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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: January 26, 2012
Last updated: December 14, 2015
Last verified: October 2013
The main purpose of this study is to prospectively assess the general safety profile of Dotarem

General Safety Profile of DOTAREM®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Frequency of Adverse Events [ Time Frame: During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination). ] [ Designated as safety issue: Yes ]
    Adverse Events were notified and described.

Secondary Outcome Measures:
  • Nephrogenic Systemic Fibrosis Incidence [ Time Frame: Follow-up of at least 3 months after magnetic resonance examination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: During magnetic resonance examination. ] [ Designated as safety issue: No ]
    Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good. Data were missing for 164 patients.

  • Diagnostic Quality [ Time Frame: During magnetic resonance examination ] [ Designated as safety issue: No ]
    Diagnostic quality was assessed by the radiologist by answering the question "could you come to a diagnostic ?" (answer : yes or no). Data were missing for 308 patients.

Enrollment: 35921
Study Start Date: November 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients scheduled for a Dotarem®-enhanced MRI over a one year period at each participating radiological site

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01523873

Roissy CdG, France, 95943
Sponsors and Collaborators
  More Information

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01523873     History of Changes
Other Study ID Numbers: DGD-55-001 
Study First Received: January 26, 2012
Results First Received: December 14, 2015
Last Updated: December 14, 2015
Health Authority: Argentina: Ministry of Health
Argentina: Ethics Commitee
China: Ethics Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil National de l'Ordre des Médecins
France: The Commission nationale de l’informatique et des libertés
Germany: Federal Institute for Drugs and Medical Devices
India: Institutional Review Board
Italy: Ethics Committee
Saudi Arabia: Ethics Committee
Spain: Ethics Committee
Spain: Spanish Agency of Medicines

ClinicalTrials.gov processed this record on April 27, 2016