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Post-marketing Surveillance Study for Evaluation of Dotarem Safety

NCT03048006 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44456

Last updated 2017-05-02

Study results available
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Summary

Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.

Conditions

  • Contrast-enhanced MRI With Dotarem

Interventions

PROCEDURE

MRI with Dotarem

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Eligibility

Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

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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 NCT03048006 on ClinicalTrials.gov