Post-marketing Surveillance Study for Evaluation of Dotarem Safety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03048006
Recruitment Status : Completed
First Posted : February 9, 2017
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):

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

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")

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
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

Inclusion Criteria:

  • Patients undergoing routine MRI using the MRI contrast medium Dotarem

Exclusion Criteria:

Responsible Party: Guerbet 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