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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02992847

Enrollment

160

Registered

2016-12-14

Start date

2017-01-31

Completion date

2017-07-31

Last updated

2016-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Gadolinium based contrast agent, MRI, Dentate nucleus

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.

Interventions

OTHERUnenhanced MRI

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame	Description
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

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

Contacts

Primary ContactFrancçois COTTON, MD

francois.cotton@chu-lyon.fr(0)4 78 86 21 37

Backup ContactStéphane KREMER, MD

(0)3 88 12 78 93

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026