Wenjia Zhu1, Shaobo Yao1, Haiqun Xing1, Hui Zhang2, Yuan-Chuan Tai3, Yingqiang Zhang1, Yimin Liu1, Yanru Ma1, Chenxi Wu1, Hongkai Wang4, Zibo Li5, Zhanhong Wu5, Zhaohui Zhu1, Fang Li1, Li Huo6. 1. Department of Nuclear Medicine, Peking Union Medical College Hospital, 1# Shuaifuyuan, Dongcheng District, Beijing, China. 2. Department of Biomedical Engineering, Tsinghua University, Beijing, China. 3. Department of Radiology, Washington University in St Louis, St Louis, MI, USA. 4. Department of Biomedical Engineering, Dalian University of technology, Dalian, China. 5. Department of Radiology and Biomedical Research Imaging Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA. 6. Department of Nuclear Medicine, Peking Union Medical College Hospital, 1# Shuaifuyuan, Dongcheng District, Beijing, China. Huoli@pumch.cn.
Abstract
PURPOSE: [(18)F]fluorodeoxysorbitol ([(18)F]FDS) is the first radiopharmaceutical specific for a category of bacteria and has the potential to specifically detect Enterobacteriaceae infections. The purpose of this study was to testify the safety and investigate the biodistribution and radiation dosimetry of [(18)F]FDS in healthy human bodies. PROCEDURES: Six healthy subjects were intravenously injected with 320-520 MBq [(18)F]FDS. On each subject, 21 whole-body emission scans and a brain scan were conducted at settled time points within the next 4 h. Residence time for each source organ was determined by multi-exponential regression. Absorbed doses for target organs and effective dose were calculated via OLINDA/EXM. RESULTS: No adverse events due to [(18)F]FDS injection were observed in the study. The tracer was cleared rapidly from the blood pool through the urinary system. A small portion was cleared into the gut through the hepatobiliary system. The effective dose (ED) was estimated to be 0.021 ± 0.001 mSv/MBq. The organ receiving the highest absorbed dose was the urinary bladder wall (0.25 ± 0.03 mSv/MBq). CONCLUSIONS: [(18)F]FDS is safe and well tolerated. The effective dose was comparable to that of other F-18 labeled radiotracers. [(18)F]FDS is suitable for human use from a radiation dosimetry perspective.
PURPOSE: [(18)F]fluorodeoxysorbitol ([(18)F]FDS) is the first radiopharmaceutical specific for a category of bacteria and has the potential to specifically detect Enterobacteriaceae infections. The purpose of this study was to testify the safety and investigate the biodistribution and radiation dosimetry of [(18)F]FDS in healthy human bodies. PROCEDURES: Six healthy subjects were intravenously injected with 320-520 MBq [(18)F]FDS. On each subject, 21 whole-body emission scans and a brain scan were conducted at settled time points within the next 4 h. Residence time for each source organ was determined by multi-exponential regression. Absorbed doses for target organs and effective dose were calculated via OLINDA/EXM. RESULTS: No adverse events due to [(18)F]FDS injection were observed in the study. The tracer was cleared rapidly from the blood pool through the urinary system. A small portion was cleared into the gut through the hepatobiliary system. The effective dose (ED) was estimated to be 0.021 ± 0.001 mSv/MBq. The organ receiving the highest absorbed dose was the urinary bladder wall (0.25 ± 0.03 mSv/MBq). CONCLUSIONS: [(18)F]FDS is safe and well tolerated. The effective dose was comparable to that of other F-18 labeled radiotracers. [(18)F]FDS is suitable for human use from a radiation dosimetry perspective.
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