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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

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
No text entered.

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
  Description
All Included Patients All included patients underwent MR mammography with Dotarem.

Participant Flow:   Overall Study
    All Included Patients
STARTED   1537 
COMPLETED   1537 
NOT COMPLETED   0 



  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.
No text entered.

Reporting Groups
  Description
All Included Patients All included patients underwent MR mammography with Dotarem.

Baseline Measures
   All Included Patients 
Overall Participants Analyzed 
[Units: Participants]
 1537 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 1537 
   51.4  (12.3) 
Age, Customized 
[Units: Participants]
Count of Participants
 
<25 years   
Participants Analyzed 
[Units: Participants]
 1537 
<25 years   8 
between 25 and 55 years   
Participants Analyzed 
[Units: Participants]
 1537 
between 25 and 55 years   1025 
>55 years   
Participants Analyzed 
[Units: Participants]
 1537 
>55 years   504 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 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
 
Premenopausal   
Participants Analyzed 
[Units: Participants]
 1506 
Premenopausal   506 
Perimenopausal   
Participants Analyzed 
[Units: Participants]
 1506 
Perimenopausal   174 
Postmenopausal   
Participants Analyzed 
[Units: Participants]
 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 
[Units: Participants]
 1267 
Family history   428 
Personal history   
Participants Analyzed 
[Units: Participants]
 1267 
Personal history   525 
Family and personal history   
Participants Analyzed 
[Units: Participants]
 1267 
Family and personal history   300 
Other   
Participants Analyzed 
[Units: Participants]
 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
No text entered.


  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
e-mail: oliver.heine@guerbet-group.com



Responsible Party: Guerbet
ClinicalTrials.gov 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