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

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: NCT03041298
Recruitment Status : Completed
First Posted : February 2, 2017
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: MR Mammography With Dotarem
Intervention: Procedure: MR mammography with Dotarem

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
All Included Patients All included patients underwent MR mammography with Dotarem.

Participant Flow:   Overall Study
    All Included Patients
STARTED   1537 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
All Included Patients All included patients underwent MR mammography with Dotarem.

Baseline Measures
   All Included Patients 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
Participants Analyzed   1537 
   51.4  (12.3) 
Age, Customized 
[Units: Participants]
Count of Participants
<25 years   
Participants Analyzed   1537 
<25 years   8 
between 25 and 55 years   
Participants Analyzed   1537 
between 25 and 55 years   1025 
>55 years   
Participants Analyzed   1537 
>55 years   504 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
Participants Analyzed   1494 
Female      1491  99.8% 
Male      3   0.2% 
[1] Gender was missing for 43 patients.
Menopausal status [1] [2] 
[Units: Participants]
Count of Participants
Participants Analyzed   1506 
Premenopausal   506 
Participants Analyzed   1506 
Perimenopausal   174 
Participants Analyzed   1506 
Postmenopausal   826 
[1] Menopausal status was recorded before MR mammography.
[2] Menopausal status was missing for 31 patients.
Risk factors [1] [2] 
[Units: Participants]
Count of Participants
Family history   
Participants Analyzed   1267 
Family history   428 
Personal history   
Participants Analyzed   1267 
Personal history   525 
Family and personal history   
Participants Analyzed   1267 
Family and personal history   300 
Participants Analyzed   1267 
Other   14 
[1] Risk factors were recorded before MR mammography.
[2] Risk factors were missing for 270 patients.

  Outcome Measures

1.  Primary:   Image Quality   [ Time Frame: During MRI procedure ]

2.  Primary:   Ability to Make a Diagnosis   [ Time Frame: During MRI procedure ]

3.  Primary:   Diagnostic Results (Percentage of Patients Per Diagnosis)   [ Time Frame: During MRI procedure ]

4.  Primary:   Cytology Test Results (Percentage of Patients Per Cytology Test Result)   [ Time Frame: During MRI procedure ]

5.  Primary:   Frequency of Adverse Drug Reactions   [ Time Frame: From the beginning of the MR mammography procedure to 30-60 min after ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Oliver Heine, MD, Radiology & Scientific Affairs Manager
Organization: Guerbet GmbH
phone: +49 6196 76250

Responsible Party: Guerbet Identifier: NCT03041298     History of Changes
Other Study ID Numbers: DGD-55-006
First Submitted: February 1, 2017
First Posted: February 2, 2017
Results First Submitted: March 22, 2017
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017