Trials / Completed
CompletedNCT03041298
Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,537 (actual)
- Sponsor
- Guerbet · Industry
- Sex
- All
- Age
- 100 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | MR mammography with Dotarem |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2013-10-01
- Completion
- 2013-12-01
- First posted
- 2017-02-02
- Last updated
- 2017-05-02
- Results posted
- 2017-05-02
Source: ClinicalTrials.gov record NCT03041298. Inclusion in this directory is not an endorsement.