NCT02411201

DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years

DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Magnetic Resonance Imaging

Interventions

Type	Name	Description
DRUG	DOTAREM	Single intravenous injection of 0.1 mmol/kg body weight

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-04-08
• Last updated: 2017-03-09
• Results posted: 2017-03-09

Locations

9 sites across 4 countries: Austria, France, Hungary, Poland