Synthesis and formulation of {sup 99m} Tc-ECD radiopharmaceutical; Sintesis y formulacion del radiofarmaco {sup 99m} Tc-ECD

Energy Technology Data Exchange (ETDEWEB)

Ocampo G, B E

1998-06-01

Nuclear medicine is a medical specialty which uses radioactive compounds (radionuclides) for diagnostic and therapeutic purposes. {sup 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 {sup 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 {sup 99m} Tc-ECD complex useful for brain perfusion imaging. We obtained a freeze dried stable formulation for the preparation of {sup 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).

Optimization of radiation protection of cell maintenance of radiopharmaceutical production; Otimizacao da radioprotecao em manutencoes de celas de producao de radiofarmacos

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Machado, Jessica S.; Gerulis, Eduardo; Todo, Alberto S.; Rodrigues Junior, Orlando, E-mail: jsmachado@ipen.b, E-mail: egerulis@ipen.b, E-mail: astodo@ipen.b, E-mail: rodrijr@ipen.b [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), SP (Brazil)

2011-10-26

This paper performs a study of maintenance tasks realized in production cells to suggest improvements related to the occupational doses based on the optimization principle of the radioprotection. A data survey has been realized of the doses received by the workers during the maintenance. The average values of effective doses are lower than the limits established in the regulations, however can be optimized

Evaluation of quality control of radiopharmaceuticals in Nuclear Medicine service; Avaliacao do controle de qualidade de radiofarmacos em servico de medicina nuclear

Energy Technology Data Exchange (ETDEWEB)

Tavares, Jamille A. Lopes; Lira, Renata F. de, E-mail: jam_alt@hotmail.com, E-mail: renatafariasdelira@hotmail.com [Universidade Federal de Pernambuco (UFPE), Recife (Brazil); Santos, Marcus Aurelio P. dos, E-mail: masantos@cnen.gov.br [Centro Regional de Ciencias Nucleares do Nordeste (CRCN-NE/CNEN-PE), Recife, PE (Brazil)

2014-07-01

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.

Dosimetric aspects of the treatment of metastatic bone pain with radiopharmaceuticals; Aspectos dosimetricos de los tratamientos del dolor oseo metastasico con radiofarmacos

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Garcia, T.; Marti, J. F.; Olivas, C.; Vercher, J. L.; Repetto, R.; Bello, P.

2014-02-01

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: {sup 3}2P, {sup 1}53Sm, {sup 1}86Re and {sup 1}88Re and the other two ones are based on high Linear energy Transference emission radionuclides: {sup 1}17mSn and {sup 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)

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

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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

Development of a pattern hot cell for production of injectable radiopharmaceuticals; Desenvolvimento de um modelo de cela para processamento de radiofarmacos injetaveis

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Campos, Fabio Eduardo de

2010-07-01

A controlled ambient should be established to the production/processing of materials susceptible to contamination, like injectable pharmaceuticals, in order to agree with normative and regulatory requirements. Considering medical but also toxic, radioactive and dangerous products, the ambient should work in special conditions to assure that the materials, which in same cases can be also volatile, do not escape to the external ambient, working in a selective, secure and controlled way. The conditions recommended by local and international rules in use, report an negative pressured ambient in relation to the adjacent areas. The technology related with the sizing of project to this kind of system is fully described in the literature, taking in account the rules that clearly describe the essential requirements. However, it is necessary to develop a controlled ambient for radiopharmaceutical production, in a way compatible with the concept of clean rooms and with the safety related to the manipulation of open radioactive wastes. In this work, some devices were created, methods and procedures were established making possible the classification of the ambient inside the hot cell, without physical barriers in the area, using ergonomic, flexible and practical conditions of work, that can results in the improvement of the productivity. The project resulted in the creation of a controlled ambient, in agreement with the normative requirements, using a pass through for entrance and exit of the materials, without compromise the internal air condition. The tight of the hot cell was obtained using doors with efficient sealing system and active joints. Tong manipulators were used to produce ergonomic and secure conditions, without compromise the internal conditions related to tight and classification in A and B grade, according to local and international rules. An efficient ventilation/exhaustion system was adopted to produce these results, composed by filters and special devices, developed exclusively to produce ideal conditions in the micro ambient. All the operational parameters of the cell were investigated by planning specific assays. The results of these assays were in agreement with the criterions established and indicated the potential of the project in the development of a hot cell for radiopharmaceutical production. (author)

Development of methodologies for internal exposure assessment due to the radiopharmaceutical 18FDG

International Nuclear Information System (INIS)

Lacerda, Isabelle Viviane Batista de

2013-01-01

The production of 18 F has increased in the last decade. It is produced basically for the synthesis of 18 F- fluorodeoxyglucose ( 18 FDG), the main radiopharmaceutical used in PET (Positron Emission Tomography) scans. The growth in the frequency of these tests resulted in rise of the number of occupationally exposed individuals (OEI) to the radionuclide 18 F as 18 FDG, increasing thereby the probability of its accidental incorporation. This study aimed to implement optimized techniques for assessing internal exposures of individuals occupationally exposed through both in vivo and in vitro bioassay methods during production and handling of 18 FDG at the Divisao de Producao de Radiofarmacos (DIPRA), Centro Regional de Ciencias Nucleares do Nordeste (CRCN-NE/CNEN). The in vivo monitoring was conducted at the Laboratorio de Dosimetria Interna, Divisao de Laboratorios Tecnico-Cientificos (DILAB). For this bioassay method, measurements were done with a 3x3' NaI(Tl) scintillation detector coupled to Genie 2000 software. The calibration of the system was performed with a brain phantom containing a standard liquid source of 22 Na to simulate a contaminated individual. The calibration of the HPGe coaxial detector for in vitro monitoring was performed at the Laboratorio de Medidas de Atividade de Radionuclideos (DIPRA/CRCN-NE/CNEN) with a standard source of 22 Na. Base on the calibration factors, it was possible to determine the minimum detectable activities (MDA) for the systems by using direct measurements and simulation of uncontaminated urine. Then, through the biokinetic models published by ICRP 106 and edited by the AIDE software (version 6.0), it was possible to estimate the minimum detectable effective dose (MDED), which evaluates the detection sensitivity of the techniques developed. The MDED was estimated for in vivo and in vitro measurements performed 2.4 hours after the occurrence of incorporation by ingestion, since this is the period of higher retention fraction

Radiation protection optimization in practices for radiopharmaceuticals production at IEN; Otimizacao da protecao radiologica nas praticas para a producao de radiofarmaco no IEN

Energy Technology Data Exchange (ETDEWEB)

Santos, Osvaldir Paulo dos

2004-06-15

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)

Development of aptamers for use as radiopharmaceuticals in the bacterial infection identification; Desenvolvimento de aptameros especificos para aplicacao como radiofarmacos na identificacao de bacterias

Energy Technology Data Exchange (ETDEWEB)

Ferreira, Ieda Mendes

2013-08-01

The difficulty in early detection of specific foci caused by bacteria in the bacterial infection has raised the need to search for new techniques for this purpose, since these foci require prolonged treatment with antibiotics and in some cases even drainage or, if applicable, removal of prostheses or grafts. Detection of bacterial infections by scintigraphy had the advantage that a whole body image could be obtained, since specific tracers were available. This study aims to obtain aptamers specific for bacteria identification for future use as radiopharmaceutical. The SELEX (Systematic Evolution of Ligands by Exponential Enrichment) methodology can generate oligonucleotides (aptamers) that are able to bind with high affinity and specificity to a specific target, from small molecules to complex proteins, by using rounds of enrichment and amplification. Aptamers can be labeled with different radionucleotides such as {sup 99}mTc, {sup 18}F and {sup 32}P. In this study, aptamers anti-peptidoglycan, the main component of the bacterial outer cell wall, were obtained through SELEX. Whole cells of Staphylococcus aureus were also used to perform the SELEX to cells (cell-SELEX). The selection of aptamers was performed by two different procedures (A and B). The A process has been accomplished by 15 SELEX rounds in which the separation of the oligonucleotides bound to the peptidoglycan of unbound ones was performed by filtration. In the B process 15 SELEX rounds were performed using the centrifugation for this separation, followed by 5 rounds cell-SELEX. The SELEX started with a pool of ssDNA (single stranded DNA). For A process, initially a library of ssDNA was incubated with peptidoglycan and the amplification of oligonucleotides that were able to bind to peptidoglycan was performed by PCR (Polymerase Chain Reation). The amplified oligonucleotides were again incubated with peptidoglycan, amplified and purified. At the end of 15 selection rounds the selected oligonucleotides were cloned. The product of recombination was used to transform Escherichia coli ToplOF'. The plasmid DNA from 40 selected colonies were extracted and quantified. The plasmids were sequenced, two different sequences (Antibac1 and Antibac2) were obtained and their secondary structures determined. The aptamers obtained were synthesized and labeled with {sup 32}p. The labeled aptamers were incubated with S. aureus cells and the amount of radiolabeled ssDNA was determined by liquid scintillation spectrometry. The oligonucleotides library labeled with {sup 32}p was used as control. For the aptamer Antibac1 the radiation linked to the pellet was 28 times higher than obtained with the control and for the Antibac2 was 22 higher. A specific assay was conducted with labeled aptamers using S. aureus, E. co ti, Candida albicans and human fibroblasts. For both aptamers (Antibac1 and Antibac2) binding to bacterial cells was significantly higher than for C. albicans and fibroblasts, demonstrating their specificity for bacteria. For B process, after 15 SELEX rounds was performed the cell-SELEX starting with the products 15th round being incubated with S. aureus cells. The amplified oligonucleotides were incubated again with the bacteria in the next round and so on. At the end of the 5 rounds of selection, the selected oligonucleotides were cloned and sequenced as in A process. Eleven different sequences from 21 clones were obtained and their secondary structures were determined. The aptamers obtained by process A showed high affinity and specificity for bacteria. The aptamers obtained by process B will be evaluated for these parameters in a future work. (author)

Preparation and stability of the {sup 99m} Tc-HNE{sub 2} radiopharmaceutical; Preparacion y estabilidad del radiofarmaco {sup 99m} TC-HNE{sub 2}

Energy Technology Data Exchange (ETDEWEB)

Estrada T, J

2002-07-01

A radiopharmaceutical is all substance containing a radioactive atom inside of its structure and what because of its pharmaceutical form, quantity and quality of radiation can be administered in the human beings with diagnostic or therapeutic aims. With the purpose to developing effective radiopharmaceuticals it is necessary to pick carefully the appropriate radionuclide in combination with the In vivo localization and the pharmacon kinetic properties of the carrier molecule. The peptides are designed by the nature to stimulate, regulate or inhibit numerous life functions, they act mainly as information transmitters and activity coordinators of several tissues in the body; it has been found that such substances are present in cells and in the body fluids in quantities extremely small, therefore the peptides have been considered as ideal agents for therapeutic applications. Elastase of human neutrophylls is a 29 kDa protease which is produced in high levels inside the neutrophyll and it is released as response for an inflammatory stimulus in infection/inflammation places. Once it liberated is quickly inhibited by the anti elastase {alpha} tripsine (HNE-2) peptide. Therefore, the neutrophylls elastase is considered as a target to obtain In vivo images of inflammatory/infectious processes by the intravenous application of {sup 99m} Tc-HNE-2. The objective of this work was to develop a labelling method with {sup 99m} Tc for the inhibitor peptide of the human neutrophyll elastase (HNE-2). Likewise, for evaluating its In vivo and In vitro stabilities. The methodology which was followed as first step to conjugate the (HNE-2) peptide with the bi chelating agents HYNIC and DTPA capable to chelate the {sup 99m} Tc metal. Therefore the attachment reactions to the peptide were realized starting from the NHS and HYNIC and the DTPA anhydride in buffer of 0.1 M, pH= 9.0/DMF (10:1) bicarbonates with a molar relation peptide/bi chelating agent 1:5. For the purification of the conjugate the solid phase extraction was used, using the C-18 sep-pak cartridges. The native peptide and the conjugate were characterized by High Performance Liquid Chromatography (HPLC) using a molecular exclusion column for YMC-Pack Diol-60 peptides, phosphates buffer 0.1 M p H= 7.4 at a flux 1.5 ml/min; integrated to a diode arrangement detector to obtain the UV spectra and a radioactivity detector for obtaining the radio chromatograms of the compounds in study, verifying that the different bifunctional agents will be separate appropriately from the peptide, once formed the conjugate peptide, the labelling with {sup 99m} Tc was realized using sodium pertechnetates (NaTcO{sub 4}) eluted from a {sup 99}Mo/{sup 99m} Tc generator and as a reducer agent stannous chloride. The In vitro stability tests were realized measuring the radiochemical purity of the radio peptide in Instant Thin Layer Chromatography with silica-gel (ITLC-SG), NaCl 0.9% and acetone as eluent systems at different time intervals in solutions of different cysteine concentration. These tests indicated the trans chelation grade of the {sup 99m} Tc metal. In the In vivo evaluations the stability of the {sup 99m} Tc-HNE-2 was obtained when it was realized the biodistribution in normal mice of the balb-c stock. The obtained results show a radiochemical purity of 95.05 % {+-} 2.81% for the {sup 99m} Tc-DTPA-HNE-2 conjugates and 51.45% {+-} 3.2% for {sup 99m} Tc-HYNIC-HNE-2 even as tricine as colligand was used. The In vivo and In vitro stability tests of the radio conjugates show that the radio complexes are keeping whole at least during 24 hours (In vitro) time in which passing for half life of the {sup 99m} Tc radionuclide and 30 min (In vivo). Since the radio conjugates prepared with DTPA were obtained with radiochemical purities adequate for its use in scintillography, it is necessary as a future work to realize the biodistribution kinetics as in healthy animals as in models with induced infectious processes. Likewise for obtaining gamma graphic images at different times, from animals with induced infections, with the purpose to determine the radiopharmaceutical effectiveness for detecting infectious centres. (Author)

Preparation of the radiopharmaceutical {sup 99m} Tc-HYNIC-[Lys{sup 3}]-BN; Preparacion del radiofarmaco {sup 99m} Tc-HYNIC-[Lys{sup 3}]-BN

Energy Technology Data Exchange (ETDEWEB)

Conde S, E [Universidad Autonoma del Estado de Mexico, Facultad de Quimica, 50000 Toluca, Estado de Mexico (Mexico)

2007-07-01

In accordance with their design, the radiopharmaceuticals can be divided in three generations. The radiopharmaceuticals of third generation are used in nuclear medicine to obtain images of specific molecular targets, and they are only in their capacity to detect in vivo such specific biochemical places as receivers and enzymes. The receivers of regulator peptides are over expressed in numerous carcinogenic cells. Those receivers have been used as molecular targets of radiolabelled peptides to locate cancerous tumors. The small peptide bombesin (BN, 14 amino acids) it was isolated of the frog skin and it belongs to a wide neuropeptides group with many biological functions. The equivalent human is the liberator peptide of the gastrin (GRP, 27 amino acids) and his receivers (r-GRP) that are on expressed in the membranes of the tumor cells. The receiving subtype 2 of bombesin (receiving GRP) it is on expressed in several human tumors including breast, prostate, lung cells and pancreatic cancer. Some radiopharmaceuticals similar of BN has been developed that were prepared to be used in nuclear medicine for the detection of wicked tumors and to evidence prostate cancers, breast and of lymphatic nodules. A technique was developed to allow the conjugation of HYNIC-[Lys3]-BN that allowed to obtain this product with a high purity. The identity was determined by HPLC chromatography. It was necessary the validation of the method and the HPLC system, to assure that the results were reliable. Linearity, specificity, accuracy and precision parameters were analyzed, that are those required by the Mexican pharmacopoeia for chromatographic methods. With this conjugated a formulation for lyophilized kits were analyzed, with the purpose of obtaining a radiochemical purity, after the labelled one with {sup 99m}Tc, bigger to 95%; the components used in the nucleus-equipment should favor the conjugation of the {sup 99m}Tc by means of a ligands exchange between the tricine and the hydrazinenicotinamidic acid (HYNIC). The formulation that was obtained for the scaling of the lots is shown in the following relationship among reagent and quantity: HYNIC-[Lys{sup 3}]-BN (HYNIC-Bombesin), 25 {mu}g; tin chloride, 10 mg; Ethylenediamineacetic acid (EDDA), 10 mg; N-tris(hydroxymethyl)methylglycine (Tricine), 20 mg; Manitol, 50 mg. The radiochemical purity was determined by means of HPLC coupled to a radioactivity detector. The stability tests demonstrate that the one conjugated is stable until for three months; also, the activity stays for more than 24 hours, that which makes very versatile the use of the nucleus-equipment in the clinical area. The incorporation of radioactivity in the pancreas demonstrated the ability of the radiopharmaceutical to unite In vivo to cells related with GRP receivers. Also, the studies of blockade of receivers confirmed the specificity of the bio conjugated by the GRP-r. The incorporation inside the PC-3 cells receiver-positive it went significantly smaller to that of the pancreas, but the incorporation to the tumor was highly specific. (Author)

Kinetic and allometric models for dosimetry using radiopharmaceuticals labeled with lanthanides; Proposicao de modelos cineticos e alometricos para a dosimetria de radiofarmacos marcados com lantanideos

Energy Technology Data Exchange (ETDEWEB)

Lima, Marina Ferreira

2012-07-01

This work proposes two models based in compartmental analyses: Animal model and Human model, using images from gamma camera measurements to determinate the kinetic constants of the {sup 177}Lu-DOTATATE to three animal species (rat Wistar, Armenian hamster and Syrian hamster) and to the human in biodistribution studies split in two phases: Phase 1 governed by uptake from the blood and Phase 2 governed by the real excretion. The kinetic constants obtained from the animals' data ere used to build allometric scaling to predict radiopharmaceutical biodistribution in the human employing relations by mass, metabolism, by life span and by physiological parameters. These extrapolation results were compared with the PRRT (Peptide receptor radiotherapy) patients kinetic data calculated using the Human model. The kinetic constants obtained from humans were used in dose assessment to PRRT patients considering MIRD 26 organs and tissues. Dosimetry results were in agreement with available results from literature. For the Phase 1 allometric scaling from kinetic data from the blood to the organs straight responsible for the {sup 177}Lu-DOTATATE metabolism and excretion - liver, kidneys and urinary bladder -show good correlation in the scaling by mass, metabolism and physiological and parameters. For the Phase 2, only the kinetic data from blood to the liver and to the kidneys show good correlation. Based in the anaesthetics inhibitory action over the renal excretion, there is not empirical basis to allow measurement times over 40 minutes in in vivo studies with small animals. Consequently, the Phase 1 results seem enough to make allometric scaling to assessment dose in PRRT. (author)

Control flow of radiopharmaceuticals in nuclear medicine by means of an E-service; Control flujo de radiofarmacos en medicine nuclear por medio de un E-servicio

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Nunez Martin, L.; Gonzalez de Mingo, M. A.; Fragua Redondo, J. A.; Martinez Ortega, J.; Gutierrez Camunas, S.; Redondo Miguel, A. B.

2013-07-01

The almost generalized use of single-dose Nuclear Medicine for performing diagnostic tests or treatments, and the consequent complexity that accompanies its management, has resulted in the need to control the flow of material radioisotopic tools. An e-service is designed to manage the flow of radiopharmaceuticals and control its use and spending. This control does not only affect the efficiency in the use and cost of material, but in the radioactive waste associated with the non-use and waste reduction and a more effective organization of the Department. (Author)

Determination of Sn in 99{sup m}Tc Radiopharmaceutical Kits by Polarographic Methods; Determinacion de Estano en Radiofarmacos de 99{sup m}Tc mediante Metodos Polarograficos

Energy Technology Data Exchange (ETDEWEB)

Castro, M; Cruz, J; Sanchez, M

2009-07-01

Kits of 99{sup 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{sup m}Tc-pertechnetate in cold kits for on-site preparation 99{sup 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.

Radiopharmaceuticals: nanoparticles like multi-functional systems for the obtaining in vivo of molecular images; Radiofarmacos: nanoparticulas como sistemas multifuncionales para la obtencion in vivo de imagenes moleculares

Energy Technology Data Exchange (ETDEWEB)

Ferro F, G.; Ramirez de la Cruz, F. M.; Ocampo G, B. E.; Morales A, E.; Santos C, C. L.; Mendoza S, A. N., E-mail: guillermina.ferro@inin.gob.m [ININ, Departamento de Materiales Radiactivos, Carretera Mexico-Toluca s/n, 52750 Ocoyoacac, Estado de Mexico (Mexico)

2010-07-01

The techniques of obtaining direct or indirect molecular images detect and register the space-temporary distribution of molecular or cellular processes for biochemical, biological, diagnostic and therapeutic applications. The advanced techniques of image like the nuclear magnetic resonance, the single photon emission computed tomography, the positron emission tomography and the images of optic fluorescence have been used successfully to detect these processes. On the other hand, the utility of the nanoparticles for any application is dependent of the physicochemical properties that present, being possible to modify their surface when making them react with different biomolecules what allows the formation of conjugates with specific molecular recognition. The joint of various protein molecules, peptides or oligonucleotides to the surface of a nanoparticle produce a multi-functional system able to increase the multivalent joints from the nanoparticles-biomolecules to their receivers for the obtaining of molecular images in vivo. The peptides stimulate, regulate or inhibit numerous functions of the life, acting mainly as information transmitters and activity coordinators of several tissues in the organism. The receivers of regulator peptides are over represented in numerous types of cancer cells and they are protein structures. These receivers have been used as white molecular of marked peptides, to locate primary malignant tumors and their metastasis, using the diagnostic techniques of molecular image mentioned above, which consist basically on the radio peptides use and conjugated peptides to fluoro chromes, to metallic nanoparticles and nano crystals. A summary of the work is presented carried out by the personnel of the Radio-active Materials and Chemistry Departments of the Instituto Nacional de Investigaciones Nucleares in this field. (Author)

Determination of bacterial endotoxin (pyrogen) in radiopharmaceuticals by the gel clot method. Validation; Determinacao de endotoxina bacteriana (pirogenio) em radiofarmacos pelo metodo de formacao de gel. Validacao

Energy Technology Data Exchange (ETDEWEB)

Fukumori, Neuza Taeko Okasaki

2008-07-01

Before the Limulus amebocyte lysate (LAL) test, the only available means of pirogenicity testing for parenteral drugs and medical devices was the United States Pharmacopoeia (USP) rabbit pyrogen test. Especially for radiopharmaceuticals, the LAL assay is the elective way to determine bacterial endotoxin. The aim of this work was to validate the gel clot method for some radiopharmaceuticals without measurable interference. The FDA's LALTest guideline defines interference as a condition that causes a significant difference between the endpoints of a positive water control and positive product control series using a standard endotoxin. Experiments were performed in accordance to the USP bacterial endotoxins test in the {sup 131}I- m-iodobenzylguanidine; the radioisotopes Gallium-67 and Thallium-201; the lyophilized reagents DTPA, Phytate, GHA, HSA and Colloidal Tin. The Maximum Valid Dilution (MVD) was calculated for each product based upon the clinical dose of the material and a twofold serial dilution below the MVD was performed in duplicate to detect interferences. The labeled sensitivity of the used LAL reagent was 0.125 EU mL{sup -1} (Endotoxin Units per milliliter). For validation, a dilution series was performed, a twofold dilution of control standard endotoxin (CSE) from 0.5 to 0.03 EU mL{sup -1}, to confirm the labeled sensitivity of the LAL reagent being tested in sterile and non pyrogenic water, in quadruplicate. The same dilution series was performed with the CSE and the product in the 1:100 dilution factor, in three consecutive batches of each radiopharmaceutical. The products {sup 131}I-m-iodobenzylguanidine, Gallium-67, Thallium-201, DTPA, HSA and Colloidal Tin were found compatible with the LAL test at a 1:100 dilution factor. Phytate and GHA showed some interference in the gel clot test. Other techniques to determine endotoxins as the chromogenic (color development) and the turbidimetric test (turbidity development), were also assessed to get valuable quantitative and qualitative information about the endotoxin concentration in samples. (author)

Determination of bacterial endotoxin (pyrogen) in radiopharmaceuticals by the gel clot method. Validation; Determinacao de endotoxina bacteriana (pirogenio) em radiofarmacos pelo metodo de formacao de gel. Validacao

Energy Technology Data Exchange (ETDEWEB)

Fukumori, Neuza Taeko Okasaki

2008-07-01

Before the Limulus amebocyte lysate (LAL) test, the only available means of pirogenicity testing for parenteral drugs and medical devices was the United States Pharmacopoeia (USP) rabbit pyrogen test. Especially for radiopharmaceuticals, the LAL assay is the elective way to determine bacterial endotoxin. The aim of this work was to validate the gel clot method for some radiopharmaceuticals without measurable interference. The FDA's LALTest guideline defines interference as a condition that causes a significant difference between the endpoints of a positive water control and positive product control series using a standard endotoxin. Experiments were performed in accordance to the USP bacterial endotoxins test in the {sup 131}I- m-iodobenzylguanidine; the radioisotopes Gallium-67 and Thallium-201; the lyophilized reagents DTPA, Phytate, GHA, HSA and Colloidal Tin. The Maximum Valid Dilution (MVD) was calculated for each product based upon the clinical dose of the material and a twofold serial dilution below the MVD was performed in duplicate to detect interferences. The labeled sensitivity of the used LAL reagent was 0.125 EU mL{sup -1} (Endotoxin Units per milliliter). For validation, a dilution series was performed, a twofold dilution of control standard endotoxin (CSE) from 0.5 to 0.03 EU mL{sup -1}, to confirm the labeled sensitivity of the LAL reagent being tested in sterile and non pyrogenic water, in quadruplicate. The same dilution series was performed with the CSE and the product in the 1:100 dilution factor, in three consecutive batches of each radiopharmaceutical. The products {sup 131}I-m-iodobenzylguanidine, Gallium-67, Thallium-201, DTPA, HSA and Colloidal Tin were found compatible with the LAL test at a 1:100 dilution factor. Phytate and GHA showed some interference in the gel clot test. Other techniques to determine endotoxins as the chromogenic (color development) and the turbidimetric test (turbidity development), were also assessed to get valuable quantitative and qualitative information about the endotoxin concentration in samples. (author)

Quality assessment of radiopharmaceuticals in nuclear medicine services at Northeast states, Brazil; Avaliacao da qualidade de radiofarmacos em servicos de medicina nuclear de estados da regiao nordeste

Energy Technology Data Exchange (ETDEWEB)

Andrade, Wellington Gomes de

2012-07-01

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{sup 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 {sup 99M}o-{sup 99m}Tc eluate and radiopharmaceuticals labeled with {sup 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)

Development of a methodology for radionuclide impurity analysis in radiopharmaceuticals using gamma spectrometry; Desenvolvimento de uma metodologia para analise de impurezas radionuclidicas em radiofarmacos por espectrometria gama

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Paula, Eduardo Bonfim de; Araujo, Miriam Taina Ferreira de; Delgado, Jose Ubiratan; Poledna, Roberto; Lins, Ronaldo; Leiras, Anderson; Silva, Carlos Jose da; Oliveira, Antonio Eduardo de, E-mail: bonfim@bolsista.ird.gov.br, E-mail: miriamtaina@hotmail.com [Instituto de Radioprotecao e Dosimetria (IRD/CNEN-RJ), Rio de Janeiro, RJ (Brazil)

2016-07-01

The LNMRI has sought to develop a methodology for the identification and accurate detection of gamma radiation impurities stations in metrological level, aiming to meet the recommendations not only of international pharmacopoeia, as well as the CNEN and ANVISA regarding the quality control can ensure patients the doses received by the practices are as low as feasible. As an initial target, it was possible to obtain an efficiency curve with uncertainty around 1% necessary to initiate future measurements of interest applied to nuclear medicine and to start the development of impurities analysis technique. (author)

Quality assessment of radiopharmaceuticals in nuclear medicine services at Northeast states, Brazil; Avaliacao da qualidade de radiofarmacos em servicos de medicina nuclear de estados da regiao nordeste

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Andrade, Wellington Gomes de

2012-07-01

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{sup 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 {sup 99M}o-{sup 99m}Tc eluate and radiopharmaceuticals labeled with {sup 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)

Radiological investigation in the outside area of expedition's room during radiopharmaceuticals' expedition; Avaliacao radiologica na area externa da sala de expedicao durante a expedicao de radiofarmacos

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Reina, Luiz C.; Monteiro, Ilka H.T.S.; Silva, Joao Carlos P. da; Teixeira, Danilo L.; Pedro, C.R.; Santos, J. Regis dos, E-mail: reina@ien.gov.br, E-mail: jcarlos@ien.gov.br [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de janeiro, RJ (Brazil)

2013-07-01

Radiopharmaceuticals produced in IEN - Instituto de Engenharia Nuclear of the Brazilian Nuclear Energy Commission, are issued by the radiation protection team, which is responsible for preparing and issuing the packaged documentation required for movement in modal transportation. The documents are: Invoice , Shipper's Declaration of Radioactive Material , Shipper's Declaration of Dangerous Goods - (form IATA ) , Emergency Sheet, sketch of packed. All this documentation is inserted in an envelope of emergency. The Department of Radiological Protection is responsible for issuing such documents except the invoice that is issued by the Commercial Sector (Setcom). A employee of this sector is responsible for delivering it to the shipment sector. The preparation of packaged and documentation is performed in a room located in the building of Radiopharmaceutical Division. The vehicles which are used in the transport are parked outside this building, where are monitored after commissioning of packaged. The present study aims to evaluate potential and occupational radiation risks of people in transit or remain in the area where radioactive material circulates due to the shipment of radiopharmaceuticals for the classification of the area during the operation of dispatch.

Preparation of the radiopharmaceutical {sup 131}I-Anti-CD20 for the treatment of lymphomas; Preparacion del radiofarmaco {sup 131}I-Anti-CD20 para el tratamiento de linfomas

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Pantoja H, I E

2004-07-01

At the present time they are considered to the lymphomas like a problem of first magnitude since has happened it is necessary to be the fifth cancer cause in the world. Different treatments focused to the lymphoma like the chemotherapy and the radiotherapy, have been employees to counteract the No-Hodgkin lymphoma, without these they don't exclude the healthy tissue of the toxicity. It is for it that is taking a new direction with the employment of the directed radioimmunotherapy since this it allows to kill wicked cells selectively with radiation dose joined to the apoptosis and cytotoxicity induced by the own one bio molecule. The radioimmunotherapy with radiolabelled antibodies directed to the surface antigen CD20 represents a new modality for the treatment of No-Hodgkin lymphoma and potentially other illnesses. In this work the parameters of optimization are presented for the preparation, control of quality and evaluation of the stability in vitro and in vivo of the monoclonal antibody anti-CD20 labelled with {sup 131} I for the treatment of No-Hodgkin lymphoma. The anti-CD20 labelled by the chloramine-T method with high radiochemical purity (>98%), it is stable in solution for but of a half life of the radionuclide (8.04 days) The {sup 131} I-anti-CD20 doesn't present dehalogenation in vitro (human serum) during 24 h of incubation at 37 C. According to the tests carried out to establish the immunoreactivity, a percentage of union to cells was obtained (B lymphocytes) bigger to 30%. The biodistribution in mice balb/c one hour after their administration, it shows that there is not high reception in mucous neither kidneys, what indicates that the complex is stable in vivo. In conclusion, the radiopharmaceutical {sup 131} I-anti-CD20 was obtained in sterile injectable solution and free of pyrogens with a radiochemical purity bigger to 98% and a specific activity of 296 MBq. The radiolabelled molecule maintains its biological recognition for the receiving CD20 highly expressed in the cells of No-Hodgkin lymphomas. (Author)

Preparation of the radiopharmaceutical {sup 131}I-Anti-CD20 for the treatment of lymphomas; Preparacion del radiofarmaco {sup 131}I-Anti-CD20 para el tratamiento de linfomas

Energy Technology Data Exchange (ETDEWEB)

Pantoja H, I.E

2004-07-01

At the present time they are considered to the lymphomas like a problem of first magnitude since has happened it is necessary to be the fifth cancer cause in the world. Different treatments focused to the lymphoma like the chemotherapy and the radiotherapy, have been employees to counteract the No-Hodgkin lymphoma, without these they don't exclude the healthy tissue of the toxicity. It is for it that is taking a new direction with the employment of the directed radioimmunotherapy since this it allows to kill wicked cells selectively with radiation dose joined to the apoptosis and cytotoxicity induced by the own one bio molecule. The radioimmunotherapy with radiolabelled antibodies directed to the surface antigen CD20 represents a new modality for the treatment of No-Hodgkin lymphoma and potentially other illnesses. In this work the parameters of optimization are presented for the preparation, control of quality and evaluation of the stability in vitro and in vivo of the monoclonal antibody anti-CD20 labelled with {sup 131} I for the treatment of No-Hodgkin lymphoma. The anti-CD20 labelled by the chloramine-T method with high radiochemical purity (>98%), it is stable in solution for but of a half life of the radionuclide (8.04 days) The {sup 131} I-anti-CD20 doesn't present dehalogenation in vitro (human serum) during 24 h of incubation at 37 C. According to the tests carried out to establish the immunoreactivity, a percentage of union to cells was obtained (B lymphocytes) bigger to 30%. The biodistribution in mice balb/c one hour after their administration, it shows that there is not high reception in mucous neither kidneys, what indicates that the complex is stable in vivo. In conclusion, the radiopharmaceutical {sup 131} I-anti-CD20 was obtained in sterile injectable solution and free of pyrogens with a radiochemical purity bigger to 98% and a specific activity of 296 MBq. The radiolabelled molecule maintains its biological recognition for the receiving CD20 highly expressed in the cells of No-Hodgkin lymphomas. (Author)

Methodology for implementation of a national metrology net of radionuclides used in nuclear medicine; Metodologia para a implementacao de uma rede de referencia para metrologia de radiofarmacos no Brasil

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Santos, Joyra Amaral dos

2004-01-15

The National Laboratory for Ionizing Radiation Metrology, of the Institute of Radiation Protection and Dosimetry, of the National Commission on Nuclear Energy (IRD/CNEN), comes leading a comparison program for activity measurements of radiopharmaceuticals administered to patients in the Nuclear Medicine Services (NMS) with the purpose to promote the quality control. This work presents a quality assurance program for the performance of such measurements, evaluated in the comparison runs between hospitals and LNMRI, under the statistic point of view and the compliment of regulatory authority norms. The performance of the radionuclides {sup 67}Ga, {sup 123}I, {sup 131}I,{sup 99m}Tc and {sup 210}Tl were evaluated and {sup 201}TI have been standardized by absolute methods. Besides, it was established the traceability of the radioactivity standards used in nuclear medicine and a methodology for implementation of a national metrology net of radionuclides. The comparison results prove that the implementation of a radionuclide metrology net is viable, important and feasible. (author)

Determination of radiochemistry purity and pH of radiopharmaceutical in Northeast nuclear medicine services; Determinacao da pureza radioquimica e pH de radiofarmacos em servicos de medicina nuclear do Nordeste

Energy Technology Data Exchange (ETDEWEB)

Andrade, Wellington; Santos, Poliane, E-mail: wellington.gandrade@gmail.com, E-mail: polianeangelo@gmail.com [Universidade Federal de Pernambuco (UFPE), Recife, PE (Brazil); Lima, Fernando de Andrade; Lima, Fabiana Farias de, E-mail: falima@cnen.gov.br, E-mail: ffmima@cnen.gov.br [Centro Regional de Ciencias Nucleares do Nordeste (CRCN-NE/CNEN-PE), Recife, PE (Brazil)

2013-07-01

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 {sup 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 Registered-Sign 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 Registered-Sign ) 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)

Experiences in the transport of radiopharmaceuticals and labelled compounds in the last decade in Cuba; Experiencias en el transporte de radiofarmacos y compuestos marcados en el ultimo decenio en Cuba

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Amador B, Z.H.; Perez P, S.; Ayra P, F.E.; Torres B, M.B. [Centro de Isotopos, Ave. Monumental y Carretera La Rada, Km 3, Guanabacoa, Apartado 3415, Ciudad de La Habana, (Cuba)]. e-mail: dsr@centis.edu.cu

2006-07-01

The Center of Isotopes (CENTIS) it is the main transport entity of radioactive materials of the Republic of Cuba in whose activity almost accumulates a decade. Its are executed the design, the production, the maintenance and/or repair of the packings, as well as the preparation, remission, charges, transporting (including the in traffic storage), it discharges and reception in the final destination, of the remittances. Presently work the results of the implementation of the radiological safety and quality assurance programs developed for the safe transport of radioactive bulks and the experiences in the design and essay of bulks type A are shown. The postulated radiological events are evaluated. Three courses of 10 school hours each one, they are imparted, with theoretical and practical exams. The maximum, minimum and average values of the annual effective doses of the workers and the collective doses per year are reported, for the period 1996-2005. It is guaranteed the administrative control and the traceability of the bundles. (Author)

Comparison study among methodologies of planar chromatography for radiochemical control of technetium-99m; Estudo comparativo entre metodologias de cromatografia planar para controle radioquimico de radiofarmacos de tecnecio-99m

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Monteiro, Elisiane de Godoy

2012-07-01

Radiopharmaceuticals are substances that have radioisotopes in their composition. About 95% of the procedures performed in nuclear medicine use radiopharmaceuticals with diagnostic purposes, and the Lyophilized Reagents (LR) labeled with Technetium-99m ({sup 99}mTc), obtained from {sup 99}Mo/{sup 99}mTc generator, are the most one used. Quality Control represents the set of assays to be performed to assure that the product is adequate to its purpose. An important feature to be evaluated in {sup 99m}Tc radiopharmaceuticals is the radiochemical purity (% RqP) to quantify free pertechnetate ({sup 99}mTcO{sub 4}{sup -}) and technetium colloidal (99mTcO{sub 2}) mainly by paper chromatography (PC), thin layer (TLC) and High Performance Liquid Chromatography (HPLC). The objective of this work was to perform the comparison among the radiochemical control methodologies of LR labeled with {sup 99m}Tc, described in the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) and those used by IPEN. {sup 99m}TcO{sub 4}{sup -} eluate and DISIDA, DMSA, DTPA, EC, ECD, GHA, MIBI, MDP, PIRO, SAH and Sn Coloidal LR were provided by IPEN-CNEN/SP. TLC-cellulose, TLC-SG.TLC-SG reverse phase, HPTLC-cellulose, HPTLC-SG (Merck) and ITLC-SG (Pall Corporation), W1MM, W3MM, W17M e W31ET (Whatman) chromatographic plates were used. The measurement of the radioactivity was done in a Perkin Elmer Cobra D-5002 gamma counter. LR were labeled to obtain 55,0 MBq mL{sup 1} (1,5 mCi mL{sup 1}) of final radioactive concentration. The %{sup 99m}TcO{sub 4}{sup -}, %{sup 99m}TcO{sub 2} and % RqP were determined up to 4 hour labeling. From 11 LR, only EC and GHA have no radiochemical control methods in USP and EP. In USP and/or EP, DTPA, MDP, PIRO, SAH and Sn Coloidal methods use ITLC-SG; IPEN uses this chromatography plate in DISIDA, EC, ECD, GHA, PIRO, MIBI and SAH. As ITLC-SG had been out of production (recommended in 40, 70 and 41% of the USP, EP and IPEN methodologies, respectively), it was necessary to search alternatives to replace ITLC-SG plate in the radiochemical control, comparing with HPTLC (cellulose and silica gel) and Whatman plates (with thickness and flow rate differences). The % RqP results determined by the methods described in USP, EP, IPEN and the methods evaluated in this work presented coefficient of variation less than 5%, and it was not considered a significant value among the methods. Some chromatographic systems evaluated in this work can be used as replacement to the ITLC-SG plate. HPTLC-cellulose was the plate that presented time of analysis chromatography profile and cost similar to ITLC-SG, making it one of the most indicated to replace ITLC-SG, in 11 LR evaluated. (author)

Development of a therapeutic radiopharmaceutical {sup 177}Lu-DOTA- Minigastrin for potential use in PRRT; Desarrollo de un radiofarmaco terapeutico {sup 177}Lu-DOTA-Minigastrina para su potencial uso en PRRT

Energy Technology Data Exchange (ETDEWEB)

Lopez Bularte, A. C.; Nevares, N. N.; Zapata, A. M.; Perez, J. H.; Crudo, J. L. [Comision Nacional de Energia Atomica (Argentina); Puerta Yepes, N.; Rojo, A. M. [Autoridad Regulatoria Nuclear (Argentina)

2010-07-01

The aim of this work is to obtain {sup 177}Lu-DOTA-Minigastrin with high radiochemical purity (RP) and the highest specific activity (Ae) as possible, using a locally produced (Nuclear Reactor RA-3, Ezeiza Atomic Center) {sup 177}LuCl{sub 3} of an intermediate level of Ae (between 6.36 to 17.95 Ci/mg of {sup 176}Lu) ) and also to perform in vitro and in vivo stability tests, dose calculation in normal mice and its extrapolation to a human model. (authors) [Spanish] El objetivo de este trabajo consistio en obtener {sup 177}Lu-DOTA-Minigastrina con una alta pureza radioquimica (PR) y la mayor actividad especifica (Ae) posible, empleando {sup 177}LuCl{sub 3} de media Ae (entre 6,36-17,95 Ci/mg de {sup 176}Lu) de produccion local (Reactor Nuclear RA-3, Centro Atomico Ezeiza), y realizar los ensayos de estabilidad in vitro e in vivo, el calculo de dosis en ratones normales y su extrapolacion a un modelo humano. (autores)

Study of the radioactive impurities gamma emitters present in the radiopharmaceutical solutions produced at IPEN/CNEN-SP; Estudo das impurezas radioativas gama emissoras presentes nos radiofarmacos produzidos no IPEN-CNEN/SP

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Almeida, Jamille da Silveira

2017-11-01

This work aims to investigate the concentration of radioactive impurities gamma emitters in the radiopharmaceutical solutions produced at Nuclear and Energy Research Institute -IPEN in Sao Paulo, So that this radiopharmaceutical may be used properly, its quality should be evaluated in accordance with the procedures established by quality control agencies, such as General Requirements for the Competence of Testing and Calibration Laboratories' ISO/IEC 17025:2005 and the 'Good Laboratory Practice (GLP), controlled by ANVISA (National Agency Health Surveillance), in Brazil, requiring a confirmation of the values of impurities related at the certificates supplied by the manufacturers. To determine the activity, a high resolution gamma spectrometer were used in two source-detector distances. One was 18 cm and the other 1.7 cm. For the 18 cm distance, the high pure germanium spectrometer was calibrated in the energy range between 81 keV and 1408 keV by measuring sealed ampoules of {sup 60}Co, {sup 133}Ba, {sup 137}Cs and {sup 152}Eu, standardized at the Nuclear Metrology Laboratory (NML) of IPEN. For lower activity of the impurities, the distance source-detector of 1.7 cm was assumed. However, as at this distance, the sum coincidence effect is very high, making the measurement of the standard calibration ampoules difficult, the spectrometer efficiency curve was obtained by a Monte Carlo simulation code, developed at IPEN. In this code, all details of the detection system are modeled and the response curves for x-rays and gamma rays are calculated by the MCNPX radiation transport code. The gamma spectra were analyzed by Alpino code, which applies the method of numeric peak integration of the area under the photopeaks. For gamma emitter impurities, not visually detected, the decision threshold and the detection limits were calculated from the background count rate, under the peak area. The radiopharmaceutical solutions analyzed were {sup 67}Ga, {sup 99}Mo, {sup 99m}Tc, {sup 111}In, {sup 131}I, {sup 153}Sm, {sup 177}Lu and {sup 201}Tl. The results of impurities ratio for analyzed solutions are in accordance with the manufacturers' certificate and with the ANVISA. (author)

Development of an injectable formulation for the preparation of radiopharmaceutical {sup 68}Ga-DOTA-Sar gastrin; Desarrollo de una formulacion inyectable para la preparacion del radiofarmaco {sup 68}Ga-DOTA-Sargastrina

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Castillo P, M.

2015-07-01

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{sub 2}) have been proposed as potential diagnostic radiopharmaceuticals for obtaining tumors images with CCK2 receptors over expressed. The {sup 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 {sup 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 {sup 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 {sup 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 validation single-dose prepared under protocols of good manufacturing practices in the production plant of radiopharmaceuticals of the Instituto Nacional de Investigaciones Nucleares (ININ), meet the predetermined specifications to obtain a sterile formulation and free of bacterial endotoxins, with radiochemical purities greater that 95% and retains its quality characteristics. Finally, the necessary technical documentation was verified to integrate the legal record of the radiopharmaceutical {sup 68}Ga-DOTA-Sar gastrin in its presentation at single-dose with documented evidence of the quality and safety of the radiopharmaceutical, which is stable long enough for distribution and use in diagnostic imaging with PET technique of medullar thyroid tumors, lung and ovarian. (Author)

Therapeutical radiopharmaceuticals based In vivo generator system [{sup 166} Dy] Dy/{sup 166} Ho; Radiofarmacos terapeuticos basados en un sistema de generador In vivo [{sup 166}Dy] Dy/{sup 166}Ho

Energy Technology Data Exchange (ETDEWEB)

Ferro F, G.; Garcia S, L.; Monroy G, F.; Tendilla, J.I. [Gerencia de Aplicaciones Nucleares en la Salud, ININ, A.P. 18-1027, 11801 Mexico D.F. (Mexico); Pedraza L, M.; Murphy, C.A. de [Departamento de Medicina Nuclear, Instituto Nacional de Pediatria, Mexico D.F. (Mexico)

2002-07-01

At the idea to administer to a patient a molecule containing in it structure a father radionuclide, with a half life enough large which allows to the radiolabelled molecule to take up position specifically in a white tissue and decaying In vivo to the daughter radionuclide with properties potentially therapeutic, it is known as In vivo generator system. In this work the preparation and the preliminary dosimetric valuations of radiopharmaceuticals based In vivo generator system {sup 166} Dy Dy/{sup 166} Ho for applications in radioimmunotherapy, in the treatment of the rheumatoid arthritis and in the bone marrow ablation (m.o.) for candidates patients to bone marrow transplant are presented. (Author)

Lyophilized kits of diamino dithiol compounds for labelling with {sup 99m}-technetium. Pharmacokinetics studies and distribution compartmental models of the related complexes; Conjuntos de reativos liofilizados de compostos diaminoditiolicos para marcacao com tecnecio-99m. Estudo farmacocinetico e elaboracao de modelos compartimentalizados dos respectivos complexos

Energy Technology Data Exchange (ETDEWEB)

Araujo, Elaine Bortoleti de

1995-07-01

The present work reflects the clinical interest for labelling diamino dithiol compounds with technetium-99m. Both chosen compounds, L,L-Ethylene dicysteine (L,L-EC) and L,L-Ethylene dicysteine diethyl esther (L,L-ECD) were obtained with relative good yield and characterized by IR and NMR. The study of labelling conditions with technetium-99m showed the influence of the type and mass of reducing agent as well as the pH on the formation of complexes with desired biological characteristics. Radiochemical purity was determined by thin layer chromatography (TLC) and high performance liquid chromatography (HPLC). Lyophilised kits of L,L-EC and L,L-ECD for labelling with {sup 99m}Tc were obtained, with stability superior to 120 days, when stored under refrigeration, enabling the kits marketing. The ideal formulation of the kits as well as the use of liquid nitrogen in the freezing process, determined the lyophilization success. Distribution biological studies of the {sup 99m}Tc complexes were performed on mice by invasive method and on bigger animals by scintigraphic evaluation. Biological distribution studies of the complex {sup 99m}Tc-L,L-EC showed fast blood clearance, with the elimination of about 90% of the administered dose after 60 minutes, almost exclusively by the urinary system. The biological distribution results were adjusted to a three compartmental distribution model, as expected for a radiopharmaceutical designed to renal dynamic studies, with tubular elimination. The complex interaction with renal tubular receptors is related with structural characteristics of the compound, more specifically with the presence and location of polar groups. In comparison with {sup 99m}Tc-L,L-EC, biological studies of the complex {sup 99m}Tc -L,L-ECD showed different distribution aspects, despite some structural similarities. The presence of ethyl groups confers to the complex neutrality and lipophilicity. It cross the intact blood brain barrier and is retained in the brain for enough period, permitting the acquisition of scintigraphic cerebral images. The cerebral retention of the complex, and also its relative fast elimination are related to the metabolization of the compound to more polar species, identified in the urine and bile HPLC. The lipophilicity of the complex determine high liver uptake and intestinal elimination of the compound. Biological distribution of the complex {sup 99m}Tc-L.L-ECD was adjusted to a compartmental distribution model composed by seven compartments, characterized by a fast blood clearance, an unidirectional renal depuration and intestinal elimination, determined by intense hepato-biliary transit. (author)

Development of a lyophilized formulation for preparing the radiopharmaceutical {sup 177}Lu-DOTA-Anti-CD20; Desarrollo de una formulacion liofilizada para la preparacion del radiofarmaco {sup 177}-DOTA-Anti-CD20

Energy Technology Data Exchange (ETDEWEB)

Serrano E, L. A.

2015-07-01

The radiolabeled proteins are molecules of interest in nuclear medicine for their diagnostic and therapeutic application in cancer. Antibodies, such as chimeric monoclonal antibody Anti-CD20 rituximab, have established themselves as suitable vectors of radionuclides (e.g. {sup 177}Lu) , introducing high affinity by the surface antigens over- expressed and widely distributed in cells involved in certain diseases. The aim of this work was to design, optimize and document the production process of radiopharmaceutical {sup 177}Lu-DOTA-Anti-CD20 for sanitary registration request to the Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS). First, a raw material analysis using the Ft-Mir technique and gamma spectrometry was performed. Then, was carried out the development of the lyophilized formulation for the preparation of {sup 177}Lu-DOTA-Anti-CD20, in which an ANOVA was performed where the dependent variable was the radiochemical purity. The optimal pharmaceutical formulation was: 5 mg DOTA-CD20 and 80 mg Mannitol to be reconstituted with 1 m L of acetate buffer 0.25 M, ph 7, with an incubation time of 15 min at 37 degrees Celsius in a dry bath. Once completed the development of the lyophilized formulation, we proceeded to the optimization of the production process, development and validation of the analytical method. Three batches were prepared under protocols of Good Manufacturing Practice, which met pre-established specifications as sterile and endotoxin-free of bacterial formulations, with greater that 95% of radiochemical purity. Currently, is conducting the study of shelf stability. Upon completion of the stability studies, the legal record of {sup 177}Lu-DOTA-Anti-CD20 will be integrated with documented evidence of the quality and stability of the formulation of this radiopharmaceutical. (Author)

Internal dose assessment in nuclear medicine: fetal doses due to radiopharmaceutical administration to the mother; Dosimetria interna en medicina nuclear: dosis absorbida en el feto por la administracion de radiofarmacos a la madre

Energy Technology Data Exchange (ETDEWEB)

Rojo, Ana M; Michelin, Severino C

2004-07-01

The objective of this publication is to present a guideline for the dose assessment through a comprehensive introduction of knowledge on ionizing radiation, radiation protection during pregnancy and fetal dosimetry for physician and other professionals involved in nuclear medicine practices. It contains tables with recommended dose estimates at all stages of pregnancy for many radiopharmaceuticals. Compounds for which some information was available regarding placental crossover are shown in shaded rows. It includes the most common diagnostic and therapy practices in nuclear medicine considering the four radioactive isotopes selected: {sup 99m}Tc, {sup 131}I, {sup 201}Tl and {sup 67}Ga. There is a special case included, it is when conception occurs after the iodine has been administered. In almost every case, the diagnostic benefit to the mother outweighs the risk of any irradiation of the fetus. However, there is one situation in which severe fetal injury can be incurred from administering a radiopharmaceutical to the mother, and that is use of iodine-131 therapy for ablation of the thyroid in cases of hyperthyroidism or carcinoma. Radioactive iodine readily crosses the placenta and concentrates in the fetal thyroid, where, because of its small organ mass, high radiation doses are received. (author)

Evaluation of radiochemistry purity and p H of radiopharmaceuticals in nuclear medicine services at Pernambuco, Brazil; Avaliacao da pureza radioquimica e pH de radiofarmacos em servicos de medicina nuclear de Pernambuco, Brasil

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Andrade, Wellington; Lima, Fabiana Farias de, E-mail: falima@cnen.gov.b [Universidade Federal de Pernambuco (UFPE), Recife, PE (Brazil); Santos, Poliane A.L.; Lima, Fernando Roberto de Andrade; Lima, Fabiana Farias de, E-mail: fflima@cnen.gov.b [Centro Regional de Ciencias Nucleares (CRCN-NE/CNEN-PE), Recife, PE (Brazil)

2011-07-01

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)

Effect of mitomycin-c on biodistribution of 99 mTc-sodium pyrophosphate radiopharmaceuticals in mice; Efeito da mitomicina-c na biodistribuicao do radiofarmaco pirofosfato de sodio marcado com Tecnecio-99m em camundongos

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Gomes, Maria L.; Braga, Ana C.S.; Gutfilen, Bianca; Bernardo-Filho, Mario [Instituto Nacional do Cancer, Rio de Janeiro, RJ (Brazil)

1997-12-01

The desirable characteristics of technetium-99 have stimulated the development of labeling techniques for different molecular and cellular. It is generally acceptable that a variety of factors other than disease can alter the biodistribution of radiopharmaceutical and one such factor is the drug therapy. The absence of knowledge of these factors may result in an unexpected behavior of the radiopharmaceutical. Since patients on chemotherapeutic treatment ca be submitted, for different reasons, to a nuclear medicine procedure, we have studied in mice, the effect of mitomycin-C on the biodistribution of the radiopharmaceutical {sup 99m} Tc-pyrophosphate ({sup 99m} Tc-PYP). Mitomycin-C is an antineoplastic agent obtained from Streptomyces caesptosus. It was administered 0,15 mg of mitomycin-C in Balb/c in Balb/c female mice with an interval of 72 hours. After one hour of the last dose, 0.3 ml of {sup 99m} Tc-PYP (7.4 MBq) were injected after 0.5 h the animals were sacrificed. The organs were isolated, weighted and counted in a well counter. The percentages of radioactivity per gran of organs (% rad/g) were calculated and statistics analyses were performed (wilcoxon). The results have shown that the % rad/g has increased in pancreas, stomach, bone and lungs. These increased of radioactivity can be justified by the metabolic process or the therapeutic effect of mitomycin-C. (author). 8 refs., 2 tabs.

Biotechnological application of protein Leuc-B isolated from Bothrops leucurus venom as a prototype for antitumoral radiopharmaceutical;Aplicacao biotecnologica da proteina Leuc-B isolada da peconha de Bothrops leucurus como prototipo de radiofarmaco antitumoral

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Gabriel, Lucilene Marcia

2010-07-01

According to the report of the International Agency for Research on Cancer, the growth of this disease implies the death of 17 million people a year by 2030. Although the knowledge on development of cancer is growing considerably, just a few advances in the diagnosis and therapy has been achieved. Faced with this scenario, it is clear the need for new substances more specifics with low toxicity to the patient, which can be used for diagnosis and treatment of cancer. Membrane receptors over expressed in tumor cells are promising target candidates for development of diagnostic and therapeutical tools. Integrins are a family of hetero dimeric cell surface adhesion receptors able to recognize and bind to proteins in the extracellular matrix (ECM). This recognition is mainly through the RGD domains presents in both the cell surface as in the protein from the ECM. Various integrins have been identified as regulators of tumor progression. The RGD domain is also found in some snake venoms named disintegrins. Disintegrins inhibit cell-matrix and a cell-cell interactions mediated by integrins and it has been shown that these proteins are able to inhibit metastasis in processes dependent on integrin. The disintegrin-like (ECD), as well as RGD-disintegrin are also able to bind to cell surface integrins and inhibit their adhesion to the natural ligands. In this work it was purified from Bothrops leucurus venom (VBL), a metalloproteinase-class P-III with disintegrin-like domain (ECD), Leucurolisina B (Leuc-B). This metalloproteinase and the crude venom were used to evaluate their applicability in the differential detection of tumors. In vitro results demonstrated that both VBL and Leuc-B have potent antitumoral effect on several cancer cell lines: U87, T98, RT2 (glioblastoma), MCF7 (breast), Ehrlich and UACC (melanoma) with IC{sub 50} values of approximately 0.6 muM. The morphological changes observed in these strains when treated with Leuc-B, and data from the DAPI staining solution and acridine/ethidium bromide indicate that the antitumoral effect of these substances occurs via apoptosis. Radioactive probes of Leuc-B ({sup 131}/{sup 125}I-Leuc-B) were synthesized with high specific activity and high radiochemical purity. Biodistribution studies, performed by intravenous injection and intratumoral flow in mice bearing Ehrlich tumor showed a significant tumor uptake Leuc-B ( p <0.05). These results show the potential of Leuc-B as a template for the development of drugs and radiopharmaceuticals for diagnosis and therapy of tumors. (author

Survey or quality for radiopharmaceuticals and activimeters available in services of nuclear medicine from Recife, Pernambuco State, Brazil; Estudo da qualidade dos radiofarmacos e dos activimetros utilizados nos servicos de medicina nuclear do Recife

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Nogueira, Fernanda Maria Dornellas Camara

2001-08-01

The radiopharmaceutical used in Nuclear Medicine must present high chemical and radiochemical purities in order to obtain images with contrast and clearness adequate for the diagnosis. Test should be made by the Nuclear Medicine institutes to evaluate the presence of molybdenum, aluminium and the free Tc O{sub 4}{sup -}/TC-HR in the radiopharmaceutical before they use it. On the other hand, the activity to be administered to the patient is determined by the activimeters available in the Nuclear Medicine institutions. So it is necessary to perform tests to verify operating conditions of the activimeter to guarantee that the dose received by patient is the prescribed by the physician. In Brazil, few clinics of Nuclear Medicine are implanting the tests of the radiopharmaceutical and of the activimeters. The objective of this work is to establish the procedures for the radiopharmaceutical tests and to evaluate the quality of the radiopharmaceutical used at the clinics of Recife, as well as the operation conditions of the activemeters in these institutions. The results show that all the activimeters analyzed present a good performance and that the equipment with Geiger-Muller detectors present larger instability than the ones that use ionization chamber. Concerning the Mo/Tc generators, it was observed that only one presented Mo in the generator eluate with concentration over the acceptable limits and that the concentration of Al found in the samples analyzed were below the limits. On the other hand, in 73% of the MIBI analyzed samples were observed problems with its preparation that were caused by the procedures adopted at the clinics, which do not follow the manufacturers recommendations. (author)

Effect of the peptide Tat(49-57) on the bio-distribution and similar radiopharmaceuticals dosimetry of the bombesin; Efecto del peptido TAT(49-57) sobre la biodistribucion y dosimetria de radiofarmacos analogos de la bombesina

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Santos C, C. L.

2011-07-01

The gastrin-releasing peptide receptor (GRP-r) is over-expressed in prostate and breast cancer. {sup 99m}Tc-Bombesin ({sup 99m}Tc-Bn) has been reported as a radiopharmaceutical with specific cell GRP-r binding. The HIV Tat(49-57)-derived peptide has been used to deliver a large variety of molecules to cell nuclei. New hybrid radiopharmaceuticals of type {sup 99m}Tc-N{sub 2}S{sub 2}-Tat(49-57)-Lys{sup 3}-Bn ({sup 99m}Tc-Tat-Bn) and {sup 188}Re-N{sub 2}S{sub 2}-Tat(49-57)-Lys{sup 3}-Bn ({sup 188}Re-Tat-Bn), would increase cell uptake and internalized in cancer cell nuclei could act as an effective system of targeted radiotherapy using Auger and internal conversion (I C) electron emissions near DNA. The aim of this research was to prepare and assess in vitro and in vivo uptake kinetics in cancer cells of {sup 99m}Tc/{sup 188}Re-Tat-Bn and the in vitro nucleus and cytoplasm internalization kinetics in GRP receptor-positive cancer cells as well as to evaluate the subcellular-level radiation absorbed dose associated with the observed effect on cancer cell DNA proliferation. Structures of N{sub 2}S{sub 2}-Tat-Bn and Tc/Re(O)N{sub 2}S{sub 2}-Tat-Bn were calculated by an Mm procedure. {sup 99m}Tc-Tat-Bn and {sup 188}Re-Tat-Bn were synthesized and stability studies carried out by HPLC and I TLC-Sg analyses in serum and cysteine solutions. In vitro internalization was tested using human prostate cancer Pc 3 cells and breast carcinoma cell lines MDA-Mb 231 and MCF 7. Nuclei from cells were isolated using a nuclear extraction kit. Total disintegrations in each subcellular compartment were calculated by integration of experimental time activity kinetic curves. Nucleus internalization was corroborated by con focal microscopy images using immunofluorescent labelled Tat-Bn. Biodistribution was determined in Pc 3 tumor-bearing nude mice. The Penelope code was used to simulate and calculate the absorbed dose by contribution of {beta}, Auger and I C electrons in the cytoplasm and nucleus using geometric models built from immunofluorescent cell images. A cell proliferation kit was used to evaluate DNA concentration after cancer cell incubation with {sup 99m}Tc-Tat-Bn. Results showed a minimum energy of 271 kcal/mol for N{sub 2}S{sub 2}-Tat-Bn and 300 kcal/mol for Re/Tc(O)N{sub 2}S{sub 2}-Tat-Bn. {sup 99m}Tc/{sup 188}Re-Tat-Bn radiochemical purity was >90%. In vitro studies demonstrated stability in serum and cysteine solutions, specific cell receptor binding and internalization in three cell lines was significantly high. The tumor-to muscle radioactivity ratio was 8.5 for {sup 99m}Tc-Tat-Bn. Also it showed that 59.7%, 61.2% and 41.5% of total disintegrations per unit of {sup 99m}Tc-Tat-Bn activity (1 Bq) bound to the cell occurred in the nucleus of Pc 3, MCF 7 and MDA-Mb 231, respectively and 63.36%, 65.70% and 45.55% of total disintegrations per 1 Bq of {sup 188}Re-Tat-Bn bound to the cell occurred in the nucleus of these three cell lines respectively. The {sup 99m}Tc-Tat-Bn absorbed doses delivered to nuclei were 0.142 mGy/Bq{center_dot}s (Pc 3), 0.434 Gy/Bq{center_dot}s (MCF 7) and 0.276 mGy/Bq{center_dot}s (MDA-Mb 231) and from {sup 188}Re-Tat-Bn were 0.156 mGy/Bq{center_dot}s (Pc 3); 0.368 mGy/Bq{center_dot}s (MCF 7) and 0.251 mGy/Bq{center_dot}s (MDA-Mb 231). {sup 99m}Tc-Tat-Bn produced a significant decrease in cellular proliferation of Pc 3 (52.98%), MCF 7 (45.71%) and MDA-Mb 231 (35.80%) with respect to untreated cells. These hybrid radiopharmaceuticals are potentially useful in imaging and therapy of breast and prostate cancer. (Author)

Sentinel lymph node identification in breast cancer using periareolar and subdermal injection of the radiopharmaceutical in four points; Identificacao do linfonodo sentinela no cancer de mama com injecao subdermica periareolar em quatro pontos do radiofarmaco

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Coelho-Oliveira, Afranio; Rocha, Augusto Cesar Peixoto [Hospital Universitario Clementino Fraga Filho, Rio de Janeiro, RJ (Brazil). Servico de Ginecologia]. E-mail: afranioliveira@hotmail.com; Gutfilen, Bianca; Pessoa, Maria Carolina Pinheiro; Fonseca, Lea Mirian Barbosa da [Universidade Federal, Rio de Janeiro, RJ (Brazil). Faculdade de Medicina. Dept. de Radiologia e Medicina Nuclear

2004-08-01

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)

Internal dosimetry of radiopharmaceuticals derived of antitumor polypeptide isolated from venoms: Crotalus durissus terrifucus and Scorpaena plumieri;Dosimetria interna de radiofarmacos derivados de polipeptideos antitumorais isolados dos venenos de: Crotalus durissus terrificus e Scorpaena plumieri

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Andrade, Henrique Martins de

2009-07-01

The identification of new diagnostic and therapeutic agents capable of inhibiting tumor growth is essential for improving the prognosis of patients suffering from malignant tumors (glioma, breast and others). In this context, natural products (plants and animals) are a rich source of substances with potential antitumor. Despite knowledge of the etiology and pathology of tumors little progress has been observed in the area of diagnosis. Molecules of snake venoms have been shown to play an important role not only in the survival and proliferation of tumor cells but also in the process of tumor cell adhesion, migration and angiogenesis. Polypeptides isolated from the venom of the snake, Crotalus durissus terrificus, Crtx, and Scorpaena plumieri fish, SPGP, have antitumor activity against malignant tumors. It was shown that similar radio iodines Crtx and SPGP, {sup 125}I-Crtx and {sup 125}I-SPGP, can interact specifically with malignant tumors and induce cell death. Prototype-based radiopharmaceuticals Crtx and SPGP containing radioiodine 1311 were able to produce diagnostic images to accumulate specifically in the tumor site. The present study aimed at evaluating the potential radiological safety and diagnostic/therapeutic efficacy of {sup 131}I-Crtx {sup l31}I-SPGP and (evaluated from the biokinetic data in mice bearing Ehrlich tumor) were treated by the MIRD formalism to carry out internal dosimetry studies. Absorbed doses due to the uptake of {sup 131}I-Crtx and {sup 131}I-SPGP were determined in various organs of mice and implanted into the tumor. The results obtained for the animal model were extrapolated to humans by assuming a similar concentration ratio among the various tissues between mice and humans. In extrapolation, we used the masses of human organs of the phantom of Cristy/Eckerman. Both radiation penetrating and non penetrating of {sup 131}I on the tissue were considered in dose calculations. The absorbed dose in the bone marrow due to the administration of {sup 131} I-Crtx was 0.01 mGy/370MBq for both intravenous injection and for the intratumoral injection. In tumor, the value was 3.28 mGy/370MBq for intravenous injection and 107.18 mGy/370MBq for intratumoral injection. For the administration of {sup 131}I-SPGP values for the bone marrow were 1.34 mGy/370MBq for intravenous injection and 0.12 mGy/370MBq for intratumoral injection. In tumor, 256.29 mGy/370MBq for intravenous injection and 895.69 mGy/370MBq for intratumoral injection. The results suggest good radiation safety for both radiopharmaceuticals considering the values found for the bone marrow by both intratumoral and intravenous routes, in view of the importance of this body to generate blood cells. The results for the tumor intravenously indicate diagnostic applicability for both molecules. Through intratumoral, the values suggest the feasibility for use of {sup 131}I-Crtx and of {sup 131}I-SPGP as a therapeutic agent, given the persistence of radioactivity in the tumor site. Although {sup 131}I-Crtx has proved to be more secure for applications in diagnosis, its potential for application in internal radiotherapy is lower than that of {sup 131}I-SPGp. Both {sup 131}I-Crtx and {sup 131}I-SPGP, proved to be good prototypes for the development of radiopharmaceuticals. This study indicates that is necessary the synthesis of analogues with lower uptake in healthy organs and a higher tumor uptake, as well as pharmaceutical formulations, using nano technology, such as liposomes, nano-materials for controlled release of drugs. (author)

Evaluation of occupational radiation dose in nuclear medicine: radiopharmaceutical administration to scintiscanning exams of myocardial perfusion; Avaliacao da dose de radiacao ocupacional em medicina nuclear: administracao de radiofarmacos em exames de cintilografria de perfusao miocardica

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Komatsu, Cassio V., E-mail: cassiok@yahoo.com [Medicina Nuclear do Triangulo (MNT), Uberlandia, MG (Brazil); Michelin, Charlie A.; Jakubiak, Rosangela R., E-mail: charlie@utfpr.edu.br, E-mail: requi@utfpr.edu.br [Universidade Tecnologica Federal do Parana (UTFPR), Curitiba, PR (Brazil); Lemes, Alyne O.; Silva, Juliana L.M., E-mail: alyne275@gmail.com, E-mail: jujumontesdocinho@gmail.com [Faculdade do Trabalho (FATRA), Uberlandia, MG (Brazil)

2013-11-01

In nuclear medicine, workers directly involved in exams are constantly exposed to ionizing radiation. The procedure for administration of the radiopharmaceutical to the patient is one of the most critical times of exposure. In tests of myocardial perfusion scintigraphy (MPS) administration of radiopharmaceutical repeats the steps of rest and cardiac stress. In this study, we used a Geiger -Mueller detector for measuring occupational radiation doses for during the administration of technetium- {sup 99m}- sestamibi in MPS tests. In the evaluation, discriminated the stages of examination and related professional experience time to doses measures at home. It were followed 110 procedures at home (55 conducted by professionals with over 5 years experience and 55 conducted by professionals with less than 1 year of experience) and 55 effort procedures. The results showed that the rest of the procedure time and dose are related to the experience of the worker. More experienced workers were faster (mean: 43 {+-} 16 vs 67 {+-} 25 seconds / procedure), and therefore received lower doses (mean 0.57 {+-} 0.16 versus 0.80 {+-} 0.24 {mu}Sv / procedure), both with statistical significance (p <0.001). In step effort, there were procedures lasting longer (mean: 19 {+-} 2 minutes / procedure), which resulted in higher doses (mean 3.0 {+-} 0.6 {mu}Sv / procedure)

Automated system for the management of the radiological safety in a radiopharmaceutical and labelled compounds production center; Sistema automatizado para la gestion de la seguridad radiologica un centro de produccion de radiofarmacos y compuestos marcados

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Amador B, Z.H. [Centro de Isotopos, Ave. Monumental y Carretera La Rada, Km. 3, Guanabacoa, Apartado 3415, Ciudad de La Habana (Cuba); Alvarez Builla de Sologuren, E. [Centro de Gestion de Informacion y Desarrollo de la Energia, Cale 20 No. 4111 e/47y 18A, Playa, Ciudad de La Habana (Cuba)]. e-mail: zabalbona@centis.edu.cu

2006-07-01

The establishment in the Center of Isotopes of Cuba of a managerial quality system in matter of radiological safety Y the accumulated operational experience, its constitute the foundations for the development of a system of management of the radiological safety organically structured, with the application of evaluative techniques of it management Y it integration in an automated system. The Visual Basic 5 platform for the programming of the 'SASR' system is used. The functions of each one of the 11 modules that integrate it are described. With this it can be carried out the registration of the data of the training Y the personnel's authorization, the checkup of the radioactive inventory of the installation, the annual upgrade of the registrations of the individual doses of those workers, the analysis of the state of the available equipment for magnitude to control, the radiological situation of the work positions, the public exposure by the gassy discharges, the experiences of the radiological events, the annual consolidation of the costs of the safety Y the evaluation of indicators Y of tendencies. A computer tool that facilitates the effective management of the radiological safety in a radioactive installation is obtained. (Author)

Formulation of an inhibitor radiopharmaceutical of prostatic antigen of {sup 177}Lu-Glu-Nh-CO-Nh-Lys membrane; Formulacion de un radiofarmaco inhibidor del antigeno prostatico de membrana {sup 177}Lu-Glu-NH-CO-NH-Lys

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Ortega S, D.

2015-07-01

The prostate specific membrane antigen (PSMA) is a zinc metalloenzyme that is expressed on the cell membrane and highly expressed in prostate cancer. Recently, it has been demonstrated that the peptide sequence Glu-Nh-CO-Nh-Lys inhibit PSMA activity through an electrostatic interaction with the Zn. Several theragnostic radiopharmaceuticals with base in {sup 177}Lu have been developed for radiotherapy of specific molecular targets because gamma and beta emissions of the radionuclide (β = 0.498 MeV and γ= 0.133 MeV). However, there is currently no label a formulation for preparing a radiopharmaceutical of {sup 177}Lu-Glu-Nh-CO-Nh-Lys useful treatment of prostate cancer. The aim of this research was to optimize and document the process of production of the radiopharmaceutical {sup 177}Lu-Glu-Nh-CO-Nh-Lys for sanitary registration application before the Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS). The optimization of the production process was assessed a factorial design of three variables with mixed levels (3 x 3 x 2) where the dependent variable is the radiochemical purity, the analytical method was validated by UV-Vis spectrophotometry. Next, process validation was carried out by labeling 3 lots of the optimized formulation of the radiopharmaceutical (5.55 GBq (2.16 μg) of {sup 177}LuCl{sub 3}, 90 mg peptide PSMA, 50 mg ascorbic acid and 150 μL of acetate buffer 1 M ph 5), long-term stability was performed by high resolution liquid chromatography) to determine its useful shelf life. 3 validation batches were prepared under protocols of Good Manufacturing Practice (GMP) in the Production Plant of Radiopharmaceuticals of the Instituto Nacional de Investigaciones Nucleares (ININ), meet specifications preset by obtaining a sterile and free development of bacterial endotoxin yields of labeled 100% and which retains its quality characteristics radiochemical purity greater than 90% for at least 15 days. (Author)

Study of the production of the radiopharmaceutical {sup 18}F-FLT in automated system: contribution for process validation; Estudo da producao do radiofarmaco FLT-{sup 18}F em sistema automatizado: contribuicao para a validacao do processo

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Zanette, Camila

2013-07-01

Radiopharmaceutical {sup 18}F-FLT is a thymidine nucleoside analogue and a promising tumor proliferation marker for PET images. The synthesis of this radiopharmaceutical is not simple, and often has low yields. This radiopharmaceutical has already been studied for some years; however, there is no production, nor are there clinical studies in Brazil. The study of the production process and its compliance with the guidelines of Good Manufacturing Practices (ANVISA) are of extreme importance. This study aimed to investigate the synthesis of this radiopharmaceutical, evaluate methods of quality control that will be used in future production routines, perform cytotoxicity studies, biodistribution studies and PET imaging in animals, thereby contributing to the development and elaboration of the process validation protocol and to the establishment of analytical methods to be used during production routines. Initially, we studied the synthesis and production of {sup 18}F-FLT, with the evaluation of three different temperatures of radiolabeling to check the behavior of the radiochemical yield and stability of the nal product. Studies of analytical methodology comprised the analysis of radionuclide identification, determination of chromatographic profiles, radiochemical purity, residual solvents, and pH. In vitro studies of internalization and cytotoxicity were also carried out. In in vivo studies, we evaluated the pharmacokinetics, biodistribution in healthy animals and in animals with tumor models, in addition to PET/CT images in animals with melanomas. The final product had high radiochemical purity and was stable for up to 10 hours after the synthesis, but got a relatively low radiochemical yield, as described in the literature. The tested analytical methods proved suitable for use in the quality control of {sup 18}F-FLT. In in vitro studies, {sup 18}F-FLT showed a significant percentage of binding to tumor cells, and the nonradiolabeled molecule was not considered toxic for these studied cells. The biodistribution and images showed results that were consistent with expectations. Contributions to the validation process were satisfactory, and will assist in the future validation of the production process of the radiotracer under study. (author)

Study and determination of the influence factors of the radiopharmaceutical vials dimensions used for actimeter calibration at IPEN; Estudo e determinacao de fatores de influencia das dimensoes dos frascos de radiofarmacos utilizados no IPEN para calibracao de ativimetros

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Martins, Elaine Wirney

2010-07-01

The efficiency and safety of the nuclear medicine practice depend, among others factors, of a quality control programme, mainly related to the use of the nuclide activity meters (activimeter). One of the most important sources of errors in the activimeter measurements is the thickness, size and volume of the vial that contains the radiopharmaceutical considering that a typical activimeter has its response dependent of the vial used. The objective of this work was to establish a quality control programme and the correction factors for the geometry of the vials used for distribution of radiopharmaceutical and activimeters calibration, considering that the Calibration Laboratory of Instruments (LCI) of the Instituto de Pesquisas Energeticas e Nucleares (IPEN) has a NPL-CRC Secondary Standard Radionuclide Calibrator System, manufactured for the Southern Scientific plc, compound by an ionization chamber well type and a current measurement system, with traceability to National Physical Laboratory (NPL) and calibrated with a P6 vial type with different dimensions of the one used for the IPEN. The radiopharmaceutical produced by IPEN {sup 67}Ga, '1{sup 31}I, {sup 201}Tl and {sup 99}mTc, had been tested using the two different vials. The results shown a maximum variation of 22% for {sup 201}Tl, and the minimum variation was 2.98% for {sup 131}I. The correction factors must be incorporated in the routine calibration of the activimeters. (author)

The prognostic role of {sup 99m}Tc-MDP breast scintigraphy. Comparison of scintigrafic findings with histologic and molecular parameters; Significato prognostico della scintigrafia mammaria con {sup 99m}Tc-MDP. Confronto con parametri istologici e molecolari

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Dimonte, M. [Centro di Medicina Nucleare Calabrese, Lecce (Italy); Leo, G. [Azienda Ospedaliera V. Fazzi, Laboratorio Analisi, Lecce (Italy); Marsigliante, S. [Lecce Univ., Lecce (Italy). Dipt. di Biologia, Laboratorio di Fisiologia; Manca, C. [Azienda Ospedaliera V. Fazzi, Chirurgia Generale, Lecce (Italy)

1999-11-01

Breast scintigraphy (BS) with the bone-seeking agent {sup 99m}Tc-medronate (MDP) can be usefully combined with mammography to diagnose and characterize questionable breast lumps. However this radiotracer does not seem to provide any further prognostic information about breast cancer. Therefore it is investigated the prognostic yield of MDP-BS searching for correlations between scintigraphic findings and the major biological and histologic parameters. It is retrospectively analyzed a series of 44 primary breast cancers. All patients had undergone {sup 99m}Tc-MDP bone scan for preoperative staging, as well as conventional breast imaging. It is statistically compared the cancer/background ratio (c/b index) with lesion histotype, diameter, grading, and the tissue concentrations of steroid receptors, cathepsine D, type 1 timidine kinase, pS2 and p53 proteins. Differently from BS with {sup 99m}Tc-MIBI, {sup 201}Tl, {sup 18}F-FDG, {sup 111}In-OCT and radiolabeled estrogens and despite its good overall accuracy, MDP-BS appears to have no prognostic role. In fact, despite the well-known capability of soft tissue lesions to take up the tracer, MDP tumor trapping seems to depend mainly on the increased permeability of neo vessels and on interstitial space enlargement. Few reports are available in the literature on the correlation between in vivo MDP uptake by the breast cancer and prognostic parameters. Thus, it are tested possible correlations between the amount of MDP taken up by the breast cancer, histologic features and cell concentrations of some major biomarkers. The lack of any statistical significance is in agreement with the theory, and confirms the little prognostic value of MDP-BS. Nevertheless, further trials are warranted on larger series of cases to validate personal findings. [Italian] La scintigrafia mammaria (SM) con {sup 99m}Tc-medronato (MDP) sfrutta la ben nota capacita' di alcuni tumori extraossei di fissare tale radiofarmaco osteotropo. In

Preparation of the radiopharmaceutical {sup 99m} Tc-HYNIC-cyclo-Lys-D-Phe-RGD for In vivo image of integrines; Preparacion del radiofarmaco {sup 99m} Tc-HYNIC-ciclo-Lys-D-Phe-RGD para imagen In vivo de integrinas

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Hernandez H, E [ININ, 52750 La Marquesa, Estado de Mexico (Mexico)

2007-07-01

The diagnostic of some pathological processes by means of images constitutes one of the used methods in the determination of the origin, condition and/or evolution of one illness. The use of contrast agents in conjunction with other techniques help to the obtaining and visualization of complex systems, among these we can find to those radiopharmaceuticals used in nuclear medicine to visualize diverse organs and corporal systems. At the moment it is sought to develop a radiopharmaceutical of third generation that can be used for image In vivo of integrines with the purpose of detecting angio genesis processes, that which would allow to diagnose in way it specifies a wide range of primary tumors and their metastasis. Presently work it developed the radiopharmaceutical {sup 99m}Tc-HYNIC-cycle-Lys-D-Phe-RGD, likewise the good conditions were determined for the formation of this complex. The HYNIC was employee as chelating agent, using as co ligands EDDA and Tricine for to complete the sphere of coordination of the {sup 99m}Tc. The conjugated HYNIC-RGD was synthesized, purified, characterized and radiolabelled In situ with {sup 99m}Tc using High pressure liquid chromatography as analysis method in Reverse Phase (RP-HPLC). By this way it was developed the lyophilized formulation for its instantaneous labelled to which were carried out quality control tests. The one conjugated was obtained free of impurities, showing stability at same as their complex formed with {sup 99m}Tc. The analysis method was validated turning out to be necessary, exact, lineal and specific for the quantification of the analyte of interest. The lyophilized formulation showed a radiochemical purity bigger than 95%, besides being sterile and free of pyrogens. The biodistribution tests in athymic mice with induced tumors showed that the radiopharmaceutical was united mainly to the tumor and that this it was excreted mainly for renal via. (Author)

Evaluation of mitomycin-C effect on biodistribution of {sup 99m}Tc-dimercaptosuccinic acid in BALB/C mice; Avaliacao do efeito da mitomicina-c na biodistribuicao do radiofarmaco acido dimercaptosuccinico marcado com tecnecio-99m em camundongos BALB/C

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Gomes, Maria Luisa; Britto, Deise Mara de M.; Freitas, Rosimeire de S.; Bernardo-Filho, Mario [Instituto Nacional do Cancer, Rio de Janeiro, RJ (Brazil). Centro de Pesquisa Basica; Braga, Ana Cristina de S.; Bezerra, Roberto Jose A.C. [Universidade do Estado, Rio de Janeiro, RJ (Brazil). Inst. de Biologia Roberto Alcantara Gomes. Dept. de Biofisica e Biometria

1999-11-01

The many desirable characteristics of technetium-99m have stimulated the development of labeling techniques for different molecular and cellular structures. It is accepted that a variety of factors such the drug chemotherapy can alter the biodistribution of radiopharmaceuticals. The unknowledge of these factor may result in an unexpected behavior of the radiopharmaceuticals. Since patients on chemotherapeutic treatment can be submitted to a nuclear medicine procedure, we have studied in mice, the effect of mitomycin-C on the {sup 99m} Tc-DMSA used for kidney scintigraphy. Mitomycin-C is an antineoplastic agent obtained from Streptomyces caesptosus. The metabolism of this drug produces different toxic and inactive metabolites. Mitomycin-C 0.15 mg was administered in Balb/c female with an interval of 72 hours. After one hour of the last dose, 0.3 ml of 9{sup 9m}c-DMSA (7.4 MBq) were injected and after 0.5 h the animals were sacrificed. The organs were isolated and counted in a well counter. The percentage of radioactivity (%ATI) were calculated and statistical analysis were performed (Wilcoxon Test). The results have shown that the %ATI: has increased in stomach and uterus, has decreased in kidney and ovary; has not altered in pancreas, spleen, lung, heart, liver, thymus, thyroid, bone and brain. The increase of % ATI could be justified by the metabolic process or the therapeutical effect of mitomycin-C. As an effect of this drug is observed in the uptake of the {sup 99m} Tc-DMSA by the kidney, probably an alteration in the kidney scintigraphy is expected. However, the increase of %ATI of this radiopharmaceutical in other organs by the mitomycin-C could be evaluated carefully. (author) 12 ref., 2 tabs.

Obtaining a metastasis model in vivo for the evaluation of the radiopharmaceuticals sensitivity labeled with {sup 99m}Tc; Obtencion de un modelo de metastasis in vivo para la evaluacion de la sensibilidad de radiofarmacos marcados con {sup 99m}Tc

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Gonzalez A, V. M.

2015-07-01

Nuclear medicine currently has a wide range of techniques that support the diagnosis of various diseases, including cancer that prevails as the most important. In the present research work was proposed to develop a model that would study the process known as metastasis, because this process is vital because most of the deaths in patients with some form of cancer are caused by metastasis. The objective was to obtain an in vivo model of metastasis induced with AR42J cells for studying the radiopharmaceuticals sensitivity labeled with {sup 99m}Tc. To achieve the objective proposed a study model in which it could make a real time evaluation of some radiopharmaceuticals with reported efficiency was development, in order to determine their sensitivity in similar conditions to the metastasis process. This required a mouse model that was used to observe a similar process to metastasis, inducing cells of the AR42J cell line, since these cells have good proliferation and have molecular targets for a minimum of 3 standardized radiopharmaceuticals. Was elected radionuclide {sup 99m}Tc, because of its low emission of radiation into the tissues, besides having a half life of 6 hours and provides a good visualization of anatomical structures. On the other hand the stable expression of green fluorescent protein in tumor cells appears to be a suitable tool for the detection of cancer development in early stages and the formation of in vivo micro metastases, so two fluorescence tests were performed and other by electrophoresis. The results showed that both study models can be carried out without increasing complexity and meeting the expectations expected for which they were designed. (Author)

Genotoxic and cytotoxic damage by the therapeutic radiopharmaceutical [{sup 166}Dy]Dy/{sup 166}Ho-EDTMP as in vivo generator system; Dano genotoxico y citotoxico por el radiofarmaco terpeutico [{sup 166}Dy]Dy/{sup 166}Ho-EDTMP como sistema de generador in vivo

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Pedraza L, M; Piedras R, J [Instituto Nacional de Ciencias Medicas y Nutricion, Salvador Zubiran. Vasco. de Quiroga 15, 14000 Mexico D.F. (Mexico); Ferro F, G; Morales R, P [ININ, Km. 36.5 Carretera Mexico-Toluca, Ocoyoacac, 52045 Estado de Mexico (Mexico); Murphy S, E [Hospital Santaelena, Mexico D.F. (Mexico); Hernandez O, O [Escuela Superior de Fisica y Matematicas, IPN, Mexico D.F. (Mexico)

2005-07-01

In patients with leukemias and multiple myeloma, the cure can be obtained to inclination of a bone marrow transplant (m.o.), for that which one is used a combination of external radiotherapy and chemotherapy with the consequent toxicity to healthy organs. The complex [{sup 166}Dy]Dy/{sup 166}Ho-ethylenediaminetetramethylenephosphonate ([{sup 166}Dy]Dy/{sup 166}Ho-EDTMP) it forms a generator system in vivo stable with bony selective likeness in mice therefore, this it could work as a therapeutic radiopharmaceutical for bone marrow ablation. The objective of this original work was to determine the genotoxic and cytotoxic damage produced by the [{sup 166}Dy]Dy/{sup 166}Ho-EDTMP like a generator system in vivo by means of the reticulocytes reduction (RET) and micronucleus elevation in reticulocytes (RET-MN) in peripheral blood and to evaluate its myeloablative potential for histopathologic studies. It was irradiated {sup 166}Dy{sub 2}O{sub 3} enriched and it was add in form {sup 166}DyCI{sub 3} to the EDTMP in a softening media of phosphates (pH 8), the optimal molar relationship {sup 166}Dy: EDTMP was 1.7:1 and the radiochemical purity was evaluated by ITLC. The Dy:EDTMP complexes, non radioactive, its were prepared in the same way with non irradiated dysprosium oxide. A group of BALB/c mice was injected intraperitoneally with the radiopharmaceutical and two groups of control mice were injected with the non radioactive complex and with sodium chloride 0.9% respectively. Before injecting each one of the solutions it was take a basal sample of peripheral blood of the mouse tail and each 48 h post-injection during 12 d. The animals were sacrificed to obtain the organs of interest and to determine the radioactivity in each one. The femur was used for the histopathologic studies. The quantification of the frequency of RET and RET-MN was carried out by flow cytometry of the sanguine samples and the Monte Carlo code MCNP4B for the dosimetry calculations was used. The radiochemical purity was 99% and in average the specific activity was of 1.3 MBq/mg. The RET and RET-MN frequencies were statistically significant among the treatments and at the end of the period of 12 d genotoxicity and cytotoxicity induced by the in vivo generator system was demonstrated. Those histologic studies showed complete and/or almost complete acellularity, that which it means suppression of the activity in the m.o. The absorbed dose in the m.o. it was 18- 23 Gy. The [{sup 166}Dy]Dy/{sup 166}Ho-EDTMP induces genotoxicity, cytotoxicity and a severe one myelosuppression in mice. Therefore, it is considered a radiopharmaceutical for the ablation of m.o. in human. (Author)

Evaluation of hemodynamic significance of coronary fistulae. Diagnostic integration between coronary angiography and stress/rest myocardial scintigraphy; Valutazione del significato emodinamico di fistole coronariche artero-venose. Integrazione diagnostica tra angiografia coronarica e scintigrafia miocardica a riposo e sotto sforzo

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Rubini, G.; Sebastiani, M. [Bari Univ., Bari (Italy). Cattedra di Medicina Nucleare; Ettorre, G. C. [Foggia Univ., Foggia (Italy). Cattedra di Radiologia; Bovenzi, F. [Ospedale Policlinico, Unita' Operativa di Cardiologia, Bari (Italy)

2000-12-01

'angiografia coronarica e con la tomografia con emissione di fotone singolo utilizzando il {sup 99m}Tecnezio- sestamibi come radiofarmaco indicatore della perfusione miocardica a riposo e sotto sforzo per la valutazione del significato emodinamico delle fistole coronariche arterovenose. Le fistole coronariche sono state riconosciute in 9 pazienti mediante angiografia coronarica. Tutti i pazienti sono stati sottoposti a esame obiettivo, ecocardiografia transtoracica, elettrocardiogramma da sforzo e la tomografia ad emissione di fotone singolo per la valutazione della perfusione miocardica a riposo e sotto sforzo. Con la tomografia con emissione di fotone singolo per la valutazione della perfusione miocardica a riposo e sotto sforzo e con l'elettrocardiogramma per la valutazione della perfusione a riposo e sotto sforzo con l'elettrocardiogramma da sforzo sono stati evidenziati segni di ischemia miocardica indotta dallo sforzo in 2 pazienti. (abstract truncated)

Automated system for the safe management of the radioactive wastes and liquid effluents in a Radiopharmaceutical an labelled compounds production center; Sistema automatizado para la gestion segura de los desechos radiactivos y efluentes liquidos en un centro de produccion de radiofarmacos y compuestos marcados

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Amador B, Z.H. [Centro de Isotopos, Ave. Monumental y Carretera La Rada, Km. 3, Guanabacoa, Apartado 3415, Ciudad de La Habana (Cuba); Guerra V, R. [Centro de Gestion de Informacion y Desarrollo de la Energia, Calle 20 No. 4111 e/47 y 18A, Playa, Ciudad La Habana (Cuba)]. e-mail: zabalbona@centis.edu.cu

2006-07-01

The Center of Isotopes of the Republic of Cuba is a radioactive installation of first category that executes the administration of their radioactive waste under authorization of the National Regulatory Authority. The principles of the design and operation of the 'SADR' system for the safe administration of the radioactive waste and liquid effluents are presented. The Visual Basic 6 platform for the programming of the SADR is used and through of their schematic representation, the control flows and of data of the 7 modules that conform it are shown. For each module the functions are described and it presents an image of the corresponding interface. With the SADR its can be carried out the one registration and the upgrade of the inventory of radioactive waste, the planning of those disqualification operations, the annual consolidation of the volumes of waste generated and disqualified, the evaluation of specific and general indicators and the one tendencies analysis. The handling of the system through the intranet allows the enter of data from the operations place with the radioactive wastes. The results of the operation of the SADR show the utility of this work to elevate the efficiency of the administration of the radioactive wastes. (Author)

Evaluation of the quality of the radiopharmaceutical 99mTc-MIBI and its influence on image quality in myocardial perfusion scintigraphy; Avaliacao da qualidade do radiofarmaco {sup 99m}Tc-MIBI e sua influencia na qualidade da imagem em cintilografia de perfusao do miocardio

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Santos, Poliane Angelo de Lucena

2013-07-01

This study evaluated the quality of the {sup 99m}Tc-MIBI radiopharmaceutical from different manufacturers, used in three nuclear medicine services (NMS) in Recife-PE, through labeling procedure of each service. It was observed their biodistribution by quantifying the activity present in the organs of interest (heart / liver), the influence and interference in image quality and in myocardial scintigraphy diagnosis exam. In these NMS (A, B and C) were done quality controls in the eluates of {sup 99}Mo/{sup 99m}Tc generators (radionuclidic, chemical and radiochemical purity and pH) and of the {sup 99m}Tc-MIBI radiopharmaceutical (radiochemical purity and pH) used in myocardial scintigraphy exam. In the case of radiochemical purity (RCP), was used the thin layer chromatography technique; after the chromatographic ran on, the plates were analyzed both in the dose calibrator, and in scintillation camera of each NMS. The radiopharmaceutical biodistribution was evaluated through the activities present in the heart and liver images in 60 patients, using the technique of combined images counting. Five nuclear physicians analyzed 24 images through myocardial perfusion visual interpretation during stress, it was verified the agreement degree among them. The results of the quality control showed that all eluate samples were in agreement with the manufacturers in relation to radionuclidic purity and pH. In relation to chemical purity, 10% of the services samples B and C showed Al{sup +3} values above 10 ppm. In the RCP, it was observed that using the scintillation camera, only 22% of the samples would be discarded, while with dose calibrator would be 78%, indicating that the scintillation camera is more sensitive in chromatographic pale analysis. For the labeled radiopharmaceutical, the services B and C presented respectively one and three samples with RCP percentage below 90%. However, C service presented the lowest medium to liver/heart proportions, showing that this factor does not depends on the labeling efficiency. In the images evaluation, in relation to perfusion defect degree, were observed a lower concordance number (20%) among the evaluators in the exams group with radiopharmaceutical labeling problems. These results suggested that problems in radiopharmaceutical labeling can interfere in image interpretation, emphasizing the need to comply with ANVISA (Brazilian Health Surveillance Agency) requirements in relation to quality controls in radiopharmaceuticals implementation before its administration to the patient. (author)

Biodistribution of the radiopharmaceutical sodium pertechnetate (Na{sup 99m}TcO{sub 4}) after massive small bowel resection in rats; Biodistribuicao do radiofarmaco pertecnetato de sodio (Na{sup 99m}TcO{sub 4}) em ratos submetidos a resseccao extensa de intestino delgado

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Chacon, Damaso de Araujo; Araujo-Filho, Irami; Villarim-Neto, Arthur; Brandao-Neto, Jose; Medeiros, Aldo Cunha [Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN (Brazil). Programa de Pos-graduacao em Ciencias da Saude]. E-mail: damasochacon@uol.com.br; Rego, Amalia Cinthia Meneses [Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN (Brazil). Programa de Iniciacao Cientifica; Azevedo, Italo Medeiros [Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN (Brazil). Dept. de Cirurgia; Bernardo-Filho, Mario [Universidade do Estado, Rio de Janeiro, RJ (Brazil). Dept. de Biofisica e Biometria

2007-11-15

Purpose: To evaluate the biodistribution of sodium pertechnetate (Na{sup 99m}TcO{sub 4}) in organs and tissues, the morphometry of remnant intestinal mucosa and ponderal evolution in rats subjected to massive resection of the small intestine. Methods:Twenty-one Wistar rats were randomly divided into three groups of 7 animals each. The short bowel (SB) group was subjected to massive resection of the small intestine; the control group (C) rats were not operated on, and soft intestinal handling was performed in sham rats. The animals were weighed weekly. On the 30th postoperative day, 0.1 mL of Na{sup 99m}TcO{sub 4}, with mean activity of 0.66 MBq was injected intravenously into the orbital plexus. After 30 minutes, the rats were killed with an overdose of anesthetic, and fragments of the liver, spleen, pancreas, stomach, duodenum, small intestine, thyroid, lung, heart, kidney, bladder, muscle, femur and brain were harvested. The biopsies were washed with 0.9% NaCl.,The radioactivity was counted using Gamma Counter Wizard{sup TM} 1470, Perkin-Elmer. The percentage of radioactivity per gram of tissue (%ATI/g) was calculated. Biopsies of the remaining jejunum were analysed by HE staining to obtain mucosal thickness. Analysis of variance (ANOVA) and the Tukey test for multiple comparisons were used, considering p<0.05 as significant. Results: There were no significant differences in %ATI/g of the Na{sup 99m}TcO{sub 4} in the organs of the groups studied (p>0.05). An increase in the weight of the SB rats was observed after the second postoperative week. The jejunal mucosal thickness of the SB rats was significantly greater than that of C and sham rats (p<0.05). Conclusion: In rats with experimentally-produced short bowel syndrome, an adaptive response by the intestinal mucosa reduced weight loss. The biodistribution of Na{sup 99m}TcO{sub 4} was not affected by massive intestinal resection, suggesting that short bowel syndrome is not the cause of misleading interpretation, if an examination using this radiopharmaceutical is indicated. (author)

Use of a 10-Channel Linear Scanner in the Differential Diagnosis of Arterial Hypertension; Empleo de un Centelleografo Lineal de Diez Canales en el Diagnostico Diferencial de la Hipertension Arterial

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Cuaron, A.; Ortiz-Quezada, F.; Gordon, F.; Trevino, H. [Hospital General del Centro Medico Nacional, IMSS, Mexico D.F. (Mexico)

1969-05-15

ischaemia. The authors believe that in the study of arterial hypertension scintigraphic scanning should be carried out in conjunction with the plot of a curve showing renal concentration of chlormerodrin. This is to avoid possible errors due to differences in geometry of the two kidneys in relation to the detector. (author) [Spanish] Durante mucho tiempo se ha reconocido la necesidad de una prueba clinica sencilla que permita seleccionar a los pacientes cuya hipertension arterial tenga un origen renovascular. Durante el ultimo ano hemos empleado un centelleografo lineal con diez detectores en paralelo, para la delineacion de las lesiones localizadas en el rinon y para la estimacion de la velocidad de la concentracion renal de la cloromerodrina marcada con {sup 203}Hg. Este centelleografo nos permite obtener imagenes renales muy satisfactorias en 263 min, despues de la administracion endovenosa de 100 a 250 {mu}Ci del radiofarmaco. Despues de la administracion del compuesto radiactivo se obtuvieron imagenes centelleograficas de ambos rinones a los 5, 10, 20, 30, 40, 50 y 60 min, sin suprimir la radiactividad de fondo. Todos los datos fueron registrados en una cinta magnetica para posteriormente seleccionar los factores tecnicos necesarios para reproducir una imagen con cualidades optimas de contraste e intensidad. El integrador de pulsos, incluido en el instrumento, fue empleado para estimar la radiactividad en cada uno de los rinones durante cada exploracion centelleografica. Los resultados fueron expresados como la relacion de la radiactividad renal a un tiempo dado (C{sub t}) sobre la radiactividad renal a los 5 min (C{sub 5}), (C{sub t}/C{sub 5}); este valor fue denominado indice de la concentracion renal (ICR). Para diferenciar la isquemia renal bilateral de la hipertension arterial esencial, el ICR del rinon derecho (RD) fue dividido por el ICR del rinon izquierdo (RI), obteniendose un indice de comparacion entre ambos rinones (comp. I). Se concluye que el

Development of a specific radiopharmaceutical based on gold nanoparticles functionalized with HYNIC-peptide/mannose for the sentinel lymph node detection in breast cancer; Desarrollo de un radiofarmaco especifico basado en nanoparticulas de oro funcionalizadas con HYNIC-peptido/manosa para la deteccion de ganglio centinela en cancer de mama

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Ocampo G, B. E.

2012-07-01

The aim of this research was to prepare a multifunctional system of {sup 99m}Tc-labelled gold nanoparticles conjugated to HYNIC-G GC/mannose and to evaluate its biological behaviour as a potential radiopharmaceutical for sentinel lymph node detection. Hydrazino nicotinyl-Gly-Gly-Cys-NH{sub 2} (HYNIC-G GC) peptide and a thiol-triazole-mannose derivative were synthesized, characterized and conjugated to gold nanoparticles (Au-Np, 20 nm) to prepare a multifunctional system of HYNIC-G GC-Au-Np-mannose by means of spontaneous reaction of the thiol (Cys) present in HYNIC-G GC sequence and in the thiol-mannose derivative. The nano conjugate was characterized by transmission electron microscopy (Tem), IR, UV-Vis, Raman, Fluorescence and X-ray photoelectron spectroscopy (XP S). {sup 99m}Tc labelling was carried out using EDDA/tricine as co ligands and SnCl{sub 2} as reducing agent with further size-exclusion chromatography purification. Radiochemical purity was determined by size-exclusion HPLC and I TLC-Sg analyses. In vitro binding studies were carried out in rat liver homogenized tissue (mannose-receptor positive tissue). Biodistribution studies were accomplished in Wistar rats and images obtained using a micro-SPECT/CT system. Tem and the spectroscopic techniques demonstrated that Au-Np were functionalized with HYNIC-G GC and thiol-mannose through interactions with thiol groups of cysteine. Radio-chromatograms showed radiochemical purity higher than 95%. {sup 99m}Tc-EDDA/HYNIC-G GC-Au-Np-mannose ({sup 99m}Tc-Au-Np-mannose) showed specific recognition for mannose receptors in rat liver tissue. After subcutaneous administration of {sup 99m}Tc-Au-Np-mannose in rats (foot pad), radioactivity levels in the popliteal and inguinal lymph nodes revealed that 99% of the activity was extracted by the first lymph node (popliteal extraction). Biodistribution studies and in vivo micro-SPECT/CT images in Wistar rats showed an evident lymph node uptake (11.58 {+-} 1.98% Id at 1 h) which was retained during 24 h with minimal kidney accumulation (0.98 {+-} 0.10% Id) and negligible uptake in all other tissues. In order to design a pharmaceutical formulation for the instant preparation of stable m ultimeric systems with target-specific molecular recognition based on gold nanoparticles, a freeze-dried kit formulation of {sup 99m}Tc-ethylenediamine-N, N-diacetic acid (EDDA)/hydrazino nicotinyl (HYNIC)-Tyr{sup 3}-octreotide ({sup 99m}Tc-EDDA/HYNIC-TOC, previously approved by the Mexican Ministry of Health) (vial 1) and a second vial containing 1.5 ml of Au-Np solution plus 10 {mu}L of thiol-mannose, Lys{sup 3}-bombesin, or cyclo[Arg-Gly-Asp-D-Phe-Lys-(Cys)] (c[RGDfK(C)] (approximately 285 molecules per Au-Np) (vial 2) were prepared. M ultimeric radiopharmaceuticals prepared from kit showed a radiochemical purity of 96 {+-} 2%. The far-infrared spectra showed a characteristic band at 279 {+-} 1 cm{sup -1}, which was assigned to the Au-S bond. UV-Vis and XP S also indicated that the Au-Np were functionalized with peptides or mannose. Radiopharmaceuticals showed specific recognition for receptors expressed in cancer cells or rat liver cells. Micro-SPECT/CT images showed clear tumour uptake and lymph node accumulation. The kit demonstrated excellent stability during storage at 4 C for 6 months. This study demonstrated that {sup 99m}Tc-Au-Np-mannose remains within the first lymph node during 24 h and therefore might be useful as a target-specific radiopharmaceutical for SLND using 1-day or 2-day conventional protocols. Likewise, m ultimeric systems of {sup 99m}Tc-Au-Np-mannose, {sup 99m}Tc-Au-Np-RGD and {sup 99m}Tc-Au-Np-Lys{sup 3}-bombesin prepared from kits exhibited properties suitable as target-specific agents for molecular imaging of tumours and sentinel lymph node. (Author)

Design and optimization of the production process of radiopharmaceutical {sup 177}Lu-DOTA-Nal{sup 3}-Octreotide for the treatment of gastro-entero-pancreatic tumors; Diseno y optimizacion del proceso de produccion del radiofarmaco {sup 177}Lu-DOTA-Nal{sup 3}-Octreotido para el tratamiento de tumores gastroenteropancreaticos

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Sanchez G, M. F.

2013-07-01

The radiolabel peptides are molecules of interest in nuclear medicine for their therapeutic and diagnostic application in cancer. Among an impressing group of relevant peptides, those similar of the somatostatin, as the Nal{sup 3}-Octreotide (NOC), have established as potential radiopharmaceuticals when presenting significant affinity for the receptors of this peptide hormone that are over expressed and broadly distributed in tumors of neuroendocrine origin, as the gastro-entero-pancreatic tumors. On the other hand, the Lutetium-177 ({sup 177}Lu) is an ideal candidate for the peptides radiolabel and has favorable characteristics to be used in radionuclide therapy. The objective of this work was designing, optimizing and to document the production process of the radiopharmaceutical {sup 177}Lu-DOTA-Nal{sup 3}-Octreotide ({sup 177}Lu-DOTANOC) for the solicitude of its sanitary registration before the Comision Federal contra Riesgos Sanitarios (COFEPRIS). For the optimization of the production process a factorial design of three variables was evaluated with mixed levels (18 combinations), where the dependent variable is the radiochemical purity and the analytic method used to determine this parameter (High Performance Liquid Chromatography) was validated. Later on, by means of the production of 3 lots of the optimized formula of the radiopharmaceutical {sup 177}Lu-DOTANOC the production process was validated and the stability long term study to determine the period of useful life was carried out. The following pharmaceutical formulation was adopted as good: 1.85 GBq (0.5μg) of {sup 177}Lu, 250 μg of DOTANOC and 150 μL of acetates Buffer 1 M ph 5 in 5 m L of the medium. The analytic method used to determine the radiochemical purity of the formulation satisfied the requirements for the wished analytic application. We can conclude that the 3 validation lots prepared under protocols of Good Production Practices, in the Plant of Radiopharmaceuticals Production of the Instituto Nacional de Investigaciones Nucleares (ININ), they fulfill the pre established specifications when is obtained a sterile and free formulation of bacterial endotoxins with yields of labeled of 100% and that conserves their quality characteristics during at least 8 days. Finally, the legal file of the {sup 177}Lu-DOTANOC was integrated with the documented evidence of the quality, security and effectiveness of a formulation of this radiopharmaceutical that is stable the enough time for their distribution and use in the treatment of gastro-entero-pancreatic tumors. (Author)

Optimization of the production process of a lyophilized formulation for radiopharmaceutical obtaining {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]{sub 2}; Optimizacion del proceso de fabricacion de una formulacion liofilizada para la obtencion del radiofarmaco {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]{sub 2}

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Sanchez R, S.

2013-07-01

In this work was optimized the production process of a lyophilized pharmaceutical formulation for the preparation of radiopharmaceutical {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]{sub 2}, the union specifies to the integrin s α{sub v}β{sub 3} was demonstrated to be used in the nuclear medicine cabinets in the obtaining of scan images for the opportune detection of breast cancer. The good lyophilized pharmaceutical formulation for the preparation of radiopharmaceutical {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]{sub 2} was established like: HYNIC-E-[c(RGDfK)]{sub 2} - 25 μg; Stannous chloride (SnCl{sub 2}) 20 μg; Ethylenediamine diacetic acid (EDDA) 10 mg; N-tris(hydroxymethyl)methyl glycin (Tricine) 20 mg; Mannitol 50 mg. The results of radiochemical purity of the sterile formulation and free of bacterial endotoxins for the three validation lots prepared under protocols of good manufacturing practices were 97.62 ± 1.48%, 96.54 ± 1.89%, and 97.66 ± 0.57%, for what the production procedure complies the predefined specifications. The radiopharmaceutical {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]2 prepared from the lyophilized pharmaceutical formulation showed to be stable during a period 24 hours, for what can be used in the centers of molecular nuclear medicine. Images in vivo were obtained of the integrin s over-expression α{sub v}β{sub 3} from the radiopharmaceutical {sup 99m}Tc-EDDA/HYNIC-E-[c(RGDfK)]2 obtained of the lyophilized and optimized pharmaceutical formulation. The lyophilized pharmaceutical formulation (HYNIC-RGD-Sn) showed stability during 12 months, due to this factor, is requested before the COFEPRIS the radiopharmaceutical expiration for this same period (accession number 123300401A0155). (Author)

Use of thin layer chromatography for the determination of radiochemical purity of radiopharmaceuticals in nuclear medicine services of Paraiba and Rio Grande do Norte, Brazil; Utilizacao da cromatografia em camada delgada para determinacao da pureza radioquimica de radiofarmacos em servicos de medicina nuclear da Paraiba e Rio Grande do Norte, Brasil

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Andrade, W.G.; Santos, P.A.L.; Lima, F.R.A. [Universidade Federal de Pernambuco (UFPE), Recife, PE (Brazil). Programa de Pos-Graduacao em Tecnologia Energetica; Lima, F.F., E-mail: wellington.gandrade@gmail.com [Centro Regional de Ciencias Nucleares do Nordeste (CRCN-NE/CNEN-PE), Recife, PE (Brazil)

2012-07-01

The paper chromatography and the thin layer chromatography are separation techniques in which the radioactive components migrate because of their affinity with the eluent (mobile phase) or stationary phase, respectively. In radiopharmaceuticals labeled with {sup 99m}Tc, besides its own radiopharmaceutical, {sup 99m}TcO{sup 4-} free and TcO{sub 2} can be identified and quantified. The evaluation of radiochemical purity of radiopharmaceuticals is essential to produce images free of artifacts as well as avoid unnecessary absorbed dose to the patient. Once they are managed in humans it is important and necessary that they undergo to strict quality control. Because of this, ANVISA in its 'Resolucao da Diretoria Colegiada (RDC) 38 of June 4th, 2008 states the obligation of performing a minimum of tests in nuclear medicine services routine prior to human administration. This work evaluated, by the method of thin layer chromatography (TLC), radiochemical purity, determined the pH of the radiopharmaceutical DEXTRAN- 500, DMSA, DTPA, PHYTATE, MDP, MIBI and Sn-Col used in nuclear medicine services in the states of Paraiba and Rio Grande do Norte - Brazil. The results show that the use of thin layer chromatography (TLC) as a standard method in routine of nuclear medicine services is possible, because it provides important data for the evaluation of radiochemical purity, allowing the exclusion of a radiopharmaceutical poorly marked. (author)

Development of a lyophilized formulation for preparing the radiopharmaceutical {sup 68}Ga-DOTA-Nal{sup 3}-Octreotide for the diagnosis of tumors of neuroendocrine origin; Desarrollo de una formulacion liofiizada para la preparacion del radiofarmaco {sup 68}Ga-DOTA-Nal{sup 3}-Octreotido para el diagnostico de tumores de origen neuroendocrino

Energy Technology Data Exchange (ETDEWEB)

Lorenzo L, G. A.

2015-07-01

The present study aimed to develop a radiopharmaceutical consisting of an emitter positrons radionuclide ({sup 68}Ga) which is used in imaging by positron emission tomography; and a peptide capable of binding to somatostatin receptors subtypes 2, 3 and 5; which together serve as a diagnostic support of tumors of neuroendocrine origin. The peptide characterization DOTA-1-Naphthylalanine{sup 3}-Octreotide (DOTA-NOC) by infrared spectroscopy technique by Fourier transform was performed, in which the principal functional groups belonging to this molecule were identified as well as its identification by UV-Vis spectroscopy. Subsequently, a variance analysis taking into account three different levels of amounts of sodium acetate, and three different levels of amounts of the peptide was performed. These masses were subjected to lyophilization for a period of 21 h; after completion of lyophilization, were labeled with 2 m L of {sup 68}GaCl{sub 3} eluates of a {sup 68}Ge/{sup 68}Ga ITG generator to determine the percentage of radiochemical purity of the different formulations. It was observed that the ideal formulation must contain 75 μg of peptide and 14 mg of NaOAc, according to studies, was determined that the amount of peptide does not influence the response of radiochemical purity in the same way that the amount of added sodium acetate, which produces different effects on the dependent variable. Finally the radiopharmaceutical formulation was obtained with greater than 95% of radiochemical purity. The validation of the analytical method was performed describing the system accuracy and linearity, specificity and accuracy; linearity and precision of the method, taking into account acceptance criteria based on the guidance of validation of analytical methods published by the National Association of Pharmacists Chemical Biologists of Mexico, A. C.; the parameters evaluated met the specifications given by the guide validation of analytical methods. Uptake and internalization tests of the radiopharmaceutical in AR42J cells were performed, obtaining significant differences in both tests, indicating affinity of the radiopharmaceutical by cells, because they exhibit over expression of SST R2 and 5 receptors. The report of the validation of the production process of the formulation was issued based on the established of the NOM-241-SSA1-2012. (Author)

Biodistribution dosimetric study of radiopharmaceutical {sup 99mT}c Ixolaris in mice for melanoma diagnosis by molecular image and translational model for human beings; Estudo dosimetrico da biodistribuicao do radiofarmaco Ixolaris-{sup 99m}Tc em camundongos para diagnostico de melanoma atraves de imagem molecular e modelo translacional para humanos

Energy Technology Data Exchange (ETDEWEB)

Soriano, Sarah Canuto Silva

2015-07-01

The labeling of Ixolaris with {sup 99m}Tc was developed by Barboza et.al. (2013) aiming its use primarily in glioblastoma and after in melanoma diagnosis, a less common but very aggressive cancer and with high mortality rate. Preliminary tests on animals have proven its effectiveness of labeling but a dosimetric study to human clinical trials should be performed. This study aimed to: (1) determine the biokinetic model for the radiotracer {sup 99m}Tc-Ixolaris in mice by imaging dosimetry method; and (2) estimate the absorbed and effective dose resulting from the use of a new radiopharmaceutical for melanoma and metastases diagnosis in human beings, since a dosimetric study of new radiopharmaceuticals in animals is necessary to test them subsequently in humans and apply for registration in ANVISA. According to SPECT images, was found a latency period of 15 to 21 days for the development of lung metastasis in mice. Three C57BL6 mice, one control animal, and two animals with induced cell line B16-F10 murine melanoma were tested. The {sup 99m}Tc-Ixolaris radiopharmaceutical was administered intravenously in a caudal vein, and SPECT images were acquired 0.5 h, 1.5 h, 2.5 h, 3.5 h and 24 h post-administration for analysis and biodistribution quantification. The biokinetic model was determined and thus, obtained cumulative activity in order to estimate the absorbed dose in each organ. The mass and metabolic differences between mice and humans were considered and used to extrapolate the data acquired at different scales. Based on dose factors provided by the software MIRDOSE and Olinda (S factor), absorbed doses in irradiated target organs were calculated for the source organs, and finally the effective dose was estimated. The results indicate that for diagnostic exams conducted in human melanoma patients by administering approximately 25.7 MBq the estimated effective dose was 4.3 mSv. Comparing with effective doses obtained in other diagnostic techniques with {sup 99m}Tc, a range of effective doses from 0.6 to 4.8 mSv, it was concluded that the procedure should proceed continue into a Clinical Phase in humans. (author)

Synthesis and evaluation in vitro in cancer cells AR42J of the radiopharmaceutical {sup 99m}Tc-Tyr{sup 3}-Octreotide-dendrimer similar of somatostatin; Sintesis y evaluacion in vitro en celulas de cancer AR42J del radiofarmaco {sup 99m}Tc-Tyr{sup 3}-Octreotido-dendrimero analogo de la somatostatina

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Orocio R, E.

2013-07-01

The objective of this project was preparing a multimeric system through the conjugation of several molecules of the peptide Tyr{sup 3}-Octreotide to a dendrimer molecule based on Poly-amidoamine (PAMAM), as well as radiolabeled with {sup 99m}Tc and evaluating its behavior like new radiopharmaceutical similar of somatostatin. The dendrimer PAMAM generation 3.5 that possesses terminal groups of sodium carboxylate, was functionalized to peptide Tyr{sup 3}-Octreotide through a reaction of peptide coupling with HATU (hexafluorophosphate (V) of 1-oxide-3-(bis(dimethylamino)methylene)-3H-[1,2,3]triazole[4,5-b]pyridine) as activating agent of carboxylate groups using the Size Exclusion Chromatography (Sec) as purification method. The product was characterized by Ultraviolet visible spectrophotometry, Mid-infrared and Far-infrared, Elemental analysis, Energy dispersive X-ray spectroscopy, Scanning electron microscopy, Thermogravimetry and Differential scanning calorimetry. The radiolabeled with {sup 99m}Tc was carried out using a direct method that involves the reduction of the anion TcO{sub 4}{sup -} with stannous chloride, so that the dendrimer is capable of coordinating to the technetium forming a chelate compound. The radiochemical purity of the radiolabeled compound was determined by thin layer chromatography using a sodium chloride solution to 20% (m/v) as mobile phase and was verified by molecular exclusion chromatography. The radiolabeled compound was possible to obtain it with a radiochemical purity superior to 90%. Also, the specific and not specific union was evaluated of the synthesized compound in mouse pancreas cancer cells AR42J, positive to somatostatin receptors, showing specific recognition for this receptors type with high cellular internalization. The biodistribution studies were carried out in BALB/c mice at different post injection times and in nude mice with induced tumors AR42J. The results showed that the {sup 99m}Tc-PAMAM-Tyr{sup 3}-Octreotide is excreted by via renal as hepatobiliary with a tumor capture of 4.12±0.6 D.I.g{sup -1} at the two hours of having been administered, which shows their potential as new radiopharmaceutical similar of somatostatin for the tumors detection of neuroendocrine origin. (Author)

Evaluation of the cell death mechanisms activated by the radiopharmaceutical {sup 177}Lu-DOTA-anti-CD20 in a dose range of 1 to 5 Gy; Evaluacion de los mecanismos de muerte celular activados por el radiofarmaco {sup 177}Lu-DOTA-anti-CD20 en un intervalo de dosis de 1 a 5 Gy

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Azorin V, E.P.; Rojas C, E. L.; Martinez V, B. E.; Ramos B, J. C.; Jimenez M, N. P.; Ferro F, G., E-mail: erica.azorin@inin.gob.mx [ININ, Carretera Mexico-Toluca s/n, 52750 Ocoyoacac, Estado de Mexico (Mexico)

2016-10-15

The radio immunotherapy with anti-CD20 antibodies significantly increases the remission rate of patients with B-cell lymphomas over expressing the CD20. The radiolabeled antibodies directed to surface antigens allow delivering scaled doses of radiation to specific targets thus limiting the dose to healthy tissue. The anti-CD20 causes cell death by two major pathways; activating the immune system to destroy malignant cells and inducing the activation of cell death pathways. The {sup 177}Lu is a beta particle emitter (max. 0.497 MeV) with a maximum reach on soft tissue of 0.7 mm and a half-life of 6.7 days. Several clinical studies have established a maximum tolerated dose (45 m Ci/m{sup 2}) for {sup 177}Lu-DOTA-rituximab, which shows a favorable clinical response without hematological toxicity. However, the molecular mechanisms of action by synergistic effect of anti-CD20 and radionuclide have not been studied. In this work was evaluated; by flow cytometry, the activation kinetics of the cell death mechanisms induced by the treatment with {sup 177}Lu-DOTA-Anti-CD20 in non-Hodgkin (Raji) lymphoma cells. The absorbed radiation dose delivered to the cell nucleus was calculated by Monte Carlo simulation, considering the contribution of the beta emissions of the radiopharmaceutical present in the cell membrane and surrounding environment, as well as crossfire. This work shows that the application of radiation doses of 1 to 5 Gy of the radiopharmaceutical {sup 177}Lu-DOTA-anti-CD20, are sufficient to induce cell death by apoptosis and arrest of the cell cycle. The combination of these factors (continuous delivery of radiation, activation of repair mechanisms and increased radio sensitivity) causes the acute activation of the apoptotic program resulting in significant cell death after 96 h of treatment. The temporal analysis of cell death suggests the early activation of apoptosis that is counteracted by the activation of repair processes caused by sustained irradiation, which leads to cell arrest and increases cytotoxicity, thus favoring the sudden activation of apoptosis after several days of treatment. (Author)

Quality assurance system in the production process of the gamma shielding devices used for transport and handling of radiopharmaceuticals and labelled compounds at Cuba; Sistema de aseguramiento de la calidad en el proceso de produccion de los dispositivos de blindaje gamma utilizados en el transporte y manipulacion de los radiofarmacos y compuestos marcados en Cuba

Energy Technology Data Exchange (ETDEWEB)

Zuniga Santa, Juan F.; Fernandez Rondon, Manuel; Viante Garrido, Enrique; Berdeguez, Mirta B.T. [Centro de Tecnologia Nuclear (CTN), La Habana (Cuba); Rodriguez Perez, Hilario [Instituto Superior Politecnico Jose Antonio Echeverria (ISPJAE), La Habana (Cuba)

1999-11-01

The paper shows how a Quality Assurance System for the process of production of gamma shielding devices has been conceived, designed and implemented. Special emphasis is given to the necessity of utilizing tools of control statistic in order to guaranteed the quality in the serial production process of such devices used in the transport, storage and handling of radioactive materials.(author) 14 refs., 4 figs., 4 tabs.; e-mail: ctn at ctnet.centis.edu.cu; bada at cujae.ispjae.edu.cu

Standardization of {sup 123}I and {sup 18}F for providing traceability of activity meters performed in the Radiopharmaceutical Production Service of the Instituto de Engenharia Nuclear, RJ, Brazil; Padronizacao do Iodo-123 e Fluor-18 para provimento de rastreabilidade das medicoes de atividade realizadas no Servico de Producao de Radiofarmacos do Instituto de Engenharia Nuclear

Energy Technology Data Exchange (ETDEWEB)

Andrade, E.A.L., E-mail: erica@ien.gov.br [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil); Delgado, J.U.; Iwahara, A.; Contic, C.C., E-mail: delgado@ird.gov.br, E-mail: iwahara@ird.gov.br, E-mail: ccconti@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 Sanitary Vigilance National Agency which requiring Good Manufacturing Practices certification for all segments within the Nuclear Medicine. Quality Assurance Programmes should implement the standard requirements to ensure that radiopharmaceuticals have requirements quality to proving its efficiency. Several aspects should be controlled, and one of them is the traceability of the Radionuclides Activity Measurement in radiopharmaceuticals doses. This paper aims to provide traceability to dose calibrators (well type ionization chambers) used for {sup 123}I and {sup 18}F activity measurements in Radiopharmaceuticals Production Service placed in Institute of Nuclear Engineering, Rio de Janeiro, RJ, Brazil. (author)

Development of a lyophilized formulation for the preparation of radiopharmaceutical {sup 68}Ga-DOTA-E-[c(RGDfK)]{sub 2} for the diagnosis of breast cancer tumors; Desarrollo de una formulacion liofilizada para la preparacion del radiofarmaco {sup 68}Ga-DOTA-E-[c(RGDfK)]{sub 2} para el diagnostico de tumores de cancer de mama

Energy Technology Data Exchange (ETDEWEB)

Terron A, E. J.

2015-07-01

Radiopharmaceuticals of third generation by its design that includes peptides capable of selectively directing the radiation to a specific molecular target are useful in molecular medicine for obtaining molecular images that allow recording in vivo phenomena temporal-space of molecular or cellular processes, with diagnostic or therapeutic applications. Generally, peptides that recognize cellular receptors that are over-expressed in cancer cells of interest are used; such is the case of RGD (arginine-glycine-aspartic acid) a tri-peptide sequence which recognizes to the membrane receptors α(v)β(3) and α(v)β(5) that are involved in metastasis and angiogenic processes as well as in tumor cells of breast glioma. The high affinity and selectivity of RGD peptide with integrin s α(v)β(3) and α(v)β(5) is the basis for designing radiopharmaceuticals for diagnostic of breast cancer and the metastasis and angiogenic processes. In this paper a useful lyophilized formulation was development for obtaining {sup 68}Ga-DOTA-E-[c(RGDfK)]{sub 2} radiopharmaceutical that for its effectiveness, stability and security can be used in humans. The production process of core-equipment DOTA-E-[c(RGDfK]{sub 2}/Buffer sodium acetate 1.0 M was optimized, and the formulation was transferred to the radiopharmaceuticals production plant of the Instituto Nacional de Investigaciones Nucleares (ININ). The optimized formulation of the core-equipment for the {sup 68}Ga-DOTA-E-[c(RGDfK)]{sub 2} radiopharmaceutical preparation is: DOTA-E-[c(RGDfK)]{sub 2} peptide - 75 μg; Mannitol - 50 mg; Sodium acetate - 14 mg; Sodium acetate buffer 1.0 M ph 4.3 - 0.5 m L. The production process was validated and stability studies were carried out to the validation batches in compliance with the validation master plan of the ININ and in adherence to compliance of the applicable national and international regulations. Also the legal dossier was drawn up in order to make the application of sanitary registration before Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS). (Author)

Evaluation of cell death mechanisms activated by the administration of the theranostics radiopharmaceutical {sup 177}Lu-DOTA-anti-CD20 in a dose range of 1-5 Gy; Evaluacion de los mecanismos de muerte celular activados por la administracion del radiofarmaco teranostico {sup 177}Lu-DOTA-anti-CD20 en un rango de dosis de 1-5 Gy

Energy Technology Data Exchange (ETDEWEB)

Martinez V, B. E.

2016-07-01

Radio-immunotherapy with anti-CD20 antibodies significantly increases the rate of remission in patients with CD20 over expressing B-cell lymphomas. Radio-labeled antibodies directed to surface antigens allow delivering scaled doses of radiation to specific targets thus limiting the dose to healthy tissue. Anti-CD20 causes cell death by two major pathways; activating the immune system to destroy malignant cells and inducing the activation of cell death pathways. The {sup 177}Lu is a beta particle emitter (max. 0.497 MeV) with a maximum soft tissue reach of 0.7 mm and a half-life of 6.7 days. Several clinical studies have established a maximum tolerated dose (45m Ci/m{sup 2}) for {sup 177}Lu-DOTA-rituximab, which shows a favorable clinical response without hematological toxicity. However, the molecular mechanisms of synergistic activation of anti-CD20 and radionuclide have not been studied. In this work we evaluated by flow cytometry, the activation kinetics of the cell death mechanisms induced by the treatment with {sup 177}Lu-DOTA-anti-CD20 from non-Hod king lymphoma cells (Raji). The absorbed radiation dose delivered to the cell nucleus was calculated by Monte Carlo simulation, considering the contribution of the beta emissions of the radiopharmaceutical present in the cell membrane and surrounding environment, as well as crossfire. This work shows that the application of radiation doses of 1 to 5 Gy of the radiopharmaceutical {sup 177}Lu-DOTA-anti-CD20 are sufficient to induce cell death by apoptosis and arrest of the cell cycle. The combination of these factors (continuous delivery of radiation activation of repair mechanisms and increased radio-sensitivity) causes acute activation of the apoptotic program resulting in significant cell death after 96 h of treatment. The temporal analysis of cell death suggests the early activation of apoptosis that is counteracted by the activation of repair processes caused by sustained irradiation, which leads to cell arrest and increases cytotoxicity, thus favoring the sudden activation of apoptosis after several days of treatment. (Author)

Evaluation of the internalization kinetics of the radiopharmaceutical {sup 99m}Tc-N{sub 2}S{sub 2}-Tat(49-57)Lys{sup 3}-Bn with diagnostic purposes, using comet assay; Evaluacion de la cinetica de internalizacion del radiofarmaco {sup 99m}Tc-N{sub 2}S{sub 2}-TAT(49-57)Lys{sup 3}-BN con fines diagnosticos, empleando ensayo cometa

Energy Technology Data Exchange (ETDEWEB)

Luna G, M. A.

2011-07-01

Gastrin-rea leasing peptide receptors (GRP-r) are over expressed in breast and prostate cancer cells. Bombesin (Bn) binds specifically and strongly to GRP-r and this is the base for to label the Bn with radionuclides by gamma rays. Tat (49-57) is a peptide that across the cell membrane easily so that, when it is conjugated to different proteins, it can works as a Trojan horse, facilitating the drug internalization to the cells. The radiopharmaceutical {sup 99m}Tc-N{sub 2}S{sub 2}-Tat(49-57)-Lys{sup 3}-Bn was prepared for diagnosis and therapy at early stage of breast cancer. The objective of this study was to determine the role of Tat in the internalization kinetics of radiopharmaceuticals measured by DNA damage induced by means of comet assay. Human lymphocytes were treated with the following protocols: a) Tat-Bn, b) {sup 99m}Tc-Bn, or c) {sup 99m}Tc-N{sub 2}S{sub 2}-Tat(49-57)-Lys{sup 3}-Bn, also an untreated group was conformed. The internalization was evaluated at 0, 5, 10, 15, 30 and 60 min after exposure with three repetitions each one, and for radiopharmaceuticals with 2.9, 6.6, 9.0 and 14.8 MBq activities. DNA damage was scored in 100 cells per time and treatment, as tail length and tail moment. A Kruskal-Wallis variance analysis with p{<=} 0.05 was applied for comparison between treatments. The results showed that the damage caused by {sup 99m}Tc-N{sub 2}S{sub 2}-Tat(49-57)-Lys{sup 3}-Bn is significantly higher than that caused by {sup 99m}Tc-Bn and Tat-Bn, showing that Tat favors the internalization of the radiopharmaceutical. (Author)

Radiation protection of patients in medical exposures: regional project IAEA 2007-2008 RLA/9/57;Proteccion radiologica de pacientes en exposiciones medicas: proyecto regional IAEA 2007-2008 RLA/9/57

Energy Technology Data Exchange (ETDEWEB)

NONE

2007-07-01

primarios simples con resultados rapidos, involucramiento de los medicos, compromiso institucional al ver resultados posteriores a etapas mas complejas, rigidez tecnica, sostenibilidad. Entre las metas de los estados miembros estan: evitar radiolesiones en procedimientos intervencionistas y reducir la probabilidad de efectos estocasticos, especialmente en pediatria; reduccion de dosis cambiando a tierras raras en paises que aun no lo han hecho, optimizacion en mamografia, optimizacion de la proteccion en TAC, con enfasis en pediatria; proteccion de familiares y del publico al dar de alta al paciente, despues de una terapia con radiofarmacos; evitar exposiciones accidentales en radioterapia y radiologia pediatrica. El contenido esta dividido en cuatro partes que incluyen diferentes formularios para recopilar informacion constituidos en los siguientes temas: Intervencion, con informacion sobre Incertidumbres en la calibracion del medidor de P{sub K}A, Evaluacion de dosis con pelicula radiocromica, Datos de procesamientos y proteccion radiologica, Mediciones de producto kerma-area, Practica: Valoracion de la exposicion del paciente en radiologia intervencionista, Determinacion de la capa Hemi reductora, Recalibracion y uso de un medidor del producto kerma - area (Pk, a); El tema Mamografia contiene: Aplicacion y criterios de calidad de la imagen: estudio de la mamografia - craneo caudal, Hoja para la captura de datos en pacientes CC y MLO, Hojas para la captura de datos en las practicas de mamografia, incluye descripcion del equipo, determinacion de rendimientos, de espesor Hemi reductor, determinacion de {sup c,} datos de la paciente y dosis glandular; El tema Tomografia contiene: Datos generales de servicios de tomografia computada en el Hospital Max Peralta que incluye reporte de examenes y dosimetria en fantoma, en aire, informacion de scaners usados; El tema Radiologia contiene: Dosimetria de pacientes en radiologia general donde muestra formularios para la determinacion

Radiation protection of patients in medical exposures: regional project IAEA 2007-2008 RLA/9/57; Proteccion radiologica de pacientes en exposiciones medicas: proyecto regional IAEA 2007-2008 RLA/9/57

Energy Technology Data Exchange (ETDEWEB)

NONE

2007-07-01

primarios simples con resultados rapidos, involucramiento de los medicos, compromiso institucional al ver resultados posteriores a etapas mas complejas, rigidez tecnica, sostenibilidad. Entre las metas de los estados miembros estan: evitar radiolesiones en procedimientos intervencionistas y reducir la probabilidad de efectos estocasticos, especialmente en pediatria; reduccion de dosis cambiando a tierras raras en paises que aun no lo han hecho, optimizacion en mamografia, optimizacion de la proteccion en TAC, con enfasis en pediatria; proteccion de familiares y del publico al dar de alta al paciente, despues de una terapia con radiofarmacos; evitar exposiciones accidentales en radioterapia y radiologia pediatrica. El contenido esta dividido en cuatro partes que incluyen diferentes formularios para recopilar informacion constituidos en los siguientes temas: Intervencion, con informacion sobre Incertidumbres en la calibracion del medidor de P{sub K}A, Evaluacion de dosis con pelicula radiocromica, Datos de procesamientos y proteccion radiologica, Mediciones de producto kerma-area, Practica: Valoracion de la exposicion del paciente en radiologia intervencionista, Determinacion de la capa Hemi reductora, Recalibracion y uso de un medidor del producto kerma - area (Pk, a); El tema Mamografia contiene: Aplicacion y criterios de calidad de la imagen: estudio de la mamografia - craneo caudal, Hoja para la captura de datos en pacientes CC y MLO, Hojas para la captura de datos en las practicas de mamografia, incluye descripcion del equipo, determinacion de rendimientos, de espesor Hemi reductor, determinacion de {sup c,} datos de la paciente y dosis glandular; El tema Tomografia contiene: Datos generales de servicios de tomografia computada en el Hospital Max Peralta que incluye reporte de examenes y dosimetria en fantoma, en aire, informacion de scaners usados; El tema Radiologia contiene: Dosimetria de pacientes en radiologia general donde muestra formularios para la determinacion

Detection of myocardial viability by means of Single Proton Emission Computed Tomography (Perfused SPECT) dual {sup 201} Tl (rest of 15 minutes, 24 late hours and 24 hours reinjection) and gated-SPECT {sup 99m} Tc-SESTAMIBI in effort or stimulation of the coronary reserves; Deteccion de viabilidad miocardica mediante tomografia por emision de foton unico (SPECT perfusorio) dual {sup 201} Talio (Reposo de 15 minutos, 24 horas tardio y 24 horas reinyeccion) y gated-SPECT {sup 99m} Tc-SESTAMIBI en esfuerzo o estimulo de reserva coronaria

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Mendoza V, R

2004-07-01

The objective of this work was to determine if the images of SPECT {sup 201} TI in rest of 15 minutes, 24 late hours and Gated-SPECT {sup 99m} Tc-SESTAMIBI in effort or stimulation of coronary reservation correlate with the study of 24 hours post reinjection of {sup 201}TI to determine the presence of having knitted viable myocardium. Material and methods: 29 patients were studied with coronary arterial illness (EAC) to who are carried out SPECT {sup 201} TI in rest with images of 15 minutes, 24 late hours and 24 hours reinjection, by means of the administration of {sup 201}TI to dose of 130 MBq and reinjection with 37 MBq. and Gated-SPECT {sup 99m}Tc-SESTAMIBI in effort or stimulation of coronary reservation, later to the administration of 1110 MBq. Results: 29 patients were included according to inclusion approaches and exclusion, of those which 22 (75.86%) they correspond at the masculine sex and 7 (24.13%) to the feminine one, with an average of 62.1 year-old age, 2320 segments myocardial were analysed so much it is phase post-effort as rest; they were diagnosed a total of 264 segments with heart attack, of which viability myocardium was observed in 174 segments. The statistical tests are analysis of frequencies. The non parametric test of Wilcoxon and Mann-Whitney. Conclusions: the viability myocardial at the 24 late hours and 24 hours reinjection was similar; significant difference exists between the study of 15 minutes and 24 hours reinjection, ischemic illness was also demonstrated in territories different to the heart attack area in the studies of 15 minutes, late 24 hours and 24 hours reinjection. (Author)