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Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions

NCT01211873 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2019-04-18

Study results available
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Summary

The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

Conditions

Interventions

DRUG

Dotarem (gadoterate meglumine)

0.1 mmol/kg by body weight, single IV injection

DRUG

Magnevist (gadopentetate dimeglumine)

0.1 mmol/kg by body weight, single IV injection

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Ken Maravilla, MD · University of Wasington School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Chile
  • France
  • Germany
  • Italy
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT01211873 on ClinicalTrials.gov