dosimetry, biodistribution, and safety of flurpiridaz f 18 in healthy subjects undergoing rest and exercise or pharmacological stress pet myocardial perfusion imaging

The objectives of this study were to evaluate radiation dosimetry, biodistribution, human safety, and tolerability of 18f-labeled flurpiridaz (flurpiridaz) in normal subjects undergoing rest and separate-day exercise or adenosine pharmacological stress pet imaging. 12 normal subjects were injected with 58.5 to 121 mbq (1.58 to 3.27 mci) of flurpiridaz intravenously at rest on day 1 and 57 to 171 mbq (1.54 to 4.61 mci) during stress on day 2. sequential whole-body imaging was performed for 5 hours. blood samples were collected for up to 8 hours. the heart wall received the largest mean absorbed dose with both exercise and adenosine stresses. the mean effective dose was 0.054 rem/mci (0.015 msv/mbq) with exercise and 0.069 rem/mci (0.019 msv/mbq) with adenosine pharmacological stress. the maximum dose that be administered without exceeding 1 rem (10 msv) effective dose was 19 mci (685 mbq) for exercise and 15 mci (539 mbq) for adenosine pharmacological stress. there were no drug-related adverse events, and the tracer was well tolerated in all subjects. based on radiation dosimetry, biodistribution, and safety observations, 18f-labeled flurpiridaz is found suitable for clinical pet myocardial perfusion imaging in conjunction with either exercise or pharmacological stress testing.