Authors: YaYao Huang KuoHsing Ma TaWei Tseng TaKai Chou Hanna Ng Jon C Mirsalis YingKai Fu TiehChi Chu WenSheng Huang ChyngYann Shiue
Publish Date: 2009/10/10
Volume: 37, Issue: 3, Pages: 545-555
Abstract
Single and multipledosage toxicity studies were conducted in SpragueDawley rats Male and female rats were injected intravenously with 4FADAM as a single dose of 10237 μg/kg 1000 times the human dose or as five consecutive daily doses of 10237 μg/kg 100 times the human dose PET/CT scans were performed in seven Formosa Rock monkeys four males and three females using a Siemens Biograph scanner After injection of 418FADAM 182±8 MBq a low dose CT scan and a series of eight wholebody PET scans were performed Wholebody images were acquired in 3D mode Time–activity data of source organs were used to calculate the residence times and estimate the absorbed radiation dose using OLINDA/EXM softwareIn the rats neither the single dose nor the five daily doses of 4FADAM produced overt adverse effects clinically In the monkeys the radiation doses received by most organs ranged between 71 and 357 μGy/MBq and the urinary bladder was considered to be the critical organ The effective doses extrapolated to male and female adult humans were 174 and 218 μSv/MBq respectivelyWe thank the Institute of Nuclear Energy Research of Taiwan for providing the OLINDA 10/EXM computer program The synthesis of 4FADAM was funded by the National Institute of Mental Health NIMH under contract no NO1MH32005 Toxicology studies were also funded by NIMH under contract no M42205 This work was supported by the National Science Council of Taiwan grants NSC 952811B016002 952321B016001MY2 and 962811B016004
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