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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.
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Details

1 KU Leuven, Nuclear Medicine and Molecular Imaging, Department of Imaging and Pathology, Leuven, Belgium (GRID:grid.5596.f) (ISNI:0000 0001 0668 7884)
2 UCB Pharma, Braine l’Alleud, Belgium (GRID:grid.421932.f) (ISNI:0000 0004 0605 7243)
3 University Hospitals Leuven, Division of Nuclear Medicine, Leuven, Belgium (GRID:grid.410569.f) (ISNI:0000 0004 0626 3338)
4 KU Leuven, Laboratory for Radiopharmaceutical Research, Leuven, Belgium (GRID:grid.5596.f) (ISNI:0000 0001 0668 7884)
5 University Hospitals Leuven, Center for Clinical Pharmacology, Leuven, Belgium (GRID:grid.410569.f) (ISNI:0000 0004 0626 3338)
6 KU Leuven, Nuclear Medicine and Molecular Imaging, Department of Imaging and Pathology, Leuven, Belgium (GRID:grid.5596.f) (ISNI:0000 0001 0668 7884); University Hospitals Leuven, Division of Nuclear Medicine, Leuven, Belgium (GRID:grid.410569.f) (ISNI:0000 0004 0626 3338)