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

NCT02411201 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-03-09

Study results available
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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

DRUG

DOTAREM

Single intravenous injection of 0.1 mmol/kg body weight

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Project Manager · Guerbet

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Austria
  • France
  • Hungary
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02411201 on ClinicalTrials.gov