Status:
COMPLETED
Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)
Lead Sponsor:
Guerbet
Conditions:
General Safety Profile of DOTAREM
Eligibility:
All Genders
Brief Summary
The main purpose of this study is to prospectively assess the general safety profile of Dotarem
Eligibility Criteria
Inclusion
- patient scheduled for a Dotarem®-enhanced MRI
Exclusion
- patient with a contra-indication to MR examination
- patient with a contra-indication to Dotarem® injection as per local SPC
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
35921 Patients enrolled
Trial Details
Trial ID
NCT01523873
Start Date
November 1 2008
End Date
July 1 2013
Last Update
February 24 2017
Active Locations (10)
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1
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
2
Diagnosticum Gersthof
Vienna, Austria
3
Shanghai Pulmonary Hospital
Shanghai, China
4
Hôpital Necker
Paris, France