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

NCT ID: NCT02992847

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-07-31

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.

Detailed Description

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Conditions

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Multiple Sclerosis

Keywords

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Multiple sclerosis Gadolinium based contrast agent MRI Dentate nucleus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dotarem

At least 5 injection with Dotarem exclusively

Unenhanced MRI

Intervention Type OTHER

Multihance

At least 5 injection with Multihance exclusively

Unenhanced MRI

Intervention Type OTHER

Interventions

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Unenhanced MRI

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guerbet

INDUSTRY

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Francçois COTTON, MD

Role: CONTACT

Phone: (0)4 78 86 21 37

Email: [email protected]

Stéphane KREMER, MD

Role: CONTACT

Phone: (0)3 88 12 78 93

Other Identifiers

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69HCL16_0646

Identifier Type: -

Identifier Source: org_study_id