title: The [14C-N-methyl]-erythromycin breath test dosimetry complies with the French regulations for radiation safety.
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.
authors.affiliation: Department of Nuclear Medicine, Lariboisière Hospital, Paris, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Salvat
authors.forename: Stéphane
authors.initials: S
authors.lastname: Mouly
authors.forename: Nathalie
authors.initials: N
authors.lastname: Rizzo-Padoin
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Knellwolf
authors.forename: Guy
authors.initials: G
authors.lastname: Simoneau
authors.forename: Michèle
authors.initials: M
authors.lastname: Duet
authors.forename: Valérie
authors.initials: V
authors.lastname: Nataf
authors.forename: Olivier
authors.initials: O
authors.lastname: Bailliart
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Bergmann
mesh_terms: D000818:Animals; D001944:Breath Tests / Q000379:methods*; D002250:Carbon Radioisotopes / Q000009:adverse effects*; D004917:Erythromycin / Q000009:adverse effects* / Q000493:pharmacokinetics; D005602:France; D006801:Humans; D017056:Medical Laboratory Personnel; D016273:Occupational Exposure / Q000009:adverse effects; D011871:Radiology / Q000331:legislation & jurisprudence; D011874:Radiometry / Q000379:methods / Q000592:standards*; D012449:Safety / Q000331:legislation & jurisprudence
chemical_list: D002250:Carbon Radioisotopes; D004917:Erythromycin