Evaluation of Potential Accumulation of Gadolinium (Dotarem and Multihance) in the French Observatory of Multiple Sclerosis (Www.Ofsep.Org/)

December 12, 2016 updated by: Hospices Civils de Lyon
Several recent studies have shown an increase in the signal intensity of the unenhanced T1-weighted magnetic resonance images in the brain of patients with normal renal functions and a breakdown of the blood-brain barrier. This hyper-intensity was specifically related to an accumulation of gadolinium based contrast agent. These studies were mainly conducted in patients with primary or secondary brain tumor. Multiple sclerosis is a particular model since it involves patients with a break of the blood-brain barrier, a long life expectancy, and who received many injections of contrast enhancing agents. In this context, it appears fundamental to know whether contrast agents accumulate in the brain for this disease. The French Observatory of Multiple Sclerosis is particularly suited to test this hypothesis, with homogeneous MRI data over several centers in France, and optimized sequences of 3D-T1 without injection. The purpose of this study is to evaluate the accumulation of two commonly used gadolinium based contrast materials (Dotarem and Multihance) in patients with multiple sclerosis, who received at least 5 injection of exclusively one of these contrast material.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the French observatory of multiple sclerosis (www.ofsep.org/)

Description

  • Inclusion Criteria:
  • Clinical diagnosis of Multiple sclerosis
  • At least 5 MR imaging with the same Gadolinium based contrast agent (either Dotarem or Multihance)
  • Have performed an unenhanced T1-weighted image before Gadolinium based contrast agent injection according to the OFSEP protocol
  • Exclusion Criteria:
  • Never experienced other contrast agent then the one specified by the group to which they belong (either Dotarem, or Multihance)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dotarem
At least 5 injection with Dotarem exclusively
Other: Unenhanced MRI
Multihance
At least 5 injection with Multihance exclusively
Other: Unenhanced MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean signal intensity in the dentate nucleus, pons, globus pallidus, and thalamus on unenhanced T1-weighted images after unenhanced MRI (magnetic resonance imaging), (no measurement unit)
Time Frame: 12 months after last injection of contrast material for enhanced MR acquisition
Operator defined region of interest measure of signal intensity on unenhanced T1-weighted images after MR acquisition
12 months after last injection of contrast material for enhanced MR acquisition

Secondary Outcome Measures

Outcome Measure
Time Frame
EDSS (Expanded Disability Status Scale) score
Time Frame: 12 months after last injection of contrast material for enhanced MR acquisition
12 months after last injection of contrast material for enhanced MR acquisition

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Collaborators

Guerbet

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

January 1, 2017

Primary Completion (ANTICIPATED)

July 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (ESTIMATE)

December 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0646

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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