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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.
ClinicalTrials.gov Identifier: NCT03048006
Recruitment Status : Completed
First Posted : February 9, 2017
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Contrast-enhanced MRI With Dotarem
Intervention: Procedure: MRI 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
No text entered.

Reporting Groups
  Description
All Included Patients All included patients underwent MRI with Dotarem

Participant Flow:   Overall Study
    All Included Patients
STARTED   44456 
COMPLETED   44456 
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 MRI with Dotarem

Baseline Measures
   All Included Patients 
Overall Participants Analyzed 
[Units: Participants]
 44456 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 44289 
   52.3  (16.9) 
[1] Age was missing for 167 patients.
Age, Customized [1] 
[Units: Participants]
Count of Participants
 
<2 years   
Participants Analyzed 
[Units: Participants]
 44289 
<2 years   1 
between 2 and 11 years   
Participants Analyzed 
[Units: Participants]
 44289 
between 2 and 11 years   81 
between 12 and 17 years   
Participants Analyzed 
[Units: Participants]
 44289 
between 12 and 17 years   617 
≥18 years   
Participants Analyzed 
[Units: Participants]
 44289 
≥18 years   43590 
[1] Age was missing for 167 patients.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 43769 
Female      24254  55.4% 
Male      19515  44.6% 
[1] Gender was missing for 687 patients.
Risk factors [1] [2] 
[Units: Participants]
Count of Participants
 
Known allergies   
Participants Analyzed 
[Units: Participants]
 44456 
Known allergies   6871 
History of a reaction to a contrast agent   
Participants Analyzed 
[Units: Participants]
 44456 
History of a reaction to a contrast agent   176 
Bronchial asthma   
Participants Analyzed 
[Units: Participants]
 44456 
Bronchial asthma   630 
Beta-blocker treatment   
Participants Analyzed 
[Units: Participants]
 44456 
Beta-blocker treatment   648 
Coronary heart disease   
Participants Analyzed 
[Units: Participants]
 44456 
Coronary heart disease   824 
Heart failure   
Participants Analyzed 
[Units: Participants]
 44456 
Heart failure   413 
Hypertension   
Participants Analyzed 
[Units: Participants]
 44456 
Hypertension   2479 
Liver dysfunction   
Participants Analyzed 
[Units: Participants]
 44456 
Liver dysfunction   121 
Central nervous system disorders   
Participants Analyzed 
[Units: Participants]
 44456 
Central nervous system disorders   560 
Other   
Participants Analyzed 
[Units: Participants]
 44456 
Other   858 
[1] Risk factors were recorded before the MRI examination
[2] Out of the 44,456 patients, 11,006 showed at least one risk factor. Several risk factors could be reported for the same patient.


  Outcome Measures

1.  Primary:   Frequency of Adverse Events   [ Time Frame: From the beginning of the MRI procedure to 30–60 min after ]

2.  Secondary:   Diagnostic Value   [ Time Frame: During MRI procedure ]

3.  Secondary:   Image Quality   [ Time Frame: During MRI procedure ]


  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: NCT03048006     History of Changes
Other Study ID Numbers: DGD-55-005
First Submitted: February 1, 2017
First Posted: February 9, 2017
Results First Submitted: March 22, 2017
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017