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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dotarem | At least 5 injection with Dotarem exclusively |
| |
| Multihance | At least 5 injection with Multihance exclusively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unenhanced MRI | Other |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| EDSS (Expanded Disability Status Scale) score | 12 months after last injection of contrast material for enhanced MR acquisition |
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Patients from the French observatory of multiple sclerosis (www.ofsep.org/)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francçois COTTON, MD | Contact | (0)4 78 86 21 37 | +33 | francois.cotton@chu-lyon.fr |
| Stéphane KREMER, MD | Contact | (0)3 88 12 78 93 | +33 |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |