Proposta de Programa de Garantia da Qualidade para Imagem Molecular Pré-Clínica
Keywords:
Tomografia por Emissão de Pósitron (PET);, Controle de Qualidade (CQ);, NEMAAbstract
Small animal positron emission tomography (PET) is used in molecular studies, generating static and/or dynamic images with functional information of animal organs and tissues, to the development of new radiopharmaceuticals or to new applications of traditional radiopharmaceuticals. The National Electrical Manufactures Association (NEMA) published its NU 4-2008 standards, a consistent set of methodologies for measuring scanner performance parameters for small animal PET imaging. In Brazil, there are six PET devices installed which allows to carry out preclinical PET imaging studies. Therefore, a comprehensive evaluation of the performance of these systems is necessary to ensure the quality of images obtained. In Brazil, there is no recommendation or requirement for the execution of a quality assurance program for these imaging centers from regulators bodies – Nuclear Energy National Commission (CNEN) and Agency for Sanitary Vigilance (ANVISA). The general purpose of this work is to implement a quality assurance program in the Molecular Imaging Laboratory (LIM) of the Nuclear Technology Development Center (CDTN) and propose a national standardization. The work was carried out in 3 phases: i) Survey the national scenario regarding the quality control of the molecular image in preclinical PET scanners. ii) Implement a Quality Control Program for LIM / CDTN. iii) Intercomparison between different laboratories. A questionnaire was sent to all services, tests to evaluate the image quality, spatial scattering, sensibility, and resolution using specific simulators as well as sealed radioactive sources. Operating procedures and specific forms were prepared for each test to guide the execution and record acquired data. In addition, the PET scanners from the Pontifical Catholic University of Rio Grande do Sul (PUC-RS) and the University of São Paulo (USP) were also evaluated. First phase revealed that service bosses know the NEMA publication 4-2008 and do not have yet but are interested in implementing the quality assurance program. Second phase demonstrated that LIM / CDTN detection systems have adequate reliability and reproducibility, and the acquired images are compatible with international quality standards for the molecular imaging research. Last phase of this work was the intercomparison between the different laboratories and confirmed that the proposal of national standardization it is important and viable to be presented for regulators bodies.
Downloads
References
AAPM. American Association of Physicists in Medicine. “The Selection, Use, Calibration, and Quality Assurance of Radionuclide calibrators used in Nuclear Medicine”, Report of AAPM Task Group 181. June, 2012.
ALESSIO, A. and KINAHAN, P., PET Image Reconstruction. Department of Radiology
University of Washington NE Pacific Street, Box 356004 Seattle, WA 98195-6004, USA. 1959.
ALESSIO, A. M. et al., Measured Spatially Variant System Response for PET Image Reconstruction. Nuclear Science Symposium Conference Record, 2005 IEEE, 4, 2005.
ANVISA - Agência Nacional de Vigilância Sanitária. RDC 64. Registro de Radiofármacos. ANVISA, 2009.
ANVISA - Agência Nacional de Vigilância Sanitária. RDC 63. Requisitos de Boas Práticas de Funcionamento para os Serviços de Saúde. ANVISA, 2011.
BAILEY, D. L., TOWNSEND, D. W., VALK, P. E. and MAISEY, M. N., Positron Emission Tomography: Basic Science and Clinical Practice. Springer-Verlag London Ltd,
BEGERON, M., CADORETTE, J., BUREAU-OXTON, C., BEAUDOIN, J. F., TÉTRAULT, M. A., LEROUX, J. D., LEPAGE, M. D., ROBERT, G., FONTAINE, R., LECOMTE, R., Performance Evaluation of the LabPET12, a Large Axial FOV APDbased Digital PET Scanner. IEEE Nuclear Science Symposium Conference Record. 2009.
BEGERON, M., CADORETTE, J., TÉTRAULT, M. A., BEAUDOIN, J. F., LEROUX, J. D., FONTAINE, R. and LECOMTE, R., Imaging performance of LabPET APD-based
digital PET Scanners for pre-clinical research. Physics in Medicine and Biology. v.59, pp.661-678, 2014.
CDTN – Centro de Desenvolvimento da Tecnologia Nuclear. Relatório Final de Análise de Segurança. Unidade de Radiobiologia. Serviço de Radiofarmácia. Rev. 02, 2016.
CIMBALA, J. M. Outliers. Penn State University. Latest Revision. 2011.
CNEN - Comissão Nacional de Energia Nuclear. Norma NN 3.05. Requisitos de segurança e proteção radiológica para serviços de medicina nuclear. (Resolução CNEN 159/13). 2013.
CNEN - Comissão Nacional de Energia Nuclear. Instalações autorizadas. 2017. Disponível em: <http://www.cnen.gov.br/instalacoes-autorizadas> Acessado em: 27 de Abril de 2019.
COSTA, F. M. Produção de 18F-Fluorcolina no Centro de Desenvolvimento da Tecnologia Nuclear: Síntese e Estudos de Citotoxicidade In Vitro. Dissertação. Ciência e Tecnologia das Radiações, Minerais e Materiais. CDTN/CNEN, 2015.
COX, B. L.; GRAVES, S. A.; FARHOUDS, M.; BARNHART, T.; JEFFERY, J. J.; ELICEIRI, K.; NICHKLES, R. J. Development of a novel linearity-filled Derenzo microPET
phantom. American Journal Nuclear Medicine Imaging, v.6(3), p.199-204, 2016.
DAHLE, T. J., Performance Evaluation of a Small-Animal PET/CT System. Master Thesis in Medical Physics. University of Bergen, 2014.
DANTAS, B. M., Bases para a Calibração de Contadores de Corpo Inteiro utilizando Simuladores Físicos Antropomórficos. Dissertação. Departamento de Biofísica e Biometria do Instituto de Biologia da Universidade do Estado do Rio de Janeiro, UERJ. 1998.
DECRISTOFORO, C.; DENNAN, S. The Radiopharmacy. European Association of Nuclear Medicine, p. 51, 2012.
DERENZO, S. E.; BUDINGER, T. F.; CAHOON, J. L.; HUESMAN, R. H.; JACKSON, H. G. high Resolution Computed tomography of Positron Emitters. IEEE transactions on Nuclear Science, v.NS-24(1), p.544-558, 1977.
DEVORE, J. L. Probabilidade e Estatística para Engenharia e Ciências. Ed. Cengale Learning. p.706. 2006.
DILWORTH, J. R. and PARROTT, S. J. The biomedical chemistry of technetium and rhenium. Chemical Society Reviews. v. 27, p. 43–55. 1998.
DISSELHORST, J. A., BROM, M., LAVERMAN. P., SLUMP, C. H., BOERMAN, O. C., OYEN, W. J. G., GOTHARDT, M., VISSER E. P., Image-Quality Assessment for Several Positron Emitters Using the NEMA NU 4-2008 Standards in the Siemens Inveon Small-Animal PET Scanner. The Journal of Nuclear Medicine. v.51(4), pp.610–617. 2010.
FAHEY, F. H., Data Acquisition in PET imaging. Journal of Nuclear Medicine Technology, v.30, n.2, pp. 239-249, 2002.
FAVERO, M. S., et al, Study of the acquisition and reconstruction parameters of myocardial perfusion images in the detection of lesions Revista Brasileira de Física
Médica. v.6(3), pp.163-166, 2012.
FERREIRA, F. G.; POLLI, M. C.; OSHIMA FRANCO, Y.; FRACETO, L. F. Fármacos: do desenvolvimento à retirada do mercado. Revista Eletrônica de Farmácia.
Goiás, v.6, n.1, p.14-24, 2009.
GAITANIS, A., KASTIS, G. A., VLASTOU. E., BOUZIOTIS, P., VERGINIS, P., ANAGNOSTOPOULOS, C. D., Investigation of Image Reconstruction Parameters of the
Mediso nanoScan PC Small-Animal PET/CT Scanner for Two Different Positron Emitters Under NEMA NU 4-2008 Standards. Molecular Imaging and Biology. v.19,
pp.550–559. 2016.
GAMBHIR SS. Molecular imaging of cancer with positron emission tomography. Nature Reviews Cancer. v.2, pp.683–693. 2002.
GE HealthCare. Triumph Pre-clinical tri-modality (PET/SPECT/CT) imaging system.
GOERTZEN A. L., NEMA NU 4-2008 Comparison of Preclinical PET Imaging Systems. The Journal of Nuclear Medicine. v.53(8), pp.1300–1309. 2012.
GONTIJO, R. M. G., FERREIRA, A. V., SILVA, J. B., MAMEDE, M. Image Quality Assessment using NEMA NU 4/2008 Standards in Small Animal PET Scanner. BJRS –
Brazilian Journal of Radiation Science. 07(2A). pp.1-13, 2019.
GONTIJO, R. M. G., FERREIRA, A. V., NASCIMENTO, L. T. C., COSTA, F. M., SILVA, J. B., MAMEDE, M. Constancy Tests and Quality Assurance of the Activimeters
used in a Radiopharmaceutical Production Unit. BJRS – Brazilian Journal of Radiation Science. 07(2A). pp.1-13, 2019.
GREEN, G. Wavelet-based denoising of cardiac PET data. Thesis in Electrical Engeneering. Canada University, 2005.
HUTCHINS, G. D., MILLER, M. A., SOON, V. C., RECEVEUR, T. Small Animal PET Imaging. ILAR Journal, Institute for Laboratory Animal Research. v.49(1), pp.54–65.
IAEA. International Atomic Energy Agency. “Quality Assurance for Radioactivity Measurements in Nuclear Medicine. Technical Report Series Nº 454”, Vienna, 2006.
IAEA. International Atomic Energy Agency. “Quality Control of Nuclear Medicine Instruments. IAEA-TEC-DOC-602”, Vienna, 2007.
IAEA. INTERNATIONAL ATOMIC ENERGY AGENCY. Cyclotron Produced Radionuclides: Principles and Practice. Series nº Ed. Vienna: [s.n.]. p. 230, 2008.
IAEA. International Atomic Energy Agency. Human Health Series N°1. Quality Assurance for PET and PET/CT Systems. Vienna, 2009.
IAEA. International Atomic Energy Agency (IAEA). Quality Control Guidance for Nuclear Medicine Equipment. Guidelines of Radiation and Nuclear Safety Authority – STUK, 2010.
KARP, J. S., WITHERSPOON, M. E. D., HOFFMAN, E. J., et al. Performance Standards in Positron Emission Tomography. Journal of Nuclear Medicine. v.32, pp.2342-
, 1991.
KUBO, T. T. A., BIANCARDI, R., ROCHA, A. M. G., FERREIRA, D. R., SILVA, F. A. A., ASSUNÇÃO, J. B. A., ALVES, E. H., ALMEIDA, A. F. B., ALVES, N. F., XAVIER,
F. H. Z., GONTIJO, R. M. G., and MAMEDE, M. Avaliação dos serviços de Medicina Nuclear do Estado de Minas Gerais: programa de controle de qualidade dos
equipamentos. ABFM. Revista Brasileira de Física Médica. 11(1), pp. 35-39, 2017.
LOMBARDINO, J. G.; LOWE, J. A. The role of the medicinal chemist in drug Discovery – then and now. Nature Reviews Drug Discovery. London, v.3, n.10, p.853-862,
NEMA. National Electrical Manufactures Association. NEMA Standards Publication NU 4-2008. Performance Measurements of Small Animal Positron Emission Tomographs. NEMA. 2008.
NEMA. National Electrical Manufactures Association. Disponível em: < http://www.nema.org> Acessado em: 10/10/2016.
OLIVEIRA, C. M., Propostas de implementações de aspectos metodológicos na utilização do 18F-FDG na tomografia por emissão de pósitron. Tese de Doutorado.
Programa de Ciências e Técnicas Nucleares da Engenharia Nuclear da UFMG, DEN/UFMG, 2013.
PAIVA, F. G. e GONTIJO, R. M. G., Levantamento dos Supervisores de Proteção Radiológica em Medicina Nuclear. Congresso Brasileiro de Radiologia - CBR, 2013.
POWSNER, R. A. & POWSNER E. R., Nuclear Medicine Physics. 2nd Ed. Blackwell Publishing, pp.206, 2006.
POZZO, L., Tomografia por Emissão de Pósitrons com Sistemas PET/SPECT: Um estudo da viabilidade de quantificação. Tese de Doutorado. Instituto de Física da
Universidade de São Paulo, IF/USP. 2005.
RATIB, O., PET/CT Image Navigation and Communication, Journal of Nuclear Medicine, v. 45, n. 1, pp. 46S-54S, 2004.
RATIB, O., ZAID, H., PRASAD, R. NEMA NU-04-based Performance Characteristics of the LabPET-8 TM Small Animal PET Scanner. IEEE Nuclear Science
Symposium Conference Record. pp.3654-3659, 2011.
ROBILOTTA CC. A tomografia por emissão de pósitrons: uma nova modalidade na medicina nuclear brasileira. Revista Panamericana de Salud Publica. V.20(2/3), pp.134-42, 2006.
SÁ, L. V., Controle de Qualidade da Imagem em Tomografia por Emissão de Pósitrons. Tese de Doutorado. Programa de Engenharia Nuclear, COPPE/UFRJ, 2010.
SAJI, H. Development of Radiopharmaceuticals for Molecular Imaging. Elsevier. International Congress Series. 1264 (2004) p.139 – 147. 2004.
SANTANA, M.G.C.; SOUZA, G.C.A.; GONTIJO, R.M.G.; FERREIRA, A.V. Efeito da Normalização dos Detectores na Qualidade da Imagem PET. IV SENCIR 2018 – IV
Semana de Engenharia Nuclear e Ciências das Radiações. Escola de Engenharia – UFMG. 2018.
SANTANA, M.G.C.; SOUZA, G.C.A.; GONTIJO, R.M.G.; MAMEDE, M.; MENDES, B. M.; FERREIRA, A.V. Influence of detector efficiency normalization on small animal
PET image quality. BJRS – Brazilian Journal of Radiation Science. Accept, 2019.
SCHNÖCKEL. U., HERMANN. S., STEGGER, L., et al. Small-animal PET: a promising, noninvasive tool in pre-clinical research. European Journal Pharmaceutics
Biopharmaceutics. v.74, pp: 50–54, 2010.
SHEPP, L. A. and VARDI, Y., Maximum likelihood reconstruction for emission tomography.; IEEE Trans. Med. Imag.; MI-1: 113 – 122. 1982.
SNMNI – Society of Nuclear Medicine & Molecular Imaging. 2018. Disponível em: <http://www.snmmi.org> Acessado em: 27 de Maio de 2018.
SORENSON, J. A. and PHELPS, M. E., Physics in Nuclear Medicine. 2nd Edição. WB Saunders, 1987.
STOUT, D. and KUNTNER, C., Quantitative preclinical PET imaging: opportunities and challenges. Frontiers in Physics. v.2, p.12, 2014.
SURESHBABU, W., MAWLAWI, O., PET/CT Imaging Artifacts, Journal of Nuclear Medicine, v.33, n. 3, pp. 156-161, 2005.
SZANDA, I., MACKEWN, J., et al. National Electrical Manufacturers Association NU-04 Performance Evaluation of the PET Component of the NanoPET/CT Preclinical
PET Scanner. Journal Nuclear Medicine. v.52, pp.1741-1747, 2011.
WOODS, M. J. Chapter 10 “Quality Control of Radionuclide Calibrators” in Quality Control of Nuclear Medicine Instrumentation. R.F. Mould. York, UK: Institute of Physics and Engineering in Medicine (IPEM), 1983.
YAO, R., LECOMTE, R., CRAWFORD, E. S., Small-Animal PET: What is it, and Why do we need it, Journal Nuclear Medicine Technology, Vol. 40, pp.157-165, 2012.
ZANZONICO, P., Positron Emission Tomography: A Review of Basic Principles, Scanner Design and Performance, and Current Systems. Seminars in Nuclear Medicine, Vol. XXXIV, n.2, pp.87-111, 2004.
ZANZONICO, P., Routine Quality Control of Clinical Nuclear Medicine Instrumentation: A Brief Review*. Journal Nuclear Medicine, v.49, pp.1114-1131, 2008.
ZIMMERMAN, B. E., and CESSNA, J. T. Experimental determinations of commercial ‘dose calibrator’ settings for nuclides used in nuclear medicine. Applied
Radiation Isotope 52, pp.615–619, 2000.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2022 Rodrigo Modesto Gadelha Gontijo
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
The submission of original articles to the Brazilian Journal of Medical Physics implies the transfer, by the authors, of the rights of print and digital publication. Copyright for published articles remains with the author, with journal rights on first publication. Authors may only use the same results in other publications by clearly indicating this journal as the original publisher. As we are an open access journal, free use of articles in educational, scientific, non-commercial applications is allowed, as long as the source is cited.
The Brazilian Journal of Medical Physics is under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND 4.0).
