[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. 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. [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. 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. EudraCT number: 2016-001190-32. Registered 16 March 2016, no URL available for phase 1 trials.

中文翻译：

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[ ¹¹ C] -UCB-J的人体生物分布和剂量测定，一种用于显像突触密度的PET示踪剂

[11C] -UCB-J是一种新兴的工具，用于在体内无创测量突触小泡密度。在这里，我们报告使用两个版本的OLINDA剂量测定程序从顺序的全身PET得出的人体生物分布和剂量测定估计值。注射254±77 MBq [11C] -UCB-J后，对3名健康受试者进行了2个小时的全身PET扫描。在相关的源器官上绘制感兴趣的体积，以生成时间-活动曲线并计算时间积分的活动系数，并使用OLINDA 2.1计算有效剂量系数，并将其与从OLINDA 1.1和文献中最近报道的值进行比较。[11C] -UCB-J给药安全，显示肾脏和肝胆混合清除率，膀胱壁和小肠的器官吸收剂量系数最大（分别为21.7和23.5μGy/ MBq）。OLINDA 1.1版和2.1版的平均有效剂量系数分别为5.4±0.7和5.1±0.8μSv/ MBq。使用这两种软件版本的剂量均低于文献中先前报告的剂量。370 MBq [11C] -UCB-J的单次IV给药对应的有效剂量小于2.0 mSv，从而可以在同一受试者中进行多次PET检查。EudraCT号：2016-001190-32。注册于2016年3月16日，没有可用于第一阶段试验的URL。使用这两种软件版本的剂量均低于文献中先前报告的剂量。370 MBq [11C] -UCB-J的单次IV给药对应的有效剂量小于2.0 mSv，从而可以在同一受试者中进行多次PET检查。EudraCT号：2016-001190-32。注册于2016年3月16日，没有可用于第一阶段试验的URL。使用这两种软件版本的剂量均低于先前文献中报道的剂量。370 MBq [11C] -UCB-J的单次IV给药对应的有效剂量小于2.0 mSv，从而可以在同一受试者中进行多次PET检查。EudraCT号：2016-001190-32。注册于2016年3月16日，没有可用于第一阶段试验的URL。