DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of
children aged less than 2 years thanks to several blood samples (3 ml in total) taken
following the administration of DOTAREM®.
DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging
(MRI) to potentially improve the quality of the images and help the diagnosis. Children aged
less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may
take part in the study. In this case they will receive DOTAREM®, a solution injected at the
standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.