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

• Conditions: Multiple Sclerosis
• Interventions: Other: Unenhanced MRI

• Registration Number: NCT02992847
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-12-12
• Last Update Submitted: 2016-12-12
• Study First Posted: 2016-12-14
• Last Update Posted: 2016-12-14
• Study Start: 2017-01
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

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Exclusion Criteria

• Never experienced other contrast agent then the one specified by the group to which they belong (either Dotarem, or Multihance)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dotarem	Unenhanced MRI	At least 5 injection with Dotarem exclusively
Multihance	Unenhanced MRI	At least 5 injection with Multihance exclusively

Primary Outcome Measures

Name	Time	Method
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)	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

Secondary Outcome Measures

Name	Time	Method
EDSS (Expanded Disability Status Scale) score	12 months after last injection of contrast material for enhanced MR acquisition