N/A
N=1,537
Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
MR Mammography With Dotarem
Bottom Line
View on ClinicalTrials.gov: NCT03041298 ↗Enrolled (actual)
1,537
Serious AEs
0.1%
Results posted
May 2017
Primary outcome: Primary: Image Quality — 495; 898; 118; 8 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- MR mammography with Dotarem (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Image Quality |
495; 898; 118; 8; 2 | — |
| PRIMARY Ability to Make a Diagnosis |
1523; 12 | — |
| PRIMARY Diagnostic Results (Percentage of Patients Per Diagnosis) |
858; 324; 159; 101; 72; 23 | — |
| PRIMARY Cytology Test Results (Percentage of Patients Per Cytology Test Result) |
109; 66; 35; 14; 8; 3 | — |
| PRIMARY Frequency of Adverse Drug Reactions |
12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT03041298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.