Format

Send to

Choose Destination
J Nucl Cardiol. 2018 Nov 28. doi: 10.1007/s12350-018-01484-z. [Epub ahead of print]

Dosimetry, biodistribution, and safety of flurpiridaz F 18 in healthy subjects undergoing rest and exercise or pharmacological stress PET myocardial perfusion imaging.

Author information

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.

KEYWORDS:

Flurpiridaz; dosimetry and biodistribution; exercise cardiac PET imaging; myocardial perfusion PET imaging; safety

PMID:
30488323
DOI:
10.1007/s12350-018-01484-z

Supplemental Content

Full text links

Icon for Springer
Loading ...
Support Center