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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01523873
First received: January 26, 2012
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
The main purpose of this study is to prospectively assess the general safety profile of Dotarem

Condition
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: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour) ] [ 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.

  • Diagnostic Quality [ Time Frame: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour) ] [ 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).


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)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Austria
Diagnosticum Gersthof
Vienna, Austria
China
Shanghai Pulmonary Hospital
Shanghai, China
France
Hôpital Necker
Paris, France
Germany
Universitätskliniken
Cologne, Germany
India
Bombay Hospital Institute of Medical Sciences
Mumbai, India
Italy
Ospedale Policlinico Giambattista Rossi
Verona, Italy
Saudi Arabia
Tabouk Military Hospital
Tabouk, Saudi Arabia
Spain
Complexo Hospitalario Xeral-Calde
Lugo, Spain
United Kingdom
Hull Royal Infirmary
Hull, United Kingdom
Sponsors and Collaborators
Guerbet
  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: April 14, 2016
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 July 28, 2016