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 may 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.
KeywordsFlurpiridaz dosimetry and biodistribution myocardial perfusion PET imaging exercise cardiac PET imaging safety
F-18-labeled flurpiridaz (flurpiridaz F 18)
Positron emission tomography
Roentgen equivalent man
Myocardial perfusion imaging
Body mass index
Percent injected dose
Region of interest
The authors wish to acknowledge the assistances of Jean-Richard Eugene, CNMT in PET image acquisition and processing, Deborah Dorsey, RN, and Parham Naghdechi, MD in the recruitment and monitoring of the research subjects. The authors are grateful to Susan Ramsey for analyzing the data and for helpful comments on drafts of the manuscript. Financial support for this study was provided by Lantheus Medical Imaging, Billerica, MA.
Jamshid Maddahi is the Chair of the Steering Committee, Member of the Scientific Advisory Board and received grant funding from Lantheus Medical Imaging (LMI) for this study. Frank Bengel and Richard Sparks received grant funding from LMI. Paul Crane and Joel Lazewatsky are employees of LMI. Johannes Czernin, Magnus Dahlbom, Heinrich Schelbert, and Michael Phelps declare that they have no conflict of interest related to this study.
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