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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02992847
• Other study ID #: 69HCL16_0646
• Status: Not yet recruiting
• Phase: N/A
• First received: October 19, 2016
• Last updated: December 12, 2016
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: Hospices Civils de Lyon
• Contact: Francçois COTTON, MD
• Phone: (0)4 78 86 21 37
• Email: francois.cotton[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Unenhanced MRI

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Guerbet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	EDSS (Expanded Disability Status Scale) score		12 months after last injection of contrast material for enhanced MR acquisition	No