Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-01-09 @ 11:06 PM
Study NCT ID:
NCT03048006
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-marketing Surveillance Study for Evaluation of Dotarem Safety
Sponsor:
Guerbet
Organization:
Study Overview
Official Title:
Evaluation of Dotarem Safety
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: