Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2003 Jun;17(3):349-53.
doi: 10.1046/j.1472-8206.2003.00139.x.

The [14C-N-methyl]-erythromycin breath test dosimetry complies with the French regulations for radiation safety

Cécile Salvat  1 , Stéphane Mouly, Nathalie Rizzo-Padoin, Anne-Laure Knellwolf, Guy Simoneau, Michèle Duet, Valérie Nataf, Olivier Bailliart, Jean-François Bergmann
Affiliations

The [14C-N-methyl]-erythromycin breath test dosimetry complies with the French regulations for radiation safety

Cécile Salvat et al. Fundam Clin Pharmacol. 2003 Jun.

Abstract

The [14C-N-methyl]-erythromycin breath test (14C-ERMBT) is one of the most valuable probes for liver cytochrome P450-3A4 activity in humans. In order to extend the use of this test in France, we herein provide safety data regarding either patient dosimetry or worker exposure to [14C-N-methyl]-erythromycin. In order to determine the maximum radiation exposure for patient and nuclear medicine technician following one intravenous 14C-ERMBT [111 kiloBequerel (kBq)], we have used the dosimetric data gathered in animal studies and extrapolated to humans using a weight-based method, approximate data provided by the French Society of Radioprotection and erythromycin pharmacokinetics in humans, considering always the worst conditions for the patient and worker exposure determination. The radioactivity administered to a patient after one 14C-ERMBT was equal to 108.8 kBq (i.e. 98% of the total radioactivity in the 14C-erythromycin vial) leading to a patient effective dose of 20 microsievert (microSv) and a maximum effective dose after 14CO2 inhalation by the exposed worker of 16 microSv compared with a mean individual annual effective dose from natural and artificial radioactivity exposure of 3500 microSv in France. The 14C-ERMBT is safe and complies with the European regulations regarding the administration of 14C-labelled compounds in humans. It can therefore be used in clinical research in France without any particular safety requirement.

PubMed Disclaimer

LinkOut - more resources