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

January 10, 2017 updated by: Guerbet
The main purpose of this study is to prospectively assess the general safety profile of Dotarem

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

35921

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires
  • Austria
      • Vienna, Austria
        • Diagnosticum Gersthof
  • China
      • Shanghai, China
        • Shanghai Pulmonary Hospital
  • France
      • Paris, France
        • Hôpital Necker
  • Germany
      • Cologne, Germany
        • Universitatskliniken
  • India
      • Mumbai, India
        • Bombay Hospital Institute of Medical Sciences
  • Italy
      • Verona, Italy
        • Ospedale Policlinico Giambattista Rossi
  • Saudi Arabia
      • Tabouk, Saudi Arabia
        • Tabouk Military Hospital
  • Spain
      • Lugo, Spain
        • Complexo Hospitalario Xeral-Calde
  • United Kingdom
      • Hull, United Kingdom
        • Hull Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nephrogenic Systemic Fibrosis Incidence
Time Frame: 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.
Follow-up of at least 3 months after magnetic resonance examination
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)
Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good.
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
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)
Diagnostic quality was assessed by the radiologist by answering the question "could you come to a diagnostic ?" (answer : yes or no).
Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (ESTIMATE)

February 1, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DGD-55-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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