Abstract:
PURPOSE:4-[(18)F]-ADAM is a potent serotonin transport imaging agent. We studied its toxicity in rats and radiation dosimetry in monkeys before human studies are undertaken. METHODS:Single and multiple-dosage toxicity studies were conducted in Sprague-Dawley rats. Male and female rats were injected intravenously with 4-F-ADAM as a single dose of 1,023.7 microg/kg (1,000 times the human dose) or as five consecutive daily doses of 102.37 microg/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 4-[(18)F]-ADAM (182+/-8 MBq), a low dose CT scan and a series of eight whole-body PET scans were performed. Whole-body images were acquired in 3-D mode. Time-activity data of source organs were used to calculate the residence times and estimate the absorbed radiation dose using OLINDA/EXM software. RESULTS:In the rats neither the single dose nor the five daily doses of 4-F-ADAM produced overt adverse effects clinically. In the monkeys the radiation doses received by most organs ranged between 7.1 and 35.7 microGy/MBq, and the urinary bladder was considered to be the critical organ. The effective doses extrapolated to male and female adult humans were 17.4 and 21.8 microSv/MBq, respectively. CONCLUSION:Toxicity studies in Sprague-Dawley rats and radiation dosimetry studies in Formosa Rock monkeys suggested that 4-[(18)F]-ADAM is safe for use in human PET imaging studies.
journal_name
Eur J Nucl Med Mol Imagingauthors
Huang YY,Ma KH,Tseng TW,Chou TK,Ng H,Mirsalis JC,Fu YK,Chu TC,Huang WS,Shiue CYdoi
10.1007/s00259-009-1281-zsubject
Has Abstractpub_date
2010-03-01 00:00:00pages
545-55issue
3eissn
1619-7070issn
1619-7089journal_volume
37pub_type
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journal_title:European journal of nuclear medicine and molecular imaging
pub_type: 杂志文章
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journal_title:European journal of nuclear medicine and molecular imaging
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pub_type: 杂志文章
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更新日期:2004-06-01 00:00:00
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journal_title:European journal of nuclear medicine and molecular imaging
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pub_type: 临床试验,杂志文章
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pub_type: 临床试验,杂志文章
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pub_type: 杂志文章
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更新日期:2018-07-01 00:00:00
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pub_type: 杂志文章,评审
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