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

March 22, 2017 updated by: Guerbet

Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All included patients
All included patients underwent MR mammography with Dotarem
Procedure: MR mammography with Dotarem
Other Names:
  • MR mammography with gadoteric acid/gadoterate meglumine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Quality
Time Frame: During MRI procedure
Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".
During MRI procedure
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 ?"
During MRI procedure
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.
During MRI procedure
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.
During MRI procedure
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.
From the beginning of the MR mammography procedure to 30-60 min after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGD-55-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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