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Post-marketing Surveillance Study for Evaluation of Dotarem Safety

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ClinicalTrials.gov Identifier: NCT03048006
Recruitment Status : Completed
First Posted : February 9, 2017
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Guerbet

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.

Condition or disease Intervention/treatment
Contrast-enhanced MRI With Dotarem Procedure: MRI with Dotarem

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.

Study Type : Observational
Actual Enrollment : 44456 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Dotarem Safety
Study Start Date : January 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
All included patients
All included patients underwent MRI with Dotarem
Procedure: MRI with Dotarem
Other Name: MRI with gadoteric acid/gadoterate meglumine



Primary Outcome Measures :
  1. Frequency of Adverse Events [ Time Frame: From the beginning of the MRI procedure to 30-60 min after ]
    The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.


Secondary Outcome Measures :
  1. Diagnostic Value [ Time Frame: During MRI procedure ]
    Diagnostic value was evaluated by answering "yes" or "no" to the following question "Were you able to make a diagnosis based on the test results ?"

  2. Image Quality [ Time Frame: During MRI procedure ]
    Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "moderate"; "poor" and "very poor")



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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult and pediatric patients undergoing routine MRI using the MRI contrast medium Dotarem
Criteria

Inclusion Criteria:

  • Patients undergoing routine MRI using the MRI contrast medium Dotarem

Exclusion Criteria:


Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT03048006     History of Changes
Other Study ID Numbers: DGD-55-005
First Posted: February 9, 2017    Key Record Dates
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017
Last Verified: March 2017