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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Unenhanced MRI


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dotarem<br>At least 5 injection with Dotarem exclusively | Other: Unenhanced MRI<br> <br> |
| Multihance<br>At least 5 injection with Multihance exclusively | Other: Unenhanced MRI<br> <br> |

What is the study measuring?
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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) | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| EDSS (Expanded Disability Status Scale) score |  | 12 months after last injection of contrast material for enhanced MR acquisition | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, MRI, Gadolinium based contrast agent, Dentate nucleus