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Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography

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ClinicalTrials.gov Identifier: NCT03041298
Recruitment Status : Completed
First Posted : February 2, 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) from September 2011 to December 2013. The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in Magnetic Resonance (MR) mammography.

Condition or disease Intervention/treatment
MR Mammography With Dotarem Procedure: MR mammography with Dotarem

Detailed Description:
Diagnostic efficacy was assessed on the basis of image quality (5-stage scale from "excellent" to "very poor"), diagnosis and cytology test result. Safety was assessed on the basis of the frequency and seriousness of adverse drug reactions observed following the injection of Dotarem.

Study Type : Observational
Actual Enrollment : 1537 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
Study Start Date : September 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Image Quality [ Time Frame: During MRI procedure ]
    Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".

  2. Ability to Make a Diagnosis [ Time Frame: During MRI procedure ]
    Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?"

  3. Diagnostic Results (Percentage of Patients Per Diagnosis) [ Time Frame: During MRI procedure ]
    Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.

  4. Cytology Test Results (Percentage of Patients Per Cytology Test Result) [ Time Frame: During MRI procedure ]
    Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.

  5. Frequency of Adverse Drug Reactions [ Time Frame: From the beginning of the MR mammography procedure to 30-60 min after ]
    The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.



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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 who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem
Criteria

Inclusion Criteria:

  • Patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem

Exclusion Criteria:


Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT03041298     History of Changes
Other Study ID Numbers: DGD-55-006
First Posted: February 2, 2017    Key Record Dates
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No