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Quantification and monitoring of PET/CT data in multicentre trials: The Swiss SAKK 56/07 trial experience
Institution:1. Institute of radiation physics, Lausanne university hospital, Lausanne, Switzerland;2. Nuclear medicine department, Lausanne university hospital, Lausanne, Switzerland;2. John Paul II, Krakow, Poland;3. Texas Heart Institute, St. Lukes Hospital, Houston, Texas;4. University of Utah, Salt Lake City, Utah;5. University of San Francisco, San Francisco, California;11. Vanderbilt University Medical Center, Nashville, Tennessee;1. Department of Transplantation Medicine and Nephrology, Medical University of Warsaw, Warsaw, Poland;2. Department of Internal Medicine and Cardiology, Medical University of Warsaw, Warsaw, Poland;3. Department of General and Transplantation Surgery, Medical University of Warsaw, Warsaw, Poland;4. Department of General, Vascular and Transplantation Surgery, Medical University of Warsaw, Warsaw, Poland;5. Department of Nephrology, Kidney Transplantation and Hypertension Children''s Memorial Health Institute, Warsaw, Poland;1. GROW School for Oncology and Developmental Biology, Maastricht University, P.O. Box 616, 6200 MD, The Netherlands;2. Department of Radiology, The Netherlands Cancer Institute, P.O. Box 90203, 1006 BE Amsterdam, The Netherlands;3. Department of Radiology, Maastricht University Medical Center, P.O. Box 6200, 6202 AZ Maastricht, The Netherlands;4. Department of Surgery, Maastricht University Medical Center, P.O. Box 6200, 6202 AZ Maastricht, The Netherlands;5. Department of Radiology, Zhongshan Hospital, Fudan University,180 Fenglin Road Shangai 200032, China;6. Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University, P.O. Box 6200, 6202 AZ Maastricht, , The Netherlands;7. Department of Surgery, The Netherlands Cancer Institute, P.O. Box 90203, 1006 BE Amsterdam, The Netherlands;8. NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, P.O. Box 616, 6200 MD, The Netherlands;9. Department of Surgery, RWTH Universitätsklinikum Aachen, Pauwelsstraße 30, 52074 Aachen, Germany;10. Department of Surgical Oncology, Erasmus MC Cancer Institute, Groene Hilledijk 301, 3075 EA, Rotterdam, The Netherlands;1. Department of Orthopaedics & Traumatology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong;2. Department of Biomedical Engineering, Faculty of Engineering, The Hong Kong Polytechnic University, Hung Hom, Hong Kong;1. Department of Radiation Oncology, Winship Cancer Institute of Emory University, Emory University School of Medicine, Atlanta, GA;2. Department of Biostatistics and Bioinformatics, Winship Cancer Institute of Emory University, Emory University School of Medicine, Atlanta, GA;3. Department of Medical Oncology, Winship Cancer Institute of Emory University, Emory University School of Medicine, Atlanta, GA;4. Department of Thoracic Surgery, Winship Cancer Institute of Emory University, Emory University School of Medicine, Atlanta, GA
Abstract:AimTo outline the importance of continuous monitoring of quantitative positron emission tomography (PET) data in multicentre trials to minimize quantitative bias in longitudinal intra-patient PET studies in light of the multicentre SAKK 56/07 experience in quantification and monitoring 18F-FDG PET/CT data.Patients and methodsWe collected 64 uniform phantom 18F-FDG PET acquisitions periodically at the enrolling centres (12 European institutions). A core-laboratory analysed them for standard uptake value (SUV) accuracy (desired 1.00 ± 10%) and acceptable image noise was defined by a coefficient of variation (COV) less than 15%. In total, 151 patients 18F-FDG PET acquisitions (baseline and follow-up) were also collected and analysed to verify longitudinal coherence of main acquisition/reconstruction parameters (DICOM tags verification) and patient preparation, in particular the uptake time (desired uptake time UT] = 60 ± 10 min).ResultsUniform phantom PET acquisition satisfied the inclusion criteria in 58/64 (89%) examinations. All PET scanner exhibited comparable SUV quantification, but we found large dispersion in terms of noise, with COV ranging 3–15%. Only 1 phantom PET acquisition was out of range with COV = 21.5%. Patient data exhibited important variation in uptake time with UT = 65 ± 10 min (mean ± SD), with only 111/151 (74%) patients’ examinations satisfying inclusion criteria while 26% were out of range.ConclusionsRegular monitoring of PET data in multicentre trials is capital to ensure longitudinal intra-patient PET data consistence and minimize quantitative bias while it helps to spread the culture of quality in participating centre. Recent EARL (EANM Research Ltd) standardization and unification of procedures is a welcome step in this direction.
Keywords:Positron emission tomography  PET quantification  Standardized uptake value  Multicentre trials  Standardization  Tomographie par émission de positron  Quantification TEP  Essais cliniques multicentriques  Standardisation
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