Dosimetry, biodistribution, and safety of flurpiridaz F 18 in healthy subjects undergoing rest and exercise or pharmacological stress PET myocardial perfusion imaging.
Flurpiridaz
dosimetry and biodistribution
exercise cardiac PET imaging
myocardial perfusion PET imaging
safety
Journal
Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology
ISSN: 1532-6551
Titre abrégé: J Nucl Cardiol
Pays: United States
ID NLM: 9423534
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
30
12
2016
accepted:
21
09
2018
pubmed:
30
11
2018
medline:
11
11
2020
entrez:
30
11
2018
Statut:
ppublish
Résumé
The objectives of this study were to evaluate radiation dosimetry, biodistribution, human safety, and tolerability of 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,
Identifiants
pubmed: 30488323
doi: 10.1007/s12350-018-01484-z
pii: 10.1007/s12350-018-01484-z
doi:
Substances chimiques
BMS 747158-02
0
Pyridazines
0
Radiopharmaceuticals
0
Adenosine
K72T3FS567
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2018-2030Commentaires et corrections
Type : CommentIn
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