Jamshid Maddahi1,2, Frank Bengel3,4, Johannes Czernin5, Paul Crane6, Magnus Dahlbom5, Heinrich Schelbert5, Richard Sparks7, Michael Phelps5, Joel Lazewatsky6. 1. Department of Molecular and Medical Pharmacology (Nuclear Medicine), David Geffen School of Medicine at University of California, Los Angeles (UCLA), 100 UCLA Medical Plaza Suite 410, Los Angeles, CA, 90095-7064, USA. jmaddahi@gmail.com. 2. Department of Medicine (Cardiology), David Geffen School of Medicine at University of California, Los Angeles (UCLA), Los Angeles, CA, USA. jmaddahi@gmail.com. 3. The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA. 4. Medizinische Hochschule Hannover, Hannover, Germany. 5. Department of Molecular and Medical Pharmacology (Nuclear Medicine), David Geffen School of Medicine at University of California, Los Angeles (UCLA), 100 UCLA Medical Plaza Suite 410, Los Angeles, CA, 90095-7064, USA. 6. Lantheus Medical Imaging, Billerica, MA, USA. 7. CDE Dosimetry Services, Knoxville, TN, USA.
Abstract
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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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. METHODS: 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. RESULTS: The heart wall received the largest mean absorbed dose with both exercise and adenosinestresses. 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. CONCLUSION: 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.
Entities:
Keywords:
Flurpiridaz; dosimetry and biodistribution; exercise cardiac PET imaging; myocardial perfusion PET imaging; safety
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