RESUMEN
The procedure followed by the Nuclear Metrology Laboratory, at IPEN, for the primary standardization of (99m)Tc is described. The primary standardization has been accomplished by the coincidence method. The beta channel efficiency was varied by electronic discrimination using a software coincidence counting system. Two windows were selected for the gamma channel: one at 140 keV gamma-ray and the other at 20 keV X-ray total absorption peaks. The experimental extrapolation curves were compared with Monte Carlo simulations by means of code ESQUEMA.
Asunto(s)
Radiometría/métodos , Radiometría/normas , Programas Informáticos , Espectrometría gamma/normas , Tecnecio/análisis , Tecnecio/normas , Brasil , Semivida , Internacionalidad , Dosis de Radiación , Estándares de Referencia , Valores de ReferenciaRESUMEN
Intercomparison is an important tool for quality assessment, because equipment performance and procedures are evaluated and compared. In nuclear medicine, this tool is wide utilized to evaluate the ability of the services to measure activities of radiopharmaceuticals which will be administered to the patients in diagnostic or therapeutic procedures. In this work, a comparison program of activity measurements of the 99mTc, 131I, 67Ga and 201Tl radionuclides was established in Pernambuco State, at the Brazilian Northeast, with the aim of evaluating the quality of routine measurements carried out in the NMS. The results in each NMS are sent to the Standard laboratory, which compares these results with the acceptance limits recommended by national regulations. All NMS participants complied with the limit established for the accuracy of measurement (+/-10 percent) and showed that their radionuclide calibrators are adequate for measurement of the activities of radiopharmaceuticals.
A intercomparação é uma importante ferramenta para avaliação da qualidade da medição da atividade de radiofármaco, porque não apenas o desempenho do equipamento é verificado, mas também todo procedimento de medição. Na medicina nuclear, esta ferramenta é amplamente utilizada para avaliar a habilidade dos serviços de medicina nuclear (SMN) na medição da atividade dos radiofármacos que serão administrados aos pacientes para diagnósticos ou procedimentos terapêuticos. Neste trabalho, um programa de intercomparação de medidas de atividades de radiofármacos, utilizando as fontes de 99mTc, 131I, 67Ga e 201Tl, foi estabelecido no estado de Pernambuco, região nordeste do Brasil, com o objetivo de avaliar a qualidade das medições realizadas nos SMN. Os resultados obtidos em cada SMN são enviados ao laboratório padrão, que os compara com os valores de referência recomendados pela norma nacional, verificando o desempenho destes instrumentos. Todos os SMN participantes respeitaram os limites estabelecidos para a exatidão das medidas (+/-10 por cento), demonstrando que os calibradores de radionuclídeos estão adequados/apropriados para a medição de atividades de radiofármacos.
Asunto(s)
Humanos , Control de Calidad , Medicina Nuclear/normas , Radioisótopos de Yodo/normas , Tecnecio/normas , Brasil , Calibración , Estándares de ReferenciaRESUMEN
OBJECTIVE: Exogenous natural surfactant (ENS) labeled with 99mTc shows an elevated lung specificity allowing the acquisition of high-quality images for ventilation scintigraphy. METHODS: The methods for 99mTc-ENS quality control (physical properties, pH determination, radiochemical studies, and biologic studies) were evaluated and validated. RESULTS: The physical properties of the nonradioactive precursor and of the radiopharmaceutical were analyzed as general descriptors of the product. The pH of the radiopharmaceutical was determined by using pH test papers, a method described and validated in the United States Pharmacopeia. Chromatographic studies performed using the acetone/Whatman-1 paper system were validated as a method to evaluate the radiochemical purity of the 99mTc-ENS. Biodistribution studies on rats after intratracheal administration were validated as a method to estimate the radiopharmaceutical biodistribution in humans. CONCLUSION: The proposed method for 99mTc-ENS quality control studies and stability studies was evaluated and validated following international standards.
Asunto(s)
Marcaje Isotópico/métodos , Pulmón/metabolismo , Surfactantes Pulmonares/farmacocinética , Tecnecio/farmacocinética , Animales , Evaluación Preclínica de Medicamentos/métodos , Evaluación Preclínica de Medicamentos/normas , Marcaje Isotópico/normas , Pulmón/diagnóstico por imagen , Tasa de Depuración Metabólica , Especificidad de Órganos , Surfactantes Pulmonares/análisis , Surfactantes Pulmonares/normas , Control de Calidad , Cintigrafía , Radiofármacos/análisis , Radiofármacos/farmacocinética , Radiofármacos/normas , Ratas , Ratas Sprague-Dawley , Tecnecio/análisis , Tecnecio/normas , Distribución TisularRESUMEN
In order to obtain information on the accuracy of activity measurements in Brazilian hospitals, several intercomparison exercises have been organized since 1998. The first exercise consisted of two intercomparison runs of 131I and 99mTc and had the participation of 21 hospitals localized in Rio de Janeiro city and surroundings. The second, with 131I (47 hospitals) and 123I (12 hospitals), had the participation of hospitals localized in the whole country. The results were analyzed under the statistical point of view and conformity to the norms of Regulatory Authority. These results have shown that such exercises are necessary to improve the quality of the measurements and to identify those instruments that are producing incorrect values.
Asunto(s)
Radioisótopos/análisis , Radioisótopos/normas , Radiometría/normas , Brasil , Hospitales , Humanos , Radioisótopos de Yodo/análisis , Radioisótopos de Yodo/normas , Estándares de Referencia , Tecnecio/análisis , Tecnecio/normas , Tecnología RadiológicaRESUMEN
This work outlines the quality assurance program for the activity measurements of the most used radionuclides at Brazilian Nuclear Medicine Services (NMS). The program aims to guarantee that the patient is given the correct prescribed amount of activity in diagnostic or therapeutic applications. This accurate administration depends upon proper use and calibration of the activity meters by the NMS. Underestimation of administered activity in diagnostic practices could delay correct diagnosis disturbing the value of the investigation. On the other hand, the overestimation would be worse, mainly in therapeutic applications, because an unnecessarily high absorbed dose would be delivered to the patient. The preliminary results of intercomparison for 131I and 99mTc showed that many activity meters used at NMS's present problems giving results up to 41% greater than the reference values determined at the National Metrology Laboratory for Ionizing Radiation (LNMRI) which is recognized as the Brazilian authorized metrology laboratory for ionizing radiation. These results have demonstrated that the NMS should improve the accuracy of the activity measurements of the radionuclides administered to the patients and establish the traceability to the national standards of measurements. These standards are based on a pressurized well-type ionization chamber installed at LNMRI and calibrated with reference sources standardized by absolute methods. The protocol of the intercomparison and recommendations made in order to minimize errors in measuring procedures are described and results are discussed.
Asunto(s)
Medicina Nuclear/normas , Radiofármacos/análisis , Radiofármacos/normas , Tecnecio/análisis , Tecnecio/normas , Brasil , Humanos , Control de CalidadRESUMEN
UNLABELLED: Exogenous natural surfactant (ENS) labeled with 99mTc(99mTc-ENS) is a new radiopharmaceutical for pulmonary aerosol scintigraphy. In this study, different freeze-dried formulations were evaluated to develop a suitable and long-storage method for the ENS, the nonradioactive precursor of this radiopharmaceutical. METHODS: Two freeze-dried formulations were evaluated: the sterile ENS suspension-stannous chloride altogether lyophilized (chlorlioENS) and the lyophilized sterile ENS suspension with the addition of stannous chloride as a solid drug (lioENS). These precursors were stored at room temperature for 3 mo and then labeled with 99mTc. For comparative purposes, the sterile ENS suspension with the addition of stannous chloride labeled with 99mTc(99mTc-chlorENS) was also studied. The quality controls for each radiopharmaceutical were performed by an ascending paper chromatography to determine the labeling yield percentages. The study was performed in 30 female Sprague Dawley rats, which inhaled each radiopharmaceutical by nebulization. Twenty-five minutes after the aerosol inhalation, the animals were killed to extract their organs and measure their activity in a gamma spectrometer. The data are given as the percentage of activity concentration (C%) for each organ. RESULTS: The physicochemical properties of lioENS were adequate for a freeze-dried product. The labeling yields for 99mTc-lioENS and for 99mTc-chlorENS were always greater than 95% even after nebulization. The results of the biologic distribution studies showed that the activity concentration found in lungs for these radiopharmaceuticals were 95.7% +/- 2.6% and 96.7% +/- 2.6% respectively, results that do not differ statistically. On the other hand, the activity concentration found in lungs for the 99mTc-chlorlioENS (31.3% +/- 11.1%) and its labeling yield percentages (<10%) are statistically different (P < 0.05) from the results obtained with the two radiopharmaceuticals mentioned above. CONCLUSION: Taking into account the lioENS physicochemical properties, its long shelf life and that 99mTc-lioENS shows the same radiochemical and radiopharmacological behavior of the 99mTc-chlorENS, it can be concluded that the 99mTc-lioENS can be used for aerosol lung scintigraphy.