Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)

Completed

• Conditions: General Safety Profile of DOTAREM

• Registration Number: NCT01523873
• Lead Sponsor: Guerbet

Brief Summary

The main purpose of this study is to prospectively assess the general safety profile of Dotarem

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2015-12-14
• Results First Submitted QC: 2015-12-14
• Results First Posted: 2016-01-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35921

Inclusion Criteria

• patient scheduled for a Dotarem®-enhanced MRI

Exclusion Criteria

• patient with a contra-indication to MR examination
• patient with a contra-indication to Dotarem® injection as per local SPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).	Adverse Events were notified and described.

Secondary Outcome Measures

Name	Time	Method
Nephrogenic Systemic Fibrosis Incidence	Follow-up of at least 3 months after magnetic resonance examination	For any patient identified with moderate to severe impaired renal function at the time of inclusion, a specific safety follow-up was performed in order to detect any suspicion of Nephrogenic Systemic Fibrosis.
Image Quality	Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)	Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good.
Diagnostic Quality	Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)	Diagnostic quality was assessed by the radiologist by answering the question "could you come to a diagnostic ?" (answer : yes or no).

Trial Locations

Locations (10)

Hôpital Necker; 🇫🇷 Paris, France

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina

Bombay Hospital Institute of Medical Sciences; 🇮🇳 Mumbai, India

Hull Royal Infirmary; 🇬🇧 Hull, United Kingdom

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China

Universitätskliniken; 🇩🇪 Cologne, Germany

Complexo Hospitalario Xeral-Calde; 🇪🇸 Lugo, Spain

Ospedale Policlinico Giambattista Rossi; 🇮🇹 Verona, Italy

Diagnosticum Gersthof; 🇦🇹 Vienna, Austria

Tabouk Military Hospital; 🇸🇦 Tabouk, Saudi Arabia