles. Recently, we investigated the synthesis and characterization of lipophilic cationic gallium complexes with hexadentate bis(salicylaldimine) ligands. This work identified the first gallium-68 radiopharrnaceuticals that can be injected intravenously and that subsequently exhibit significant myocardial uptake followed by prolonged myocardial retention of 68 Ga radioactivity. Tracers of this type remain under investigation as agents for evaluation of myocardial perfusion with positron emission tomography

  16. Drugs that alter biodistribution and kinetics of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Shani, J.

    1986-01-01

    Target localization and organ biodistribution of radiopharmaceuticals (RPs) may be altered by non-radioactive drugs whose pharmacological mechanisms compete with the RPs for the same retention processes. Originally referred to as side effects or incompatibilities, such interactions became a major concern in evaluating Nuclear Medicine procedures, as they might cause interpretation of the latter to be without value or misleading. With accumulated experience, some interactions were intentionally included in Nuclear Medicine procedures and became an additional tool in differential diagnosis. Moreover, due to the ability of some RPs to compete with therapeutic agents, Nuclear Medicine studies shifted from anatomical-physiological to more pharmacologically-pathologically-based procedures that can also monitor the stage of disease, and follow its treatment. The aim of this review, therefore, is not only to illustrate some crucial pharmacological issues in Nuclear Medicine imaging, but to emphasize the possible input that alterations of RP biodistribution by drugs may have in achieving better and safer diagnosis, disease staging and monitoring of the patient's response to therapy. 166 references

  17. Radiopharmaceutical activities administered for paediatric nuclear medicine procedures in Australia

    International Nuclear Information System (INIS)

    Towson, J.E.; Smart, R.C.; Rossleigh, M.A.

    2001-01-01

    A survey of radiopharmaceutical activities used at the eight hospital centres specialising in paediatric nuclear medicine in Australia was conducted in 1999-2000 by the Australian and New Zealand Society of Nuclear Medicine and the Australasian Radiation Protection Society. Data on the maximum and minimum administered activities (A max and A min ) as obtained for 43 paediatric imaging procedures are presented. The results are also available on the ANZSNM and ARPS websites at: http://www.anzsnm.org.au and http://www.arps.org.au. The A max values were significantly less than the corresponding Reference Activities for adults determined in a previous study. Activities for individual patients are calculated using surface area scaling at five centres and body weight scaling at three centres. The median values of A max and A min are recommended as Paediatric Reference Activities. The effective dose to patients of various sizes for the Paediatric Reference Activities and both methods of scaling was calculated for each procedure. Copyright (2000) The Australian and New Zealand Society of Nuclear Medicine Inc

  18. Intelligent portal monitor for fast suppression of false positives due to radiopharmaceuticals

    International Nuclear Information System (INIS)

    Johnson, M.W.; Butterfield, K.B.

    1985-01-01

    Monitoring the movement of radioactive material through secure or sensitive areas may be complicated by the existence of unanticipated sources of radiation carried by individuals passing through the area. Typical of such sources are radiopharmaceuticals prescribed for a medical procedure. We report here on an apparatus designed to quickly discriminate between in-vivo radiopharmaceuticals and other nuclear materials, based on a pattern-recognition algorithm and a microcomputer. Principles of operation are discussed, and the data base for the pattern-recognition algorithm is displayed. Operating experience with the apparatus in a trial location is also discussed. Our apparatus correctly identifies in-vivo radiopharmaceuticals in over 80% of all trials; challenges with radioisotopes other than radiopharmaceuticals have led the apparatus, without exception, to reject the challenge isotope as incompatible with medical practice. The apparatus thus rapidly discriminates between individuals bearing radiopharmaceuticals and those bearing illicit sources, such as special nuclear materials. Examples of applications are presented. 7 refs., 4 figs., 1 tab

  19. Determination of radiochemistry purity and pH of radiopharmaceutical in Northeast nuclear medicine services

    International Nuclear Information System (INIS)

    Andrade, Wellington; Santos, Poliane; Lima, Fernando de Andrade; Lima, Fabiana Farias de

    2013-01-01

    The radiopharmaceutical is a chemical compound associated with a radionuclide, which is selected so that meets the need cf diagnosis and capable of producing quality images. Drugs labeled with 99m Tc radionuclide kits consist of lyophilized, and be handled by the nuclear medicine services (NMS) must pass tests as the resolution of ANVISA (RDC 38) published in 2008. Among these tests are those of radiochemical purity and pH determination. This study evaluated the radiochemical purity of radiopharmaceuticals and pH SMN manipulated in the Northeast. The radiochemical purity (RCP) was determined by thin layer chromatography, which were used Whatman ® and silica gel, with dimensions of 1 x 10 cm, as stationary phase, and solvents indicated in the inserts of manufacturers. The chromatographic strips were placed in sealed containers so as not to touch the walls thereof. After the chromatographic run, the tape was cut every centimeter and the activities determined in doses of each calibrator NMS. The pH of the radiopharmaceutical was assessed through the use of universal pH paper (Merck®) and obtained staining compared with its color scale. The results showed (hat 82.6% and 100% of the radiopharmaceuticals of the samples were within the limits recommended by international pharmacopoeias for radiochemical purity and pl-l, respectively. There is then the need to include in routine tests indicated SMN by ANVISA. Well, they can detect possible problems in the marking of radiopharmaceuticals administered to the patient and avoid inappropriate material. (author)

  20. Untangling the web of European regulations for the preparation of unlicensed radiopharmaceuticals : a concise overview and practical guidance for a risk-based approach

    NARCIS (Netherlands)

    Lange, Rogier; ter Heine, Rob; Decristoforo, Clemens; Penuelas, Ivan; Elsinga, Philip H.; van der Westerlaken, Monique M. L.; Hendrikse, N. Harry

    Radiopharmaceuticals are highly regulated, because they are controlled both as regular medicinal products and as radioactive substances. This can pose a hurdle for their development and clinical use. Radiopharmaceuticals are fundamentally different from other medicinal products and these regulations

  1. Potential radiopharmaceuticals for the detection of ocular melanoma. Pt. 3

    International Nuclear Information System (INIS)

    Langevelde, A. van; Molen, H.D. van der; Journee-de Korver, J.G.; Paans, A.M.J.; Pauwels, E.K.J.; Vaalburg, W.; Rijksuniversiteit Leiden

    1988-01-01

    In order to investigate the possibility of using [1- 11 C] labelled 3,4-dihydroxyphenylalanine (DOPA) and tyrosine as radiopharmaceuticals for the detection of eye melanoma, the biodistributions of the same 1- and 3- 14 C-labelled compounds were investigated in Syrian golden hamsters with Greene melanoma. The results of these investigations were compared with positron emission tomography (PET) images of 11 C labelled DOPA and tyrosine. The synthesis of these 11 C labelled compounds procures of DL mixture, from which D and L forms can be separated. One h after intravenous injection, both 14 C labelled DL-, L- and D-DOPA showed a high uptake in tumour tissue, that of DL- and D-DOPA being the highest. These high uptakes, together with relatively low uptake in bone, skin and eye resulted in high tumour/non tumour ratio (for DL-DOPA 5.9, 4.5 and 6.6 respectively). Extraction of the tumour tissue with trichloroacetic acid showed that L-DOPA was mainly incorporated into melanin, whereas D-DOPA was not. Also, the uptake 1 h after intravenous injection of 1- 14 C-L- and DL-tyrosine into the tumour were high, but L- and DL- were less different; tumour/non tomour ratios were favorable. PET images of the tumour obtained 40-80 min after injection of the [1- 11 C] labelled DOPA and tyrosine confirmed that melanoma detection was promising and that D-DOPA produced a better melanoma image than L-DOPA. (orig.)

  2. Quality control of radiopharmaceutical dose calibrators in nuclear medicine unit

    International Nuclear Information System (INIS)

    Oliveira, C.F.M.; Lucindo Junior, C.R.; Lopes Filho, F.J.

    2015-01-01

    As part of the program to ensure quality in nuclear medicine unit, in addition to diagnostic procedures, are evaluated activity meters, which is intended to measure the aliquot of radiation of radionuclides and / or radiopharmaceuticals that are administered to patients undergoing diagnostic investigation and / or therapeutic treatment. The good operating condition of dose calibrators is essential to ensure efficiency, safety and reliability of the measurements, once the lack of accuracy in the responses of these equipments can cause significant errors in the activity administered to the patient and may result in poor quality images resulting in the repetition of examis and interference in the successful treatment of the patient. This study aims to, considering the need for constant evaluation of the functioning of the activity meters and the fact that this issue be part the responsibilities of the professional of radiology, perform quality control testing of these instruments in relation to the most recent norm of National Commission of nuclear Energy (CNEN-NN 3:05) in Brazil, that is also in according to the international standards and reference values established during acceptance testing of these instruments in a nuclear medicine service. For this, was made a review of specific literature and the use of barium, cobalt and cesium to the tests in a nuclear medicine service of the state of Pernambuco in Brazil. The obtained results of the specific tests utilized to verify the correct working of the dose calibrators show coherency with the resolutions of the CNEN-NN 3:05 and are also in agreement with the international standards to that the measurement of activities be made with accurate results and thereby contribute to the proper functioning of nuclear medicine service. (authors)

  3. Lutetium-177 DOTATATE Production with an Automated Radiopharmaceutical Synthesis System.

    Science.gov (United States)

    Aslani, Alireza; Snowdon, Graeme M; Bailey, Dale L; Schembri, Geoffrey P; Bailey, Elizabeth A; Pavlakis, Nick; Roach, Paul J

    2015-01-01

    Peptide Receptor Radionuclide Therapy (PRRT) with yttrium-90 ((90)Y) and lutetium-177 ((177)Lu)-labelled SST analogues are now therapy option for patients who have failed to respond to conventional medical therapy. In-house production with automated PRRT synthesis systems have clear advantages over manual methods resulting in increasing use in hospital-based radiopharmacies. We report on our one year experience with an automated radiopharmaceutical synthesis system. All syntheses were carried out using the Eckert & Ziegler Eurotope's Modular-Lab Pharm Tracer® automated synthesis system. All materials and methods used were followed as instructed by the manufacturer of the system (Eckert & Ziegler Eurotope, Berlin, Germany). Sterile, GMP-certified, no-carrier added (NCA) (177)Lu was used with GMP-certified peptide. An audit trail was also produced and saved by the system. The quality of the final product was assessed after each synthesis by ITLC-SG and HPLC methods. A total of 17 [(177)Lu]-DOTATATE syntheses were performed between August 2013 and December 2014. The amount of radioactive [(177)Lu]-DOTATATE produced by each synthesis varied between 10-40 GBq and was dependant on the number of patients being treated on a given day. Thirteen individuals received a total of 37 individual treatment administrations in this period. There were no issues and failures with the system or the synthesis cassettes. The average radiochemical purity as determined by ITLC was above 99% (99.8 ± 0.05%) and the average radiochemical purity as determined by HPLC technique was above 97% (97.3 ± 1.5%) for this period. The automated synthesis of [(177)Lu]-DOTATATE using Eckert & Ziegler Eurotope's Modular-Lab Pharm Tracer® system is a robust, convenient and high yield approach to the radiolabelling of DOTATATE peptide benefiting from the use of NCA (177)Lu and almost negligible radiation exposure of the operators.

  4. Aptamer-based radiopharmaceuticals for diagnostic imaging and targeted radiotherapy of epithelial tumors

    International Nuclear Information System (INIS)

    Missailidis, Sotiris; Perkins, Alan; Santos-Filho, Sebastiao David; Fonseca, Adenilson de Souza da; Bernardo-Filho, Mario

    2008-01-01

    In the continuous search for earlier diagnosis and improved therapeutic modalities against cancer, based on our constantly increasing knowledge of cancer biology, aptamers hold the promise to expand on current antibody success, but overcoming some of the problems faced with antibodies as therapeutic or delivery agents in cancer. However, as the first aptamer reached the market as an inhibitor against angiogenesis for the treatment of macular degeneration, aptamers have found only limited applications or interest in oncology, and even less as radiopharmaceuticals for diagnostic imaging and targeted radiotherapy of tumours. Yet, the chemistry for the labelling of aptamers and the options to alter their pharmacokinetic properties, to make them suitable for use as radiopharmaceuticals is now available and recent advances in their development can demonstrate that these molecules would make them ideal delivery vehicles for the development of targeted radiopharmaceuticals that could deliver their radiation load with accuracy to the tumour site, offering improved therapeutic properties and reduced side effects. (author)

  5. Experience in the quality control of commercial and self-labelled radiopharmaceuticals

    International Nuclear Information System (INIS)

    Strehlau, E.; Weiland, J.

    1980-01-01

    Different methods of quality control of radiopharmaceuticals checked in the laboratory practice are summarized. Starting from the general organization of quality control in the clinical radiochemical laboratory methods of analysis and working regulations are discussed. The quality tests of sup(99m)Tc-generator eluate, that is the testing for radioactive contaminants and for soluble aluminium as well as the testing of sup(99m)Tc-labelled kits and of different other frequently used radiopharmaceuticals are described in detail. Special conditions of examination and results of chromatography and medium-voltage electrophoresis are also given. Furthermore the routine determination of the output in the labelling of denaturated erythrocytes with sup(99m)Tc is discussed. The clinical practice in the case of preparation deficiencies and of possible incidents following the application of radiopharmaceuticals is outlined. (author)

  6. Indirect iodometric procedure for quantitation of Sn(II) in radiopharmaceutical kits

    International Nuclear Information System (INIS)

    Muddukrishna, S.N.; Chen, A.; Sykes, T.R.; Noujaim, A.A.; Alberta Univ., Edmonton, AB

    1994-01-01

    A method of quantitating stannous ion [Sn(II)] suitable for radiopharmaceutical kits, based on indirect iodometric titration, is described. The method is based on the oxidation of Sn(II) using a known excess of iodine and the excess unreacted iodine determined using thiosulphate by potentiometric titration. The titration cell is a beaker and the titrations are done conveniently under air using an autotitrator in approx. 4 min. The method is accurate and is linear in the range of approx. 10 μg to approx. 6 mg of Sn(II). Several radiopharmaceutical kits were analysed for their Sn(II) content using the method including those containing antibodies or other proteins. The studies indicate that the procedure is rapid, simple and accurate for routine quantitative estimation of Sn(II) in radiopharmaceutical preparations during development, manufacture and storage. (Author)

  7. Aptamer-based radiopharmaceuticals for diagnostic imaging and targeted radiotherapy of epithelial tumors

    Energy Technology Data Exchange (ETDEWEB)

    Missailidis, Sotiris [The Open University, Milton Keynes (United Kingdom). Dept. of Chemistry and Analytical Sciences]. E-mail: s.missailidis@open.ac.uk; Perkins, Alan [University of Nottingham (United Kingdom). Dept. of Medical Physics; Santos-Filho, Sebastiao David; Fonseca, Adenilson de Souza da; Bernardo-Filho, Mario [Universidade do Estado do Rio de Janeiro (UERJ), RJ (Brazil). Inst. de Biologia Roberto Alcantara Gomes. Dept. de Biofisica e Biometria

    2008-12-15

    In the continuous search for earlier diagnosis and improved therapeutic modalities against cancer, based on our constantly increasing knowledge of cancer biology, aptamers hold the promise to expand on current antibody success, but overcoming some of the problems faced with antibodies as therapeutic or delivery agents in cancer. However, as the first aptamer reached the market as an inhibitor against angiogenesis for the treatment of macular degeneration, aptamers have found only limited applications or interest in oncology, and even less as radiopharmaceuticals for diagnostic imaging and targeted radiotherapy of tumours. Yet, the chemistry for the labelling of aptamers and the options to alter their pharmacokinetic properties, to make them suitable for use as radiopharmaceuticals is now available and recent advances in their development can demonstrate that these molecules would make them ideal delivery vehicles for the development of targeted radiopharmaceuticals that could deliver their radiation load with accuracy to the tumour site, offering improved therapeutic properties and reduced side effects. (author)

  8. Determination of the influence factors of the radiopharmaceutical vials dimensions used for activimeter calibration at IPEN

    International Nuclear Information System (INIS)

    Martins, E.W.; Potiens, M.P.A.

    2012-01-01

    This paper presents the establishment of a quality control program and correction factors for the geometry of the vials used for distribution of radiopharmaceutical and activimeters calibration. The radiopharmaceutical produced by IPEN 67 Ga, 131 I, 201 Tl and 99m Tc had been tested using two different vials. Results show a maximum variation of 22% for 201 Tl, and the minimum variation was 2.98% for 131 I. The correction factors must be incorporated in the routine calibration of the activimeters. - Highlights: ► Establishement of quality control program for reference activimeters. ► Determination of correction factors for the geometry of vials. ► Radiopharmaceuticals tested for different vials were 67 Ga, 131 I, 201 Tl and 99m Tc. ► The maximum variation was 22% for 201 Tl and the minimum variation was 2.98% for 131 I. ► Correction factors must be incorporated in the calibration of the activimeters.

  9. Production of PET radiopharmaceutical 18F-FDG using synthesizer automatic module

    International Nuclear Information System (INIS)

    Purwoko; Chairuman; Adang Hardi Gunawan; Yayan Tahyan; Eny Lestari; Sri Aguswarini Lestiyowati; Karyadi; Sri Bagiawati

    2010-01-01

    Radiopharmaceutical 2-( 18 F)Fluoro-2-Deoxy-D-Glucose or 18 F(FDG) is an important PET (Positron Emission Tomography) radiopharmaceutical for tumour imaging. In the PET technique glucose metabolism in tumour tissues can be determined quantitatively and used for diagnosis staging and monitoring of treatment tumour or cancer disease in medical oncology. The production of 2-( 18 F)Fluoro-2-Deoxy-D-Glucose 18 F-FDG using compact automated system module TRACERlab MX has been carried out. The modular setup of the apparatus permits reliable for routine synthesis of radiopharmaceuticals 18 F-FDG based on kriptofix mediated nucleophilic fluorination to mannose triflate precursor. Radiochemical yield of 18 F-FDG was 53.895 % (decay time uncorrected) in 40 minutes. The product showed that the colorless and clear solution at pH:6, sterile and pirogen free, kriptofix impurities was low and radiochemical purity was 99.595%. (author)

  10. Characterization of contaminated nuclear sites, facilities and materials: radioisotope and radiopharmaceutical manufacturers and suppliers. Final report

    International Nuclear Information System (INIS)

    1983-01-01

    The Environmental Protection Agency (EPA) is developing environmental protection standards for evaluating the risks and characterizing problems associated with disposal of radioactive wastes arising from decontamination and decommissioning DandD operations. Information on operations conducted at sites authorized to possess radioactive materials for the production and/or distribution of radioisotopes and radiopharmaceuticals was compiled and evaluated. This information was used to project the types, nature, and volumes of wastes which are likely to be generated during decontamination and decommissioning at representative facilities and identifying special problems that may occur. Radioisotope and radiopharmaceutical manufacturers have been grouped together because decommissioning operations will be similar. Nuclear pharmacies were also evaluated because of their increasing numbers and their role as middlemen between manufacturers and users of radiopharmaceuticals. The majority of the radioactive waste will arise from the decontamination of the laboratories, rather than the disposal of components

  11. Quality evaluation of radiopharmaceuticals in nuclear medicine services in the states of Alagoas and Sergipe - Brazil

    International Nuclear Information System (INIS)

    Santos, Poliane Angelo de Lucena; Andrade, Wellington Gomes de; Lima, Fernando Roberto de Andrade; Lima, Fabiana Farias de

    2011-01-01

    Radiopharmaceuticals are compounds associated with a radionuclide. They can be considered as vectors that have some specificity for an organ or a physiological or pathophysiological function. Assessing the radiopharmaceutical's quality is essential to obtain adequate images, avoiding repetition of examinations and unnecessary absorbed dose to the patient. Resolution no. 8 (RCD 38) of 06/04/2008 by Agencia Nacional de Vigilancia Sanitaria (ANVISA) states the obligation of performing a minimum of tests in the routines of nuclear medicine services (NMS). The aim of this work was to evaluate the radiochemical purity and pH of radiopharmaceuticals used in NMS in states of Alagoas and Sergipe - Brazil. Radiochemical purity was determined by thin layer chromatography where a paper Whatman and TLC were used as steady state and the solvents were used related to the appropriate radiopharmaceutical, both as recommended by the manufacturer's directions. The chromatographic strips were placed in closed containers to avoid contact with the walls. After, the strips were cut in 1cm pieces and the activity was determined in each NMS's activity calibrators. The radiopharmaceuticals pH was evaluated by using universal pH paper (Merck) and the obtained color was compared with its range of colors. It was observed that 33.34% and 2.3% of the tested radiopharmaceuticals showed PRQ (radiochemical purity) and pH values, respectively, are outside of the limits described by the manufacturers. The results show that the radiochemical purity assessment in the NMS's routine can indicate problems with a radioisotope tagging, allowing their exclusion before administration. (author)

  12. Implementation of the Good Practices of Manufacture of PET Radiopharmaceuticals in INOR

    International Nuclear Information System (INIS)

    Sinconegui Gómez, Belkys; Quesada Cepero, Waldo; González González, Joaquín J.; Calderón Marín, Carlos F.; Varela Corona, Consuelo; Figueroa, Roberto

    2016-01-01

    The growing advance of new technologies in Nuclear Medicine such as positron emission tomography (PET) allows visualizing biological processes in vivo and provides more sensitive results in the diagnosis of oncological processes in asymptomatic stages of the disease and contribute significantly to improve cancer management. It is significant to note that these technologies include radiopharmaceuticals marked with 90 Y and 177 Lu for the therapy of patients already diagnosed by the PET technique that contribute to a significant improvement in the quality of life of patients with cancer. Our country, taking into account the importance of this technology for Health, has developed in INOR a project for the obtaining, dispensing and quality control of PET radiopharmaceuticals marked with 68 Ga for diagnosis and its therapeutic analogues marked with 177 Lu and 90Y in Conditions of Good Manufacturing Practices (GMP). The objective of the present work is to present our experiences in the implementation of the Good Practices of Manufacture of PET Radiopharmaceuticals according to regulation 16-2012 GUIDELINES ON GOOD PRACTICES OF MANUFACTURE OF PHARMACEUTICAL PRODUCTS, issued by the State Control Center for Medicines, Equipment and Devices Doctors (CECMED), a Cuban regulatory body. The implementation of the regulation considers from the preparation of personnel involved in the activity, moving through the facilities and equipment to the validation and quality control. A system for the quality assurance of the production of PET radiopharmaceuticals was implemented in accordance with Annex 5 of Regulation 16-2012 of the CECMED. This is the first experience in Cuba of the implementation of Good Manufacturing Practices of PET Radiopharmaceuticals in Hospital Radiopharmacy. The acquired experiences will be extended to the practices for the preparation of radiopharmaceuticals for the conventional Nuclear Medicine in the INOR.

  13. Modern trends in radiopharmaceuticals for diagnosis and therapy. Proceedings of a symposium

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-08-01

    The IAEA held an International Symposium on Modern Trends in Radiopharmaceuticals for Diagnosis and Therapy in Lisbon, Portugal, from 30 March to 3 April 1998. Two earlier symposia were organized on similar topics in Copenhagen, Denmark in 1973 and in Tokyo, Japan, in 1984. The proceedings of these symposia have been published and widely used as reference sources. To facilitate faster publication and more widespread availability, the IAEA has decided to publish the proceedings of this symposium as a cost-free TECDOC. The symposium was organized into 14 sessions consisting of five on {sup 99m}Tc radiopharmaceuticals, two each on therapeutic radiopharmaceuticals and radiohalogens/other isotopes and one each on bioevaluation, radiometric assay, medical isotope production, good radiopharmacy practice and technology transfer. In the proceedings the papers from multiple sessions on the same topic have been grouped together for the convenience of the reader. The papers presented in the symposium reflect current and future developments in diagnostic and therapeutic agents. The largest number of papers presented dealt with {sup 99m}Tc, highlighting its continuing importance to nuclear medicine and the role of imaging as an important tool. The emerging interest in therapeutic radiopharmaceuticals based on beta emitting short lived isotopes such as {sup 186}Re and {sup 153}Sm was evident from the papers presented in two sessions devoted to this topic. Also of steady interest was the development of agents labelled with other established isotopes, radioiodine in particular and also {sup 111}In and {sup 67}Ga. Regulation, training and good manufacturing practices are important for ensuring safety in regular use of radiopharmaceuticals and were discussed in a separate session. The production of radiopharmaceuticals has become a regular activity in many developing countries, often facilities were presented at the symposium Refs, figs, tabs

  14. Modern trends in radiopharmaceuticals for diagnosis and therapy. Proceedings of a symposium

    International Nuclear Information System (INIS)

    1998-08-01

    The IAEA held an International Symposium on Modern Trends in Radiopharmaceuticals for Diagnosis and Therapy in Lisbon, Portugal, from 30 March to 3 April 1998. Two earlier symposia were organized on similar topics in Copenhagen, Denmark in 1973 and in Tokyo, Japan, in 1984. The proceedings of these symposia have been published and widely used as reference sources. To facilitate faster publication and more widespread availability, the IAEA has decided to publish the proceedings of this symposium as a cost-free TECDOC. The symposium was organized into 14 sessions consisting of five on 99m Tc radiopharmaceuticals, two each on therapeutic radiopharmaceuticals and radiohalogens/other isotopes and one each on bioevaluation, radiometric assay, medical isotope production, good radiopharmacy practice and technology transfer. In the proceedings the papers from multiple sessions on the same topic have been grouped together for the convenience of the reader. The papers presented in the symposium reflect current and future developments in diagnostic and therapeutic agents. The largest number of papers presented dealt with 99m Tc, highlighting its continuing importance to nuclear medicine and the role of imaging as an important tool. The emerging interest in therapeutic radiopharmaceuticals based on beta emitting short lived isotopes such as 186 Re and 153 Sm was evident from the papers presented in two sessions devoted to this topic. Also of steady interest was the development of agents labelled with other established isotopes, radioiodine in particular and also 111 In and 67 Ga. Regulation, training and good manufacturing practices are important for ensuring safety in regular use of radiopharmaceuticals and were discussed in a separate session. The production of radiopharmaceuticals has become a regular activity in many developing countries, often facilities were presented at the symposium

  15. The quality of 99mTc-radiopharmaceuticals - a basic requirement in the diagnostic nuclear medicine

    International Nuclear Information System (INIS)

    Ivanova, S.; Popsavova, H.; Kostadinova, I.

    2011-01-01

    Development and application of new high quality radiopharmaceuticals (RP) are of a great significance for the development in nuclear medicine. The high quality of the radiopharmaceuticals has a major influence on the accuracy of nuclear medical examinations. Therefore, a good knowledge and application if various control methods, is essential. Radiochemical impurities affect the quality of RP most significantly and they can appear at every stage of the preparation. The aim of this review is to present the literature information concerning the quality of the most commonly used radiopharmaceuticals, labeled with 99m Tc, and all requirements for them, i.e. radiochemical, radionuclide and chemical purity. This is well-known fact that metastable isotope of Technetium is golden standard for diagnostics in nuclear medicine. Research shows that about 80% of approx. 25 million nuclear medical studies a year are performed with this radionuclide. According to the European Pharmacopoeia and to the leaflets provided with the kits, radiochemical purity must exceed 95%. The main radiochemical impurities in 99m Tc-radiopharmaceuticals are free pertechnetate ( 99m TcO 4 - ), whose presence causes accumulation of RP in the thyroid gland, stomach, gastrointestinal tract, or the salivary glands, leading to a wrong diagnosis, and reduced hydrolyzed technetium, which causes visualization of the reticulo-endothelial system. This paper contains information about the authors' experience with analyses of the radiochemical purity of the two most commonly used radiopharmaceuticals in Bulgaria - for bone and renal scintigraphy (MDA and DTPA). An Instant Thin-Layer Chromatography (ITLC) is used for this purpose. It is concluded that the high quality of the applied 99m Tc-radiopharmaceuticals can be guaranteed only with both selection of renowned manufactures, recognized by EU, and a routine daily control of the labeling and generator eluate, meeting all requirements of the manufacturer and

  16. Incorporation of radiohalogens via versatile organometallic reactions: applications in radiopharmaceutical chemistry

    Energy Technology Data Exchange (ETDEWEB)

    Srivastava, P.C.; Goodman, M.M.; Knapp, F.F. Jr.

    1985-01-01

    Factors that must be considered for the design of radiohalogenated radio-pharmaceuticals include the stability and availability of the substrate, the physical half-life of the radiohalogen and the in vivo stability of the radiolabel. Vinyl and phenyl radiohalogen bonds show more in vivo stability than the alkyl radiohalogen bonds. Consequently, a variety of methods suitable for the synthesis of tissue specific radiopharmaceuticals bearing a vinyl or phenyl radiohalogen have been developed involving the synthesis and halogenation of metallovinyl and phenyl intermediates. The halogens and metallation reactions include iodine and bromine and alanation, boronation, mercuration, stannylation, and thallation, respectively. 19 refs., 1 fig., 1 tab.

  17. Evaluation of radiochemistry purity and p H of radiopharmaceuticals in nuclear medicine services at Pernambuco, Brazil

    International Nuclear Information System (INIS)

    Andrade, Wellington; Lima, Fabiana Farias de; Santos, Poliane A.L.; Lima, Fernando Roberto de Andrade; Lima, Fabiana Farias de

    2011-01-01

    Radiopharmaceuticals are cellular or molecular structures that have a radionuclide in its composition and they are used for diagnosing or treating diseases. The evaluation of the radiochemical purity of radiopharmaceuticals is essential to produce images with artifacts free, as well as avoid unnecessary absorbed dose to the patient. Since they are administered in humans is important and necessary that they undergo rigorous quality control. Due to this fact, the norm in ANVISA RDC 38/2008 declaring the mandatory completion of a minimum of tests in routine nuclear medicine services before human administration. (author)

  18. Handling of radiopharmaceuticals drugs in hot cell: Implementation and validation of new hygiene procedures

    International Nuclear Information System (INIS)

    Levigoureux, E.; Hoffman, A.; Bolot, C.; Aulagner, G.; Brun, J.

    2012-01-01

    Exigencies associated with radiopharmaceutical drugs require validation of hygiene procedures. Different bio-cleaning processes were applied. For each, samples were collected from work surface, from preparation field and from the cap of multi-doses vial on agar contact. Twenty-two radiopharmaceutical preparations were inoculated in different liquid media. Results show that modification of bio-cleaning process enables a microbiological contamination reduction (p ≡ 0.0196). All preparations passed the sterility tests. Thus these results enabled the validation of new hygiene process in the radiopharmacy unit. (authors) [fr

  19. A 3D high-resolution gamma camera for radiopharmaceutical studies with small animals

    CERN Document Server

    Loudos, G K; Giokaris, N D; Styliaris, E; Archimandritis, S C; Varvarigou, A D; Papanicolas, C N; Majewski, S; Weisenberger, D; Pani, R; Scopinaro, F; Uzunoglu, N K; Maintas, D; Stefanis, K

    2003-01-01

    The results of studies conducted with a small field of view tomographic gamma camera based on a Position Sensitive Photomultiplier Tube are reported. The system has been used for the evaluation of radiopharmaceuticals in small animals. Phantom studies have shown a spatial resolution of 2 mm in planar and 2-3 mm in tomographic imaging. Imaging studies in mice have been carried out both in 2D and 3D. Conventional radiopharmaceuticals have been used and the results have been compared with images from a clinically used system.

  20. What Lies Within: Using Radiopharmaceuticals to Reveal and Target Diseases Hidden Inside the Human Body

    International Nuclear Information System (INIS)

    Jawerth, Nicole

    2014-01-01

    The ability to pinpoint the location and size of a cancerous mass hidden inside of a patient’s body was unthinkable less than 100 years ago. Today, with the help of special scanning machines, doctors are able to use radioactive drugs known as radiopharmaceuticals to get a glimpse inside the human body, and these pharmaceuticals can even be used in treating many health conditions. In nuclear medicine, radiopharmaceuticals play an essential role for minimally invasive diagnostic, treatment and care management procedures for many diseases, especially cancer, as well as for relieving pain associated with certain cancers

  1. Radiopharmaceuticals for palliative therapy pain; Radiofarmacos para terapia paliativa del dolor

    Energy Technology Data Exchange (ETDEWEB)

    Gaudiano, Javier [Universidad de la Republica, Montevideo (Uruguay). Centro de Medicina Nuclear

    1994-12-31

    Dissemination to bone of various neoplasms is cause of pain with poor response by major analgesics.Indications. Radiopharmaceuticals,description of main characteristics of various {beta} emitter radionuclides.Choose of patients for worm indication of pain palliative therapy with {beta} emitter radiopharmaceuticals is adequate must be careful . Contraindications are recognized.Pre and post treatment controls as clinical examination and complete serology are described.It is essential to subscribe protocols,keep patient well informed,included the physician in charge of the patient as part of the team.Bibliography.

  2. Determination and reliability of dose coefficients for radiopharmaceuticals; Ermittlung der Zuverlaessigkeit von Dosiskoeffizienten fuer Radiopharmaka

    Energy Technology Data Exchange (ETDEWEB)

    Spielmann, V.; Li, W.B.; Zankl, M.; Oeh, U.

    2015-11-15

    The dose coefficients used in nuclear medicine for dose calculations of radiopharmaceuticals are based on recommendations by ICRP (International Commission on radiological protection) and the MIRD (Medical Internal Radiation Dose Committee) using mathematical models for the temporal activity distributions in organs and tissues (biokinetic models) and mathematical models of the human body. These models using an idealized human body do not include uncertainty estimations. The research project is aimed to determine the uncertainties and thus the reliability of the dose coefficients for radiopharmaceuticals and to identify the biokinetic and dosimetric parameters that contribute most of the uncertainties.

  3. Internal dosimetry of technetium-99m-labelled radiopharmaceuticals used in clinical nuclear medicine

    Energy Technology Data Exchange (ETDEWEB)

    Roedler, H D [Freie Univ. Berlin (Germany, F.R.). Klinikum Steglitz

    1977-01-01

    For radiopharmaceuticals labelled with /sup 99m/Tc, which is the most common short-lived radionuclide used in nuclear medicine, the possible dose reduction in comparison to other radionuclides for equal administered activities is deduced from the formalism of absorbed dose calculation and compared to the actually achieved decrease of absorbed dose for the most important radiopharmaceuticals. Absorbed doses per ..mu..Ci of administered activity are tabulated for the gonads, red bone marrow, and critical organs of the adult human, the newborn, and the child of 1, 5, 10, and 15 years.

  4. Quantitative HPLC determination of [99mTc]-pertechnetate in radiopharmaceuticals and biological samples: Pt. 1

    International Nuclear Information System (INIS)

    Tianze Zhou; Hirth, W.W.; Heineman, W.R.; Deutsch, Edward

    1988-01-01

    Techniques have been developed which allow HPLC (high performance liquid chromatography) to be used for the quantitative determination of [ 99m Tc]pertechnetate in radiopharmaceuticals and biological samples. An instrumental technique accounts for 99m Tc species which do not elute from the HPLC column, while a chemical technique obviates interferences caused by Sn(II). These two techniques are incorporated into an anion exchange HPLC procedure which is applied to the determination of [ 99m Tc]pertechnetate in 99m Tc-diphosphonate radiopharmaceuticals and biological samples. (author)

  5. Parameter estimation and compartmental modelling for individualization of therapeutic dosage of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Giussani, A.; Cantone, C.

    2001-01-01

    A successful application of radiopharmaceuticals for therapy requires a patient-specific optimization of the administration activity. The intention of this contribution is to show how this is possible with a relatively limited effort, by combining an optimized experimental schedule for the collection of the anatomic and physiological data of interest and a rigorous mathematical analysis. The benefits of such an optimization will concern not only the success of the therapy, but also the radiological protection of the patients and could even be translated in a more cost-effective usage of the radiopharmaceutical available. (author)

  6. Determination of the influence factors of the radiopharmaceutical vials dimensions used for activimeter calibration at IPEN.

    Science.gov (United States)

    Martins, E W; Potiens, M P A

    2012-07-01

    This paper presents the establishment of a quality control program and correction factors for the geometry of the vials used for distribution of radiopharmaceutical and activimeters calibration. The radiopharmaceutical produced by IPEN 67Ga, 131I, 201Tl and 99mTc had been tested using two different vials. Results show a maximum variation of 22% for 201Tl, and the minimum variation was 2.98% for 131I. The correction factors must be incorporated in the routine calibration of the activimeters. Copyright © 2011 Elsevier Ltd. All rights reserved.

  7. Basic evaluation of 67Ga labeled digoxin derivative as a metal-labeled bifunctional radiopharmaceutical

    International Nuclear Information System (INIS)

    Fujibayashi, Yasuhisa; Konishi, Junji; Takemura, Yasutaka; Taniuchi, Hideyuki; Iijima, Naoko; Yokoyama, Akira.

    1993-01-01

    To develop metal-labeled digoxin radiopharmaceuticals with affinity with anti-digoxin antibody as well as Na + , K + -ATPase, a digoxin derivative conjugated with deferoxamine was synthesized. The derivative had a high binding affinity with 67 Ga at deferoxamine introduced to the terminal sugar ring of digoxin. The 67 Ga labeled digoxin derivative showed enough in vitro binding affinity and selectivity to anti-digoxin antibody as well as Na + , K + -ATPase. The 67 Ga labeled digoxin derivative is considered to be a potential metal-labeled bifunctional radiopharmaceutical for digoxin RIA as well as myocardial Na + , K + -ATPase imaging. (author)

  8. Role of a radiopharmacist in the development of a tumor-localizing radiopharmaceutical

    International Nuclear Information System (INIS)

    Briner, W.H.

    1974-01-01

    The development of a new radiopharmaceutical involves heavy responsibility relating to the safety of human lives. Although in past years the primary concern manifested by regulatory agencies was directed toward the radiation characteristics of these agents, more recent attention has been directed to the pharmaceutical quality of radioactive drugs. The technology of radiopharmaceutical design and formulation includes both aspects. Thus radiopharmacists have an exceedingly important role to play in this research and development area, for their training and experience in both the physical and biological sciences, their expertise in pharmaceutical formulation and quality control techniques, and their knowledge of laws and regulations that apply to all drugs can be invaluable. (U.S.)

  9. New radiopharmaceuticals for receptor scintigraphy and radionuclide therapy

    Energy Technology Data Exchange (ETDEWEB)

    Virgolini, I.; Traub, T.; Leimer, M.; Novotny, C.; Pangerl, T.; Ofluoglu, S.; Halvadjieva, E.; Smith-Jones, P.; Flores, J.; Li, S.R.; Angelberger, P.; Havlik, E.; Andreae, F.; Raderer, M.; Kurtaran, A.; Niederle, B.; Dudczak, R. [Vienna Univ., Vienna (Austria). Dept. of Nuclear Medicine

    2000-03-01

    In vitro data have demonstrated a high amount of receptors for various hormones and peptides on malignant cells of neuroendocrine origin. Among these, binding sites for member of the SST-family (hSSTR1-5) are frequently found, and their expression has led to therapeutic and diagnostic attempts to specifically target these receptors. Receptor scintigraphy using radiolabeled peptide ligands has proved its effectiveness in clinical practice. In addition, initial results have indicated a clinical potential for receptor-targeted radiotherapy. Based on somatostatin (SST) receptor (R) recognition, the novel radiopharmaceuticals {sup 111}In/{sup 9}0Y-DOTA-lanreotide developed at the University of Vienna as well as {sup 111}In/{sup 9}0Y-DOTA-DPhe{sup 1}-Tyr{sup 3}-octreotide (NOVARTIS) both have provided promising data for diagnosis and treatment of hSSTR-positive tumors. SSTR scintigraphy using {sup 111}In-DTPA-DPhe{sup 1}-octreotide has a high positive predictive value for the vast majority of neuroendocrine tumors and has gained its place in the diagnostic work-up as well as follow-up of patients. Here it was used {sup 111}In-DOTA-lanreotide scintigraphy in 166 patients since 1997 and have seen positive results in 93% of patients. In 42 patients with neuroendocrine tumors comparative data were obtained. As opposed to {sup 111}In-DTPA-DPhe{sup 1}-octreotide and {sup 111}In-DOTA-DPhe{sup 1}-Tyr{sup 3}-octreotide, discrepancies in the scintigraphic results were seen in about one third of patients concerning both the tumor uptake as well as tumor lesion detection. Initial results both with {sup 9}0Y-DOTA-lanreotide as well as {sup 9}0Y-DOTA-DPhe{sup 1}-Tyr{sup 3}-octreotide has pointed out the clinical potential of radionuclide receptor-targeted radiotherapy. This new therapy could offer palliation and disease control at a reduced cost. The final peptide therapy strategy is most probably cheaper than conventional radio therapies or prolonged chemo therapies. Overall

  10. The IAEA Activities on Supporting Development of Therapeutic Radiopharmaceuticals and Capacity Building in Member States

    International Nuclear Information System (INIS)

    Pillai, M.R.A.; Haji-Saeid, M.; Zaknun, J.; Ramamoorthy, N.

    2009-01-01

    The IAEA activities on supporting development of therapeutic radiopharmaceuticals are focused on identified radionuclides that can be produced in large quantities and making use of carrier molecules which can be synthesized locally or procured from commercial sources or already available in MS from other related programs. The main emphasis is on 90 Y and 177 Lu based products, which cover the hard beta energy and soft beta energy range respectively, and also since both these radionuclides can be produced in large quantities with very high specific activity and high radionuclidic purity. The services to MS are provided through implementing Coordinated Research Projects (CRP), Technical Cooperation (TC) projects, technical meetings and regional training courses in addition to documenting practically useful technical information related to these products though IAEA publications. The CRP is a group activity in which nearly 15 participants from as many countries come together to work towards an identified objective. Two of the completed CRPs in this area are: (i) Comparative evaluation of therapeutic radiopharmaceuticals (2002-2005) that focussed on the development of 'in vitro' and 'in vivo' techniques for evaluating new generation therapeutic radiopharmaceuticals; and (ii) Development of generator technologies for therapeutic radionuclides (2004-2007) that addressed technologies for 90 Sr/ 90 Y and 188 W/ 188 Re generators and which can be easily adapted by MS. The participants in the CRP on 'Comparative evaluation of therapeutic radiopharmaceuticals' used the somatostatin analogue, DOTATATE as the lead molecule for developing radiopharmaceuticals and testing the efficacy by in vitro biological assays and animal biodistribution studies. A significant outcome of the CRP was that 177 Lu-DOTATATE therapy is now practised in several of the CRP participating countries including Brazil, India, Italy, and Poland. The major outcome of the CRP on 'Development of generator

  11. Sentinel lymph node identification in breast cancer using periareolar and subdermal injection of the radiopharmaceutical in four points

    International Nuclear Information System (INIS)

    Coelho-Oliveira, Afranio; Rocha, Augusto Cesar Peixoto; Gutfilen, Bianca; Pessoa, Maria Carolina Pinheiro; Fonseca, Lea Mirian Barbosa da

    2004-01-01

    The aim of this study was to identify the sentinel node by periareolar injection of the radiopharmaceutical in four points, regardless of tumor topography. The sentinel node biopsy reduces morbidity in axillary staging. Fifty-seven sentinel node biopsies were prospectively performed in two groups: group A (25 patients) and group B (32 patients). The peritumoral injection technique was used in group A and the new injection technique in four points was used in group B. The sentinel node biopsies were studied by imprint cytology and hematoxylin and eosin staining followed by axillary lymph node dissection in all patients of group A and only in the positive cases of group B. In group A, 88% (22/25) of the sentinel nodes were identified. There was no false negative case; the sensibility and specificity were of 100%. In group B, 96% (31/32) of sentinel nodes were identified and the status of the axillary lymph nodes showed a predictive positive value of 100%. The number of sentinel nodes varied from 1 to 7, mode of 1 and median of 2.7. The hotspot area was 10 to 100 times the background radiation. The periareolar injection in four points seems to be a good lymphatic mapping method for identification of the sentinel node. We suggest the standardization of this site for injections to identify the sentinel node, although further studies to confirm these findings are necessary. (author)

  12. The WFNMB Survey on the Introduction of New Radiopharmaceuticals for Clinical Research: Snapshot of the international perspective

    International Nuclear Information System (INIS)

    Jeong, J.M.; Choe, Y.S.; Knapp, F.F. Jr.

    2007-01-01

    Development of new radiopharmaceuticals and their introduction into clinical trials ensures continuing improvement in the practice of nuclear medicine. Although it is crucial that safety and efficacy are established prior to use in humans, the characteristics of radiopharmaceuticals are quite different from other drugs since these agents are generally administered in trace, sub-pharmacological amounts. Diagnostic and therapeutic radiopharmaceutical agents are used only in restricted and controlled areas and are administered only by trained personnel. In many cases - as often for PET -- such diagnostic agents are often used in the same institution where they are prepared. Thus, regulations for the preparation and use of radiopharmaceuticals should be different from other drugs. To evaluate the current status of radiopharmaceutical regulations, we surveyed radiopharmaceutical experts and nuclear medicine societies on an international basis. A questionnaire was provided which focused on the regulations required for the in-house non-commercial preparation of new radiopharmaceutical for routine clinical use or for use in clinical trials. Responses were received from participants in 36 countries. Although both government and institutional approval are required for introduction of new radiopharmaceuticals in the majority of countries, some countries require only institutional approval. In the case of therapeutic radiopharmaceuticals, as may be expected, only physician responsibility is more often required compared with similar approval for use of diagnostic agent in these settings. The requirement of current Good Manufacturing Practice (cGMP) for PET agents was higher than with the other agents. This preponderance of cGMP requirements may be interpreted as much higher than may be expected, since many PET radiopharmaceuticals are used in-house and are prepared in the hospital by pharmaceutical compounding and not by manufacturing. Compounding is not regulated by c

  13. Development of more efficacious Tc-99m organ imaging agents for use in nuclear medicine by characterization of radiopharmaceuticals. Final report, September 1, 1992--June 30, 1998

    International Nuclear Information System (INIS)

    Heineman, W.R.; Seliskar, C.J.

    1998-01-01

    The primary goals of this project were twofold: (1) Development of a microsensor that would demonstrate the capability for in vivo monitoring of a radiopharmaceutical after its injection into a test animal; and (2) Exploration of capillary electrophoresis (CE) as a separation technique for the analysis of radiopharmaceuticals that are mixtures of different compounds. The combination of in vivo sensors for real-time monitoring of specific chemical states of a radiopharmaceutical in individual organs and CE for analysis of radiopharmaceuticals prior to injection would provide valuable information regarding the fate of an imaging agent after administration. Such information should give insight into strategies for the development of more efficacious radiopharmaceuticals

  14. Dosimetric aspects of the treatment of metastatic bone pain with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Garcia, T.; Marti, J. F.; Olivas, C.; Vercher, J. L.; Repetto, R.; Bello, P.

    2014-01-01

    Within the context of treatment of metastatic bone pain with bone seeking radiopharmaceuticals, this paper expounds the results of an analysis of available molecules (both approved for clinical use or still under study) intended to obtain a detailed comparison of their dosimetric characteristics. These can be used to supplement the list of already know differences between them, such as efficacy, appearance and length of the palliative effect, eventual tumoricidal effect, myelotoxicity, sale price and availability. Seven radiopharmaceuticals have been analysed, five of them are based on beta emission radionuclides: 3 2P, 1 53Sm, 1 86Re and 1 88Re and the other two ones are based on high Linear energy Transference emission radionuclides: 1 17mSn and 2 23Ra a series of estimates of the main dosimetric parameters for each radiopharmaceutical analysed have been obtained. The values obtained might be worth being incorporated to the risk/benefit analysis that precedes every choice of the specific radiopharmaceutical to be used with an individual patient. In this way, we hope these results will be of some help for those Nuclear Medicine specialists interested in the treatment of oncological bone pathologies. (Author)

  15. Study of surface potential contamination in radioisotope and radiopharmaceutical production facilities and alternative solutions

    International Nuclear Information System (INIS)

    Suhaedi Muhammad; Rimin Sumantri; Farida Tusafariah; Djarwanti Rahayu Pipin Soedjarwo

    2013-01-01

    Radioisotope and radiopharmaceutical production facilities that exist in their operations around the world in the form of radiological impacts of radiation exposure, contamination of surface and air contamination. Given the number of existing open source in radioisotope and radiopharmaceutical production facility, then the possibility of surface contamination in the work area is quite high. For that to protect the safety and health of both workers, the public and the environment, then the licensee must conduct an inventory of some of the potential that could result in contamination of surfaces in radioisotope and radiopharmaceutical production facilities. Several potential to cause surface contamination in radioisotope and radiopharmaceutical production facilities consist of loss of resources, the VAC system disorders, impaired production facilities, limited resources and lack of work discipline and radioactive waste handling activities. From the study of some potential, there are several alternative solutions that can be implemented by the licensee to address the contamination of the surface so as not to cause adverse radiological impacts for both radiation workers, the public or the environment. (author)

  16. Validation of the method for investigation of radiopharmaceuticals for in vitro use

    International Nuclear Information System (INIS)

    Vranjes, S; Jovanovic, M.; Orlic, M.; Lazic, E. . E-mail address of corresponding author: sanjav@vin.bg.ac.yu

    2005-01-01

    The aim of this study was to validate analytical method for determination of total radioactivity and radioactive concentration of 125 I-triiodotironin, radiopharmaceutical for in vitro use. Analytical parameters: selectivity, accuracy, linearity and range of this method were determined. Values obtained for all parameters are reasonable for analytical methods, therefore this method could be used for farther investigation. (author)

  17. Production of radionuclides and radiopharmaceuticals at the Argentine Atomic Energy National Commission

    International Nuclear Information System (INIS)

    Mitta, A.E.A.; Bonetto, Oscar; Kurcbart, Horacio; Mancini, Alberto; Marquez, R.O.; Palcos, M.C.; Quihillalt, E.L.; Salas, G.N.B. de; Suner, A.A.; Troparevsky, M.L.P. de.

    1978-03-01

    The production of radionuclides and radiopharmaceuticals at the CNEA is described, as well as the preparation of reagent's sets, and informations is given on the preparation of Tc-99m and In-113m generators. Some figures of the production of 1974-1976 are given. (author) [es

  18. Harvard-MIT research program in short-lived radiopharmaceuticals. Technical progress report, 1991

    Energy Technology Data Exchange (ETDEWEB)

    Adelstein, S.J.

    1991-12-31

    This report presents research on radiopharmaceuticals. The following topics are discussed: antibody labeling with positron-emitting radionuclides; antibody modification for radioimmune imaging; labeling antibodies; evaluation of technetium acetlyacetonates as potential cerebral blood flow agents; and studies in technetium chemistry. (CBS)

  19. Information manual on the microbiological aspects of good manufacturing practices for radiopharmaceutical preparations

    International Nuclear Information System (INIS)

    Saunders, M.

    1985-04-01

    A description is given of clean air units, clean room garments, disinfectants and types of contamination likely to affect radiopharmaceutical preparations and measures for their control. Specific precautions for the manufacture at Lucas Heights of sterile, pyrogen-free injectables and oral preparations of low microbial contamination are described

  20. Fluorine-18 radiopharmaceuticals beyond [F-18]FDG for use in oncology and neurosciences

    NARCIS (Netherlands)

    Coenen, H. H.; Elsinga, P. H.; Iwata, R.; Kilbourn, M. R.; Pillai, M. R. A.; Rajan, M. G. R.; Wagner, H. N.; Zaknun, J. J.

    2010-01-01

    Positron emission tomography (PET) is a rapidly expanding clinical modality worldwide thanks to the availability of compact medical cyclotrons and automated chemistry for the production of radiopharmaceuticals. There is an armamentarium of fluorine-18 (F-18) tracers that can be used for PET studies

  1. Preparation of gallium-68 radiopharmaceuticals for positron tomography. Progress report, November 1, 1980-December 31, 1981

    International Nuclear Information System (INIS)

    Welch, M.J.

    1981-06-01

    Although the germanium-68 → gallium-68 generator is probably the only source of positron-emitting radionuclides that could enable the widespread application of positron tomography, the commercially available 68 Ga/ 68 Ge generator system suffers from several major disadvantages. The most important of these is that the generator is eluted with EDTA, which forms a very strong chelate with gallium. In order to produce radiopharmaceuticals other than 68 Ga-EDTA, it is first necessary to break the stable EDTA complex and remove all traces of EDTA. This procedure adds several steps and a significant amount of time to procedures for preparing 68 Ga-radiopharmaceuticals. Several years ago, we developed a new generator using a solvent extraction system which produces 68 Ga-oxine (8-hydroxyquinoline), a weak chelate. We have also carried out studies to compare generator systems which produce 68 Ga in an ionic form. Using the gallium-68 eluted from these various generator systems, several 68 Ga-labeled radiopharmaceuticals have been synthesized and tested in vitro and in vivo. In addition, attempts have been made to design and synthesize a lipophilic ligand for gallium-68. The stability of radiogallium complexed with a series of potentially lipophilic complexing agents has been studied using chromatographic techniques and in vivo distribution data. The potential of these complexing agents for altering the biodistribution of gallium radiopharmaceuticals has also been investigated

  2. A study of effluent control technologies employed by radiopharmaceutical users and suppliers

    International Nuclear Information System (INIS)

    Leventhal, L.; Slider, J.; Chakoff, E.; Chen, J.I.; Savage, E.

    1980-01-01

    The quantities of radiopharmaceuticals produced for in-vivo diagnostic and therapy procedures has been estimated to be growing at the rate of 16% per year, based on 1978 sales figures. Nuclear medicine facilities are experiencing an average annual growth rate of 5% per year. The principle radionuclides produced and used for nuclear medicine are 131 I, 131 Xe, and sup(9m)Tc. Of particular concern is that amount of these radionuclides which might become airborne and escape into the environment during the process of manufacture or during aliquotting or administration by hospital personnel. Therefore, a study was made of the effluent control technology employed by radiopharmaceutical suppliers and users. Generally, the means used to control airborne radioactive effluents fall into two classes according to function. The controls either dilute and direct the effluent to a specific point of release or hold up the effluent to reduce by decay the amount of radioactivity released. Radiopharmaceutical suppliers and hospitals were contacted, and a survey made of the control technology used. The classes and types of effluent control equipment and their general characteristics, cost and effectiveness were determined. It was concluded that control equipment was readily available, reliable, and effective in reducing radioactive releases from radiopharmaceutical facilities. (author)

  3. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    Energy Technology Data Exchange (ETDEWEB)

    Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral, E-mail: maryellelg@hotmail.com [PPG BioSaude, Universidade Luterana do Brasil, Canoas, RS (Brazil); Rocha, Bruna Oliveira [Faculty of Biology, Universidade Luterana do Brasil, Canoas, RS (Brazil); Santos-Oliveira, Ralph [Institute of Radiopharmacy Research, Universidade Estadual da Zona Oeste, Rio de Janeiro, RJ (Brazil)

    2014-04-15

    Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

  4. A Study on the Quality Control of 18F-FDG Radiopharmaceutical

    International Nuclear Information System (INIS)

    Kim, Ssang Tae; Yong, Chul Soon; Han, Eun Ok

    2010-01-01

    The types of test items which were recorded in this test report of quality control domestic 18 F-FDG radiopharmaceutical which consisted of 13 different types: appearance, half-life, radioactive heterokaryosis, radiochemical Confirmation (measure of Rf value), radiochemical Purity, Ethanol, Acetonitrile, Kryptofix, Aluminium, pH, Endotoxin, aseptic test, and radioactivity·ml-1. The record was fully recorded in 'appearance', 'radioactive heterokaryosis', 'pH', 'Endotoxin', and 'aseptic test'. In 'half-life', 'radiochemical Confirmation (measure of Rf value), 'radiochemical Purity', 'Ethanol', 'Acetonitrile', 'Kryptofix', 'Aluminium', 'radioactivity·ml-1', there were differences in records of each manufacturing business on radioactive medicine and medical supplies. The result of the test showed all 13 items of quality control test were 100% suitable on the basis of recorded data. There were more radiopharmaceutical made in the laboratory than in hospitals and businesses and in for result of suitability test, the laboratory showed higher suitability than did the hospitals or businesses. Domestically, there are differences of the test report items in the safety of radiopharmaceutical of each facility, and since it is not standardized, supplements are needed. To submit standardized test reports of quality guarantee in radiopharmaceutical, GMP of U.S. and CE Mark of Europe should be referred as well as receiving advice from professionals to standardize as suitable domestic standard

  5. Radiolabeling of human platelets using four radiopharmaceuticals with Tc-99m

    International Nuclear Information System (INIS)

    Portillo L, M.C.; Godoy, C.

    1991-01-01

    The present investigation work has been done in an evaluation of four different radiopharmaceuticals with Tin II (Glucoheptonate, Pyrophosphate, Citrate and DTPA), with the purpose of determining which one of the four would be obtained a higher rate of radiolabeling of platelets with Tc-99m. In order to evaluate the four radiopharmaceuticals it was procede to the separation and labeling of the human platelets. It was worked with samples of blood from five pacients, and the platelets from each one of them were labeled with the radiopharmaceuticals-Tc-99m. Then was observed a significant difference among the four radiopharmaceuticals studied, with a reliable level of 0.05 being the Glucoheptonate-Tc-99m the best to label platelets, obtaining with the same 50.23% of labeling efficiency, while for DTPA, Pyrophosphate and Citrate, It was obtained 33.42%, 29.82% and |2.62% respectively. Also, it was studied the biodistribution of the labeled platelets, using Glucoheptonate-Tc-99m as a radiopharamceutical. The biodistribution was studied in white mice at different times and it was founded that the place of biodistribution of the labeled platelets is given in greater percentage in the liver, spleen, lungs and kydneis. (Author)

  6. Method for preparing 99mTc-labelled radiopharmaceuticals for myocardial scintigraphy

    International Nuclear Information System (INIS)

    Seifert, S.; Syhre, R.; Muenze, R.

    1987-01-01

    Radiopharmaceuticals which preferably concentrate in myocardial tissue are prepared, in particular technetium compounds with the reducing ligand molecule DMPE. A method is introduced to convert pertechnetate in one step into the proposed compound by means of a saline, slow-oxidizing and lyophilized form of the reducing ligand DMPE, preferably DMPE x 2HCl

  7. The added value of Good Manufacturing Practices (GMP) in the production of radiopharmaceuticals

    NARCIS (Netherlands)

    Gerrits, Edwin; Woerdenbag, Herman; Luurtsema, Geert; de Hooge, Marjolijn; Boersma, Hendrikus

    2017-01-01

    Manufacturers of medicinal products including radiopharmaceuticals have to follow regulations from their governmental organizations as well as professional societies to ensure built-in quality combined with patient safety issues. This chapter is a concise review of Good Manufacturing Practices (GMP)

  8. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    International Nuclear Information System (INIS)

    Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral; Rocha, Bruna Oliveira; Santos-Oliveira, Ralph

    2014-01-01

    Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

  9. The quality control of technetium-99m radiopharmaceuticals produced at the AAEC Research Establishment

    International Nuclear Information System (INIS)

    Farrington, K.J.

    1983-08-01

    The methods of quality control used for technetium-99m radiopharmaceuticals produced at the AAEC Research Establishment are described for both non-fission and fission derived sources of sodium pertechnetate, technetium-99m labelled radipopharmaceuticals, and reagent kits produced for technetium-99m labelling

  10. Workshop on the first response in a radiological emergency. Radiopharmaceuticals transport. Tabletop exercises

    International Nuclear Information System (INIS)

    2011-01-01

    The purpose of this exercise is that the participants can apply their knowledge in a transport accident. A lorry that was transporting radiopharmaceuticals collided with other vehicles and a fire occurs. The first responders have to know who are the actors involved in the radiological emergency

  11. Determination of Sn in 99mTc Radiopharmaceutical Kits by Polarographic Methods

    International Nuclear Information System (INIS)

    Castro, M.; Cruz, J.; Sanchez, M.

    2009-01-01

    Kits of 99 m Tc radiopharmaceuticals are used in nuclear medicine for diagnosis of different diseases. Sn (II) is one of the essential components in their formulations, which is used for reduction 99 m Tc-pertechnetate in cold kits for on-site preparation 99 m Tc-pertechnetate radiopharmaceuticals. Usually, these cold kits contain different additives (complexing agents, antioxidants, buffers, etc.) and the amount of Sn (II) varies from kit to kit. The determination of Sn in these products is essential in assessing their quality. We report here the development of a new polarographic method for the determination of Sn (II) and total Sn in representative radiopharmaceuticals kits (for the content of Sn and chemical composition) produced at the Center of Isotopes of Cuba (CENTIS). These methods were validated by analysis of variance and recovery techniques. From the results of the validation, the characteristic functions of uncertainties and fits are considered for the established methods, which give the necessary evidences to demonstrate the usefulness of these methods according to the current trends in Analytical Chemistry. This work provides practical results of great importance for CENTIS. After the speciation of Sn in the MAG3 radiopharmaceuticals kit is inferred that the production process is affected by uncontrolled factors that influence in the product stability, which demonstrates the necessity for analytical tools for the characterization of products and processes. (Author) 57 refs.

  12. Report and recommendations on the requirements for postgraduate training in radiopharmacy and radiopharmaceutical chemistry 1989

    International Nuclear Information System (INIS)

    Cox, P.H.; Coenen, H.H.; Deckart, H.; Feuger, G.F.; Hesslewood, S.R.; Kristensen, K.; Komarek, P.; Meyer, G.J.; Stocklin, G.; Schubinger, P.A.

    1990-01-01

    The basic information concerning the status of postgraduate training in the radiopharmaceutical sciences contained in this report was compiled from the proceedings of a Workshop on Postgraduate Training in Radiopharmacy organised by the Committee on Radiopharameuticals [EANM Task Group] in Rotterdam in April 1989 under the auspices of The Council of Europe. The implications of this information were discussed at a meeting of the Committee in Strasbourg in August 1989 together with representatives from a number of European radiochemistry groups. From these discussions it was concluded that there was a strong case to propose standards for minimal training requirements for radiopharmacy and radiochemistry which would be applicable to all European countries. The Committee also found it desirable that the EANM should use its influence to obtain formal recognition of the professional responsibilities of the radiopharmaceutical chemist with respect to the production and control of short-lived, cyclotron-produced radiopharmaceuticals. This report gives an inventory of the current situation with regard to the training in radiopharmacy and radiopharmaceutical chemistry which is available in Europe and makes proposals for the establishment of a European postgraduate training programme. The programme is based upon a number of theoretical and practical teaching modules which can be adapted to meet the training requirements for pharmacists, chemists, physicians and other graduate professions. (orig.)

  13. Acquisition of biokinetic data for internal dose calculations for some novel radiopharmaceuticals

    International Nuclear Information System (INIS)

    Smith, T.; Zanelli, G.D.; Crawley, C.W.

    1986-01-01

    Estimation of radiation dose commitment, expresses as an effective dose equivalent, is a prior requisite to the application for a license to administer radiopharmaceuticals and, therefore, in the case of novel radiopharmaceuticals is leading to an increasing awareness of the need for dosimetry-orientated studies. In this laboratory potential new radiopharmaceuticals are investigated initially by animal studies to assess the possible distribution in man, and subsequently in controlled volunteer studies designed to obtain the maximum possible amount of biokinetic data to allow accurate estimation of radiation dose. A variety of techniques are used for this purpose, including profile counting, partial and whole-body scanning by LFOV gamma camera and whole-body counting, in addition to the analysis of radioactivity in blood and excreta. The use of these techniques is illustrated for the acquisition of biokinetic data and subsequent dosimetry of three novel radiopharmaceuticals: 77 Br-p-bromospiperone (quantification of dopamine receptors in the brain). 99 Tc/sup m/-porphyrins and 99 Tc/sup m/ DEPE (a possible novel blood pool marker for MUGA studies). 14 references, 14 figures, 2 tables

  14. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    Directory of Open Access Journals (Sweden)

    Maryelle Moreira Lima Gamboa

    2014-04-01

    Full Text Available Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ or positrons emitter (β+, linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64. In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs.

  15. Radio-pharmaceuticals for human use: the legal framework and the clinical indications authorised in Spain

    International Nuclear Information System (INIS)

    Cortes-Blanco, A.; Esteban Gomez, J

    2003-01-01

    The inclusion of radio-pharmaceuticals in the health legislation represented a significant change because of the obligation, for the first time, to undergo a registration process to enable them to be marketed. It also served to regulate clinical investigation using these drugs, and the prior evaluation they must undergo in other to obtain official health clearance. (Author) 27 refs

  16. Implementation of a metrology programme to provide traceability for radionuclides activity measurements in the CNEN Radiopharmaceuticals Producers Centers

    Energy Technology Data Exchange (ETDEWEB)

    Andrade, Erica A.L. de; Braghirolli, Ana M.S.; Tauhata, Luiz; Gomes, Regio S.; Silva, Carlos J., E-mail: erica@ien.gov.br [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil); Delgado, Jose U.; Oliveira, Antonio E.; Iwahara, Akira, E-mail: ealima@ird.gov.br [Instituto de Radioprotecao e Dosimetria (IRD/CNEN-RJ), Rio de Janeiro, RJ (Brazil)

    2013-07-01

    The commercialization and use of radiopharmaceuticals in Brazil are regulated by Agencia Nacional de Vigilancia Sanitaria (ANVISA) which require Good Manufacturing Practices (GMP) certification for Radiopharmaceuticals Producer Centers. Quality Assurance Program should implement the GMP standards to ensure radiopharmaceuticals have requirements quality to proving its efficiency. Several aspects should be controlled within the Quality Assurance Programs, and one of them is the traceability of the Radionuclides Activity Measurement in radiopharmaceuticals doses. The quality assurance of activity measurements is fundamental to maintain both the efficiency of the nuclear medicine procedures and patient and exposed occupationally individuals safety. The radiation doses received by patients, during the nuclear medicine procedures, is estimated according to administered radiopharmaceuticals quantity. Therefore it is very important either the activity measurements performed in radiopharmaceuticals producer centers (RPC) as the measurements performed in nuclear medicine services are traceable to national standards. This paper aims to present an implementation program to provide traceability to radionuclides activity measurements performed in the dose calibrators(well type ionization chambers) used in Radiopharmaceuticals Producer Center placed in different states in Brazil. The proposed program is based on the principles of GM Pand ISO 17025 standards. According to dose calibrator performance, the RPC will be able to provide consistent, safe and effective radioactivity measurement to the nuclear medicine services. (author)

  17. A Survey on the Usage and Demand of Medical Radioisotope and Radiopharmaceuticals in Malaysia

    International Nuclear Information System (INIS)

    Muhammad Fakhrurazi Ahmad Fadzil; Siti Selina Abdul Hamid; Siti Najila Mohd Janib; Azahari Kasbollah; Syed Asraf Fahlawi Wafa

    2015-01-01

    Medical radioisotope is a small quantity of radioactive substance used in safe, cost effective, for the purpose of diagnostic and therapy of various diseases. In Malaysia, the emerging of new nuclear medicine centers or institutions in both government and private sectors rose abruptly for the past few years. Currently, there are no data available on the usage and demand of medical radioisotope or radiopharmaceuticals. Understanding the usage trending and demand of radiopharmaceuticals and medical radioisotope is essential when related to technology changes in order to meet the market size of these radiopharmaceuticals. Survey result found out that the highest demand and the highest usage among all radioisotopes are Technetium-99m and Radioiodine isotopes such as the Iodine-1331, Iodine131 MIBG, Iodine-123 and Iodine-123 MIBG. Currently, most of the medical isotopes and radiopharmaceuticals are currently imported. Technetium-99m is the backbone of nuclear medicine whereby more than 80 % of Nuclear Medicine services utilize this radioisotope. Technetium-99m supply chain is unstable globally and in coming future, two main reactors (Canada and Holland) that produces 60 % of world Molybdenum-99 will shut down the operation and supply of Molybdenum-99 will be disrupted. As for radioiodine services, currently, Iodine-123 can't be obtained in Malaysia and neighboring countries due to its short half-life, Iodine-123 is useful in diagnostic of thyroid related diseases. As for PET services, the highest demands are F-18 FDG and Gallium-68 Generator for the moment. However the survey data still did not include most of the PET centers in the Klang Valley, northern area (Penang) and the new upcoming PET center in Southern Region (Malacca and Johor). It is important for Malaysia to self-produced medical radioisotope and radiopharmaceuticals to meet the market and local demand of these medical isotopes. (author)

  18. Current status of production and research of radioisotopes and radiopharmaceuticals in Indonesia

    International Nuclear Information System (INIS)

    Soenarjo, Sunarhadijoso; Tamat, Swasono R.

    2000-01-01

    The use of radioactive preparation in Indonesia has sharply increased during the past years, indicated by increase of the number of companies utilizing radioisotopes during 1985 to 1999. It has been clearly stressed in the BATAN's Strategic Plan for 1994-2014 that the production of radioisotopes and radiopharmaceuticals is one of five main industrial fields within the platform of the Indonesian nuclear industry. Research programs supporting the production of radioisotopes and radiopharmaceuticals as well as development of production technology are undertaken by the Research Center for Nuclear Techniques (RCNT) in Bandung and by the Radioisotope Production Center (RPC) in Serpong, involving cooperation with other research center within BATAN, universities and hospitals as well as overseas nuclear research institution. The presented paper describes production and research status of radioisotopes and radiopharmaceuticals in Indonesia after the establishment of P.T. Batan Teknologi in 1996, a government company assigned for activities related to the commercial application of nuclear technology. The reviewed status is divided into two short periods, i.e. before and after the Chairman Decree No. 73/KA/IV/1999 declaring new BATAN organizational structure. Subsequent to the Decree, all commercial requests for radioisotopes and radiopharmaceuticals are fulfilled by P.T. Batan Teknologi, while demands on novel radioactive preparations or new processing technology, as well as research and development activities should be fulfilled by the Center for the Development of Radioisotopes and Radiopharmaceuticals (CDRR) through non-commercial arrangement. The near-future strategic research programs to response to dynamic public demand are also discussed. The status of research cooperation with JAERI (Japan) is also reported. (author)

  19. Current status of production and research of radioisotopes and radiopharmaceuticals in Indonesia

    Energy Technology Data Exchange (ETDEWEB)

    Soenarjo, Sunarhadijoso; Tamat, Swasono R. [Center for Development of Radioisotopes and Radiopharmaceuticals, National Nuclear Energy Agency (BATAN), Kawasan Puspiptek, Serpong, Tangerang (Indonesia)

    2000-10-01

    The use of radioactive preparation in Indonesia has sharply increased during the past years, indicated by increase of the number of companies utilizing radioisotopes during 1985 to 1999. It has been clearly stressed in the BATAN's Strategic Plan for 1994-2014 that the production of radioisotopes and radiopharmaceuticals is one of five main industrial fields within the platform of the Indonesian nuclear industry. Research programs supporting the production of radioisotopes and radiopharmaceuticals as well as development of production technology are undertaken by the Research Center for Nuclear Techniques (RCNT) in Bandung and by the Radioisotope Production Center (RPC) in Serpong, involving cooperation with other research center within BATAN, universities and hospitals as well as overseas nuclear research institution. The presented paper describes production and research status of radioisotopes and radiopharmaceuticals in Indonesia after the establishment of P.T. Batan Teknologi in 1996, a government company assigned for activities related to the commercial application of nuclear technology. The reviewed status is divided into two short periods, i.e. before and after the Chairman Decree No. 73/KA/IV/1999 declaring new BATAN organizational structure. Subsequent to the Decree, all commercial requests for radioisotopes and radiopharmaceuticals are fulfilled by P.T. Batan Teknologi, while demands on novel radioactive preparations or new processing technology, as well as research and development activities should be fulfilled by the Center for the Development of Radioisotopes and Radiopharmaceuticals (CDRR) through non-commercial arrangement. The near-future strategic research programs to response to dynamic public demand are also discussed. The status of research cooperation with JAERI (Japan) is also reported. (author)

  20. A Survey on the Usage and Demand of Medical Radioisotope and Radiopharmaceuticals in Malaysia

    International Nuclear Information System (INIS)

    Muhammad Fakhrurazi Ahmad Fadzil; Siti Selina Abdul Hamid; Siti Najila Mohd Janib; Azahari Kasbollah; Syed Asraf Fahlawi Wafa

    2016-01-01

    Medical radioisotope is a small quantity of radioactive substance used for the purpose of diagnostic and therapy of various diseases. In Malaysia, the emerging of new nuclear medicine centers or institutions in both government and private sectors rose abruptly for the past few years. Currently, there are no data available on the usage and demand of these medical radioisotope or radiopharmaceuticals. The aim of this study is to assess current medical radioisotopes and radiopharmaceuticals usage and also to provide data on current medical radioisotope and radiopharmaceuticals demand for both private and government hospitals or institutions in Malaysia. A survey for a period of 3 months was conducted across Malaysia. The survey was divided into five (5) main parts and it was distributed among health care professionals involved working with medical radioisotope and radiopharmaceuticals in private, government and university based hospitals or institutions and was distributed manually either by hand, mail or e-mail. Data is presented in either pie chart or bar chart. Survey results found out that the highest demand and the highest usage among all radioisotopes are Technetium-99m and radioiodine isotopes such as the iodine-131, iodine-131 MIBG, iodine-123 and iodine-123 MIBG. Technetium-99m is the backbone of nuclear medicine whereby more than 80 % of Nuclear Medicine services utilize this radioisotope. Technetium-99m supply chain is unstable globally and in coming future, two main reactors that produce 60 % of world Molybdenum-99 will shut down and the supply of molybdenum-99 will be disrupted. In radioiodine services, currently, Iodine-123 cannot be obtained in Malaysia and neighboring countries due to its short half-life. Iodine-123 is useful in diagnostic of thyroid related diseases. As for PET services, the highest demands are F-18 FDG and gallium-68 Generator. It is important for Malaysia to self-produced medical radioisotope and radiopharmaceuticals to meet the

  1. Preparation and evaluation of radiopharmaceuticals for infection imaging

    International Nuclear Information System (INIS)

    Ferro-Flores, G.; Garcia-Salinas, L.; Arteaga-Murphy, C.; Pedraza-Lopez, M.; Altamirano-Bustamante, P.; Melendez-Alafort, L.

    2002-01-01

    Aim: In this study Tc-99m labeled ubiquicidin peptide (UBI), DTPA-bisBiotin and ciprofloxacin were prepared and compared as their biodistribution and ability to detect and differentiate infection from a sterile inflammatory process in rats. Material and Methods: Human antimicrobial peptide, UBI 29-41, (Leiden University Medical Center, The Netherlands), was dissolved in 1 M sodium acetate buffer pH 5.2 (1 mg/200μL). For Tc-99m labeling 10 μL was added to a vial containing 3 μL of a fresh 1 mg/mL solution of stannous chloride in 10 mM HCl. To this was added 4 μL of a solution of 1.0 mg of NaBH 4 per mL of 0.1 M NaOH, followed by 99m Tc-pertechnetate in a volume of 100-1000 μL, obtaining a final pH between 8 and 9. DTPA-bisBiotin (Sigma),1mg, was dissolved in 100 μL of 1 M sodium acetate buffer pH 6. For labeling 50 μL was added to a vial containing 99m Tc-pertechnetate in a volume of 10-20 μL. To this was added 2 μL of a fresh 1 mg/mL solution of stannous chloride in 10 mM HCl (final pH=6.0). Ciprofloxacin (Bayer), 10 mg, were dissolved in 5 mL of 0.9 % NaCl solution. Formamidine sulphonic acid, 10 mg, were dissolved in 6.25 mL of saline. From each solution 0.5 mL were withdrawn, mixed, and the pH adjusted to 8 with 0.5 M NaOH. Thereafter 0.5 mL of 99m Tc-pertechnetate was added. The reaction mixture was heated at 92 0 C during 10 min. The final pH was 7.0. Sixty six Wistar rats with bacteria induced infection (Staphylococcus aureus)/inflammation (Heat killed Klebsiella pneumoniae), were used to study the biodistribution of radiopharmaceuticals. Results: The radioactivity recovery for 99m Tc-UBI was 98 ± 3 % determined by reverse phase HPLC and radiochemical purity 96 ± 2 % determined by SepPak cartridge. Considering that into UBI structure five of the thirteen total amino acids are Arginine (R) (which represents free -NH 2 groups) and three of them almost beside Lysine (K), a possible molecular structure for 99m Tc-UBI was calculated and simulated by

  2. A novel technique to reduce staff exposure when preparing radiopharmaceuticals

    International Nuclear Information System (INIS)

    Collins, P.J.; Tsopelas, C.; Blefari, C.

    2003-01-01

    Full text: Staff receive considerable radiation exposure to the hands when withdrawing activity from the milking vial for reconstitution of radiopharmaceuticals. This exposure is due not only to the syringe activity, but also to the remaining, higher activity in the vial contained in the lead pot. A new technique has been developed, which involves withdrawing activity through a small hole (2.5 mm diameter) in the lid of the lead pot, with the use of a syringe bearing a long needle (0.8 x 38 mm), and a sterile blunt plastic cannula (Becton Dickinson and Co.) as the needle guide. We have investigated the effect of using this modified lid on radiation exposure at the hand position. A scintillation camera (General Electric Millenium MPR) was used to obtain count (an approximation for radiation dose) profiles using 99mTc sources. The profiles showed counts as a function of distance perpendicular to the axis of the vial and syringe. The simplest orientation was used in the initial experiments, with the syringe needle passing through the lid hole into the vial in the lead pot, which was facing upwards and resting on a flat surface. This is the usual orientation when redispensing activity back into a vial. The camera, without the collimator, was positioned 2 mm above the syringe plunger to acquire the images. The distance for the mid-point of the syringe and vial activities to the camera face was 9.3 and 21.1 cm respectively. To simulate common working levels, the ratio of activity in the vial to activity in the syringe was 20:1, and low activities (< 1 MBq) were used to avoid dead-time errors. A15 minute images was acquired, with and without the modified lid. In another experiment non-radioactive saline solution was used in the syringe to determine the contribution to radiation exposure from the milking vial in the pot, both with and without the modified lid. The modified lid is highly effective in reducing exposure from the milking vial, with a count reduction of more

  3. Harvard-MIT research program in short-lived radiopharmaceuticals. Progress report, March 1, 1983-February 29, 1984

    International Nuclear Information System (INIS)

    Adelstein, S.J.; Brownell, G.L.

    1984-02-01

    This report describes research efforts towards the achievement of a clearer understanding of the solution chemistry of technetium in order to facilitate the design of future clinical agents labeled with Tc-99m, the development of new receptor binding radiopharmaceuticals for the in vivo assessment of insulin receptors and for imaging the adrenal medulla and the brain, the examination of the utility of monoclonal antibodies and liposomes in the design of radiopharmaceuticals for diagnosis and therapy, and the synthesis of short-lived positron-emitting radiopharmaceuticals for transverse imaging of regional physiological processes

  4. The radiopharmaceuticals labelled with technetium-99m and the radiopharmacy; Les radiopharmaceutiques marques au technetium-99m et la radiopharmacie

    Energy Technology Data Exchange (ETDEWEB)

    Bodenant, V

    1998-10-01

    In less than fifty years, the place of nuclear medicine is become primordial. Among all the radiopharmaceuticals used in nuclear medicine, the technetium-99m is the most used because of its physico-chemical properties and its great availability with the molybdenum-99m - technetium-99m generator. Since 1992, the radiopharmaceuticals, the packages, the generators are included in the pharmaceutic monopole. They are now under the reliability of the radio-pharmacist. This thesis has for object to introduce these different radiopharmaceuticals labelled with technetium-99m and to show the primordial place of the radio-pharmacist in a service of nuclear medicine. (N.C.)

  5. Preparation and in vitro evaluation of 177Lu-iPSMA-RGD as a new heterobivalent radiopharmaceutical

    International Nuclear Information System (INIS)

    Escudero-Castellanos, Alondra; Universidad Autonoma del Estado de Mexico, Toluca, Estado de Mexico; Ocampo-Garcia, B.E.; Ferro-Flores, Guillermina; Santos-Cuevas, C.L.; Isaac-Olive, Keila; Olmos-Ortiz, Andrea; Garcia-Quiroz, Janice; Garcia-Becerra, Rocio; Diaz, Lorenza

    2017-01-01

    This study aimed to synthesize a new 177 Lu-iPSMA-RGD heterobivalent radiopharmaceutical, as well as to assess the in vitro radiopharmaceutical potential to target cancer cells overexpressing PSMA and α(v) β(3) integrins. The radiotracer prepared with a radiochemical purity of 98.8 ± 1.0% showed stability in human serum, specific recognition with suitable affinity to PSMA and α(v)β(3) integrins, and capability to inhibit cancer cell proliferation and VEGF signaling (antiangiogenic effect). Results warrant further preclinical studies to establish the 177 Lu-iPSMA-RGD potential as a dual therapeutic radiopharmaceutical. (author)

  6. Analytical methods for determination of radiochemical and radionuclidic purity of radiopharmaceuticals containing sup(99m)Tc and sup(113m)In. Part of a coordinated programme on radiopharmaceuticals

    International Nuclear Information System (INIS)

    Galatzeanu, I.

    1974-01-01

    The obtained results on radiochemical and radionuclidic purities determination of sup(99m)Tc and sup(113m)In-radiopharmaceuticals proved to be a good tool for small hospital units and laboratories in satisfying their duty to improve the quality control. The complicated behaviour of technetium in aqueous solutions during the preparation of radiopharmaceuticals, needs further research work to elucidate the mechanisms of interaction of reduced species with media and their disproportionation

  7. Development of an injectable formulation for the preparation of radiopharmaceutical 68Ga-DOTA-Sar gastrin

    International Nuclear Information System (INIS)

    Castillo P, M.

    2015-01-01

    The CCK2 receptor (cholecystokinin) is located in areas of the central and peripheral nervous system and is over expressed in several types of human cancer, as medullar thyroid, lung and ovarian carcinomas. One of the endogenous ligands for the CCK2 receptor is the gastrin, so that radiolabeled peptides analogues to gastrin as Sar gastrin (Gln-Gly-Pro-Trp-Leu-Glu-Glu-Glu-Glu-Glu-Ala-Tyr-Gly-Trp-Nle-Asp-Phe-NH 2 ) have been proposed as potential diagnostic radiopharmaceuticals for obtaining tumors images with CCK2 receptors over expressed. The 68 Ga is an ideal candidate for the peptides radiolabelled and has favorable characteristics to be used for diagnostic purposes by imaging with Positron emission tomography (PET). This work aimed to verify the technical documentation of the production process of radiopharmaceutical 68 Ga-DOTA-Sar gastrin for its sanitary registration before the Comision Federal contra Riesgos Sanitarios (COFEPRIS) in Mexico. For optimization of the production process was assessed a factorial design of two variables with mixed levels (27 combinations), where the dependent variable was the radiochemical purity. The analytical method used for evaluating the content of Sar gastrin peptide in the injectable formulation was also validated by High-performance liquid chromatography. Subsequently the validation of the production process was carried out by manufacturing of lots in single-dose of the optimized injectable formulation of the radiopharmaceutical 68 Ga-DOTA-Sar gastrin and the stability study was conducted at different times to determine the useful life time. The following was established as the optimal pharmaceutical formulation: 185 MBq of 68 Ga, 50 μg de DOTA-Sar gastrin, 14 mg of sodium acetate and 0.5 m L of buffer acetates, 1.0 M, ph 4.22 in 2.5 m L of the vehicle. The analytical method used to determine the radiochemical purity of the formulation satisfied the requirements for the intended analytical application. The lots in

  8. Preliminary study fo the interference of proteic compounds of radiopharmaceuticals in the test of lisadode amebocitos de limulus (LAL)

    International Nuclear Information System (INIS)

    Aldana, Claudia

    1997-01-01

    In this thesis the objective was evaluate the interference of proteic compounds of the radiopharmaceuticals in the test LAL (lisado of amebocitos de limulus) for this, macroagregates of albumina (MAA) was used with metilendifosfonato (MDP) as control that is the radiopharmaceutical more used in the nuclear medicine centers of the country. Initially preliminary test were carried out to assess if some of two radiopharmaceuticals would cause interference with LAL test, after the test was validated and finally routine tests were made. With the preliminary assays was concluded that proteic compounds did not cause interference (albumina with a concentration of 2 md/dl) with the MAA. However with the MDP cause interference with LAL test. The interference was eliminated with a dilution of 1:8 of the sample. Was concluded that the success of LAL test depends on conditions such as temperature, pH, constant incubation (no minimum variations) and that is a good test for quality control of the radiopharmaceuticals

  9. A rapid and efficient preparation of [{sup 123}I]radiopharmaceuticals using a small HPLC Rocket[reg] column

    Energy Technology Data Exchange (ETDEWEB)

    Katsifis, Andrew [Radiopharmaceuticals Division R and D, Australian Nuclear Science and Technology, Organisation, Menai, NSW 2234, Sydney (Australia)]. E-mail: akx@ansto.gov.au; Papazian, Vahan [Radiopharmaceuticals Division R and D, Australian Nuclear Science and Technology, Organisation, Menai, NSW 2234, Sydney (Australia); Jackson, Timothy [Radiopharmaceuticals Division R and D, Australian Nuclear Science and Technology, Organisation, Menai, NSW 2234, Sydney (Australia); Loc' h, Christian [Radiopharmaceuticals Division R and D, Australian Nuclear Science and Technology, Organisation, Menai, NSW 2234, Sydney (Australia)

    2006-01-01

    A simplified method for the rapid and efficient preparation of [{sup 123}I]radiopharmaceuticals is described. Three radiopharmaceuticals, [{sup 123}I]{beta}-CIT, [{sup 123}I]MIBG and [{sup 123}I]clioquinol, were synthesised and purified as model compounds. The radiotracers were labelled with iodine-123 using electrophilic oxidative conditions and purified by a compact semi-preparative reverse phase column (C-18, 3 {mu}m, 7x53 mm, Alltima Rocket[reg, Alltech] using aqueous-ethanol as HPLC solvents that were directly used for radiopharmaceutical formulation. The radiochemical purity of the radioiodinated tracers as assessed by analytical HPLC was higher than 99% with specific activity higher than 3 GBq/nmol. The total preparation time of a radiotracer ranged from 40 to 60 min and, starting from 3.7 GBq of iodine-123, more than 2.5 GBq of formulated radiopharmaceuticals were available for clinical investigations.

  10. Joint CDRH (Center for Devices and Radiological Health) and state quality-assurance surveys in nuclear medicine: Phase 2 - radiopharmaceuticals

    International Nuclear Information System (INIS)

    Hamilton, D.R.; Evans, C.D.

    1986-08-01

    The report discusses survey results on aspects of the quality assurance of radio-pharmaceuticals from 180 nuclear-medicine facilities in the United States. Data were collected from facilities in 8 states. Demographic information about nuclear-medicine operations and quality-assurance programs was gathered by state radiation-control-program personnel. The data collected from the survey show an incomplete acceptance of quality-assurance practices for radiopharmaceuticals. Most of the facilities in the survey indicated that, because an inferior radiopharmaceutical was prepared so infrequently, they did not believe it was cost-effective to perform extensive quality-assurance testing. The Center for Devices and Radiological Health hopes that the information from the survey will stimulate nuclear-medicine professionals and their organizations to encourage appropriate testing of all radiopharmaceuticals

  11. Difficulties and aspects to take into account in the production, use and distribution of new radiopharmaceuticals PET

    International Nuclear Information System (INIS)

    Sanchez, R.; Rayo, J.I.; Serrano, J.; Infante, J.; Luz Dominguez, M.; Garcia, L.; Duran, C.

    2008-01-01

    This article seeks to describe the requirements, legal and technical, for the production, distribution and use of new radiopharmaceuticals PET (other than the 18 F.D.G.), describing the legislative framework in which we find ourselves, the characteristics of a production and types of synthesis and existing modules. A list of susceptible radiopharmaceuticals is presented that are being currently used in nuclear medicine by specifying the real possibilities of their production and use and which are the difficulties we face

  12. Results of quality control studies of technetium 99m labelled radiopharmaceuticals prepared from kits (1980-81)

    International Nuclear Information System (INIS)

    1983-01-01

    This report summarized the results of quality control studies of Tc 99m labelled human serum albumin, macroaggregated albumin, bone imaging and reticuloendothelial system imaging radiopharmaceuticals prepared from commercially available kits. It includes all analyses performed from January 1980 to December 1981 by the radiopharmaceutical quality control section of the Radiation Protection Bureau. These results were obtained by the application of various in vitro and animal (mouse) biodistribution studies

  13. Preparações radiofarmacêuticas e suas aplicações Radiopharmaceuticals and applications

    Directory of Open Access Journals (Sweden)

    Rita Oliveira

    2006-06-01

    ármacos em uso clínico corresponde a agentes de perfusão. Atualmente, o esforço de investigação na área da química radiofarmacêutica centra-se no desenvolvimento de radiofármacos específicos que possam fornecer informação, ao nível molecular, relativa às alterações bioquímicas associadas às diferentes patologias.Radiopharmaceuticals are substances without pharmacological activity that are used in Nuclear Medicine for diagnosis and therapy for several diseases. Diagnosis radiopharmaceuticals generally emit gamma radiation or positrons (beta+, because their decay originates penetrating electromagnetic radiation that can cross the tissues and be externally detected. Therapeutic radiopharmaceuticals must include in their composition ionized particles emission nucleus (a, b- or Auger electrons, since their action is based in selective tissue destruction. There are two main methods for image acquisition: SPECT (Single Photon Emission Computerized Tomography that uses g emission radionuclides (99mTc, 123I, 67Ga, 201Tl and PET (Positron Emission Tomography that uses positron emission radionuclides like 11C, 13N, 15O, 18F. Radiopharmaceuticals can be classified into perfusion radiopharmaceuticals (first generation or specific radiopharmaceuticals (second generation. Perfusion radiopharmaceuticals are transported in the blood e reach the target organ in the direct proportion of the blood stream. Specific radiopharmaceuticals contain a biologically active molecule that binds to cellular receptors that must remain biospecific after binding to the radiopharmaceutical. For this type of radiopharmaceuticals, tissue or organ uptake is determined by the biomolecule capacity of recognizing receptors in those biological structures. Radiopharmaceuticals are produced ready to use, in cold kits or in autologal preparations. According to the preparation type there is a different quality control procedure. Most of the radiopharmaceuticals used nowadays are of the perfusion type

  14. Legal aspects of the production and application of radiopharmaceuticals in Germany; Arzeinmittelrechtliche Aspekte der Herstellung und Anwendung von Radiopharmaka

    Energy Technology Data Exchange (ETDEWEB)

    Kuwert, T.; Prante, O. [Universitaetsklinikum, Erlangen (Germany). Nuklearmedizinische Klinik; Meyer, G. [Medizinische Hochschule Hannover (Germany). Klinik fuer Nuklearmedizin

    2009-06-15

    This article deals with the regulation of the production and use of radiopharmaceuticals in Germany. As in other countries, radiopharmaceuticals may be used when licensed by the German equivalent of the Federal Drug Agency or in clinical trials. Furthermore, non-licensed radiopharmaceuticals can be administered to patients for diagnosis when they are produced in the same institution and not more than 20 doses per week and radiopharmaceutical are given. A prerequisite for these three ways of use is the production of the radiopharmaceutical in question according to the guidelines of the good manufacturing practice (GMP) which creates considerable problems for the usually small PET centers installed in the German university hospitals. German law offers a further possibility to apply non-licensed radiopharmaceuticals for clinical purposes: their administration to patients is not forbidden when performed by a physician who produces the substance himself or is at least responsible for its synthesis. This regulation has, however, been met with criticism by government agencies. (orig.)

  15. Radiopharmaceutical: options to marketing authorization; Le medicament radiopharmaceutique: les alternatives a l'AMM

    Energy Technology Data Exchange (ETDEWEB)

    Guilloteau, D.; Valat, Ch. [Centre Hospitalier Regional Universitaire, Service Medecine Nucleaire In Vitro, INSERM U 619, 37 - Tours (France); Verbruggen, A. [University Hospital Gasthuisberg, Lab. of Radiopharmaceutical Chemistry, Leuven (Belgium)

    2005-04-15

    In France, since the law 92-1279 (December 1992) the tracer used in nuclear medicine are considered as medicines, and all the regulations applicable to general medicines have to be followed for radiopharmaceuticals. The best situation in order to use radiopharmaceutical in nuclear medicine center is to use a tracer with a marketing authorization. However due to the very high cost to obtain this authorization, many tracers validated by scientific community will never been sold by pharmaceutical companies. However in respect with legal rules, it is possible to prepare these tracers in the hospital radiopharmacy, under the responsibility of the radio-pharmacist. We discuss here these different possibilities (magistral preparation...) and the conditions for these preparations. (author)

  16. Eichrom's ABEC trademark resins: Alkaline radioactive waste treatment, radiopharmaceutical, and potential hydrometallurgical applications

    International Nuclear Information System (INIS)

    Bond, A.H.; Gula, M.J.; Chang, F.; Rogers, R.D.

    1997-01-01

    Eichrom's ABEC trademark resins selectivity extract certain anions from high ionic strength acidic, neutral, or strongly alkaline media, and solute stripping can be accomplished by eluting with water. ABEC resins are stable to pH extreme and radiolysis and operate in high ionic strength and/or alkaline solutions where anion-exchange is often ineffective. Potential applications of the ABEC materials include heavy metal and ReO 4 - separations in hydrometallurgy and purification of perrhenate iodide, and iodate in radiopharmaceutical production. Separation of 99m TcO 4 - from its 99 MoO 4 2- parent and stripping with water or physiological saline solution have been demonstrated for radiopharmaceutical applications. Removal of 99 TcO 4 - and 129 I - from alkaline tank wastes has also been successfully demonstrated. The authors will discuss the scale-up studies, process-scale testing, and market development of this new extraction material

  17. Preparation of gallium-68 radiopharmaceuticals for positron tomography. Progress report, November 1, 1978-October 31, 1979

    International Nuclear Information System (INIS)

    Welch, M.J.

    1978-06-01

    Although the germanium-gallium generator is probably the only source of positron-emitting radionuclides that would enable the wide application of positron tomography, the generator system in use suffers from several major disadvantages. The most important of these is that the generator is eluted with EDTA, and EDTA forms a very strong chelate with gallium. In order to produce radiopharmaceuticals other than gallium-68 EDTA it is necessary to break the stable EDTA complex and remove all the EDTA. A new generator system using a solvent extraction system which will produce gallium-68 8-hydroxyquinoline, a weak chelate has been developed. Using this agent, several gallium-68 radiopharmaceuticals have been synthesized and tested in vitro and in vivo. Attempts have been made using polarographic and chromatographic techniques to investigate the stability of gallium-68 complexes with a series of cryptates

  18. Analysis of the distribution of radiopharmaceuticals for nuclear medicine in Brazil

    International Nuclear Information System (INIS)

    Kuahara, Lilian T.; Correa, Eduardo L.; Potiens, Maria P.A.

    2013-01-01

    The objective of this study was to analyze the distribution of radiopharmaceuticals produced by Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN), as part of a project to develop a methodology for control and calibration of activimeters used by these Nuclear Medicine Services. This survey was conducted using registry data of registered customers and, with bases in such information, we analyzed the number of clinics all over the country. Considering the distribution of radiopharmaceuticals and what the most used in 2011, there was a total of 365 clinics, and this distribution as follows: Southeast with 56%, South 18%, Northeast 15%, North 4%, and Midwest with 7%. Among the various radioisotopes provided 26 were sold and most in demand are the 67 Ga, 131 I and IPEN-tec (technetium generator)

  19. Radiochemical purity and in vitro stability of Tc-99m radiopharmaceuticals

    International Nuclear Information System (INIS)

    Vucina, J.

    2001-01-01

    The increased contents of long lived 99 Tc, oxygen and cupric ions could affect the labeling yield of eight radiopharmaceuticals. Oxygen and in leaser extend copper were found to affect the radiochemical purity of the preparations. In vitro stability of radiopharmaceuticals, examined on 99m Tc(Sn)-pyrosphoshate solutions, was extended when ascorbic acid was added as the chemical stabilizer. The quantity of 5x10 -7 mol/dm 3 of ascorbic acid was found to be sufficient to keep the content of 99m Tc-pertechnetate below 1 % six hours after labeling even in the cases when 99m Tc was present in high radioactive concentrations (740-814 GBq/dm 3 ). The results led to the development of the kits in which ascorbic or gentisic acid are the standards component in the kit composition (author)

  20. Radioprotection and management of radioactive residues study in the radiopharmaceuticals laboratories

    International Nuclear Information System (INIS)

    Zidan, Priscila M.; Silva, Maria Isabel B. da

    2002-01-01

    The 123 I, used in the thyroid cancer diagnoses, is being used at several clinics of nuclear medicine, instead of 131 I. This last one, for presenting half-life 15 times bigger than the first one, causes larger doses to the patient and slower exams. Another subject is the management of the residues generated by radiopharmaceutical laboratories, which requests lager physical space, in the case of 131 I. In the present work, six radiopharmaceutical laboratories of the state of Rio de Janeiro were visited. All of them use the 131 I produced by the Nuclear Engineering Institute. In these visits radioprotection procedures and the management of residues of those laboratories were evaluated, as well as the available infrastructure