Post-marketing Surveillance Study for Evaluation of Dotarem Safety

NCT ID: NCT03048006

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44456 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-12-31

Brief 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.

Detailed Description

Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.

Conditions

Contrast-enhanced MRI With Dotarem

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All included patients

All included patients underwent MRI with Dotarem

MRI with Dotarem

Intervention Type: PROCEDURE

Interventions

MRI with Dotarem

Intervention Type: PROCEDURE

Other Intervention Names

MRI with gadoteric acid/gadoterate meglumine

Eligibility Criteria

Inclusion Criteria

• Patients undergoing routine MRI using the MRI contrast medium Dotarem

Exclusion Criteria

-

• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guerbet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DGD-55-005

Identifier Type: -

Identifier Source: org_study_id