CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 51 enrolled
Drug / intervention
DOTAREMdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02411201
NCT02411201Phase 4Completed
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DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

Guerbet·interventional·Posted Apr 8, 2015·Updated Mar 9, 2017

In Brief

A Phase 4 clinical trial evaluating DOTAREM for Magnetic Resonance Imaging. Completed, enrolled 51 participants across 9 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMagnetic Resonance Imaging
CountriesAustria, France, Hungary, Poland
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 8, 2015
Enrollment StartMar 1, 2015
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.2 years ago

Interventions

DOTAREMdrug

Single intravenous injection of 0.1 mmol/kg body weight