Koen Van Laere1,2, Michel Koole3, Christopher Cawthorne1, Paul Maguire4, Joel Mercier4, David Sciberras4, Kim Serdons2, Guy Bormans5, Jan de Hoon6. 1. Nuclear Medicine and Molecular Imaging, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium. 2. Division of Nuclear Medicine, University Hospitals Leuven, Leuven, Belgium. 3. Nuclear Medicine and Molecular Imaging, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium. michel.koole@uzleuven.be. 4. UCB Pharma, Braine l'Alleud, Belgium. 5. Laboratory for Radiopharmaceutical Research, KU Leuven, Leuven, Belgium. 6. Center for Clinical Pharmacology, University Hospitals Leuven, Leuven, Belgium.
Abstract
RATIONALE: [11C]-UCB-J is an emerging tool for the noninvasive measurement of synaptic vesicle density in vivo. Here, we report human biodistribution and dosimetry estimates derived from sequential whole-body PET using two versions of the OLINDA dosimetry program. METHODS: Sequential whole-body PET scans were performed in 3 healthy subjects for 2 h after injection of 254 ± 77 MBq [11C]-UCB-J. Volumes of interest were drawn over relevant source organs to generate time-activity curves and calculate time-integrated activity coefficients, with effective dose coefficients calculated using OLINDA 2.1 and compared to values derived from OLINDA 1.1 and those recently reported in the literature. RESULTS: [11C]-UCB-J administration was safe and showed mixed renal and hepatobiliary clearance, with largest organ absorbed dose coefficients for the urinary bladder wall and small intestine (21.7 and 23.5 μGy/MBq, respectively). The average (±SD) effective dose coefficient was 5.4 ± 0.7 and 5.1 ± 0.8 μSv/MBq for OLINDA versions 1.1 and 2.1 respectively. Doses were lower than previously reported in the literature using either software version. CONCLUSIONS: A single IV administration of 370 MBq [11C]-UCB-J corresponds to an effective dose of less than 2.0 mSv, enabling multiple PET examinations to be carried out in the same subject. TRIAL REGISTRATION: EudraCT number: 2016-001190-32. Registered 16 March 2016, no URL available for phase 1 trials.
RATIONALE: [11C]-UCB-J is an emerging tool for the noninvasive measurement of synaptic vesicle density in vivo. Here, we report human biodistribution and dosimetry estimates derived from sequential whole-body PET using two versions of the OLINDA dosimetry program. METHODS: Sequential whole-body PET scans were performed in 3 healthy subjects for 2 h after injection of 254 ± 77 MBq [11C]-UCB-J. Volumes of interest were drawn over relevant source organs to generate time-activity curves and calculate time-integrated activity coefficients, with effective dose coefficients calculated using OLINDA 2.1 and compared to values derived from OLINDA 1.1 and those recently reported in the literature. RESULTS: [11C]-UCB-J administration was safe and showed mixed renal and hepatobiliary clearance, with largest organ absorbed dose coefficients for the urinary bladder wall and small intestine (21.7 and 23.5 μGy/MBq, respectively). The average (±SD) effective dose coefficient was 5.4 ± 0.7 and 5.1 ± 0.8 μSv/MBq for OLINDA versions 1.1 and 2.1 respectively. Doses were lower than previously reported in the literature using either software version. CONCLUSIONS: A single IV administration of 370 MBq [11C]-UCB-J corresponds to an effective dose of less than 2.0 mSv, enabling multiple PET examinations to be carried out in the same subject. TRIAL REGISTRATION: EudraCT number: 2016-001190-32. Registered 16 March 2016, no URL available for phase 1 trials.
Entities:
Keywords:
Human biodistribution; OLINDA; Radiation dosimetry; Synaptic density; [11C]-UCB-J
Authors: Michel Koole; June van Aalst; Martijn Devrome; Nathalie Mertens; Kim Serdons; Brigitte Lacroix; Joel Mercier; David Sciberras; Paul Maguire; Koen Van Laere Journal: Eur J Nucl Med Mol Imaging Date: 2018-08-18 Impact factor: 9.236
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