Post-marketing Surveillance Study for Evaluation of Dotarem Safety

Contrast-enhanced MRI With Dotarem Clinical Trial

Official title:

Evaluation of Dotarem Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048006
• Other study ID #: DGD-55-005
• Status: Completed
• Phase: N/A
• First received: February 1, 2017
• Last updated: February 7, 2017
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2017
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.

Description:

Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44456
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

• Patients undergoing routine MRI using the MRI contrast medium Dotarem

Exclusion Criteria:

Related Conditions & MeSH terms

• Contrast-enhanced MRI With Dotarem

Intervention

Procedure:
• MRI with Dotarem

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events		From the beginning of the MRI procedure to 30-60 min after
Secondary	Diagnostic value	Diagnostic value was evaluated by answering "yes" or "no" to the following question "Were you able to make a diagnosis based on the test results ?"	During MRI procedure
Secondary	Image quality	Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "average"; "poor" and "very poor")	During MRI procedure