Abstract
Purpose
[18F]fluorodeoxysorbitol ([18F]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 [18F]FDS in healthy human bodies.
Procedures
Six healthy subjects were intravenously injected with 320–520 MBq [18F]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 [18F]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
[18F]FDS is safe and well tolerated. The effective dose was comparable to that of other F-18 labeled radiotracers. [18F]FDS is suitable for human use from a radiation dosimetry perspective.
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Acknowledgments
This work was supported in part by the National Natural Science Foundation of China (Grant No. 81071188 and 81571713). We would like to extend our heartiest gratitude to Prof. Yun Zhou for the support of data management and study preparation.
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All procedures of the study were approved by the Institutional Review Board of Peking Union Medical College Hospital.
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Zhu, W., Yao, S., Xing, H. et al. Biodistribution and Radiation Dosimetry of the Enterobacteriaceae-Specific Imaging Probe [18F]Fluorodeoxysorbitol Determined by PET/CT in Healthy Human Volunteers. Mol Imaging Biol 18, 782–787 (2016). https://doi.org/10.1007/s11307-016-0946-9
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DOI: https://doi.org/10.1007/s11307-016-0946-9