Comparison of the Performance of an Optimized 3D EPI SWI Sequence and a Non-EPI QSM SWI Sequence in Detecting the Central Vein Sign in Patients With Multiple Sclerosis (COPEQ-MS)

Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which four additional 20-minute sequences will be added.

MRI of routine care in the context of MS includes at least the following sequences:

• 3D T1 TFE (2 minutes)
• T2 TSE (2 minutes)
• 3D FLAIR (3 minutes)
• SWI EPI 0.6 iso (7 minutes)

The sequences added by the search are:

• SWI non EPI QSM 6 echo (10 minutes)
• SWI EPI in resolution equivalent to non-EPI SWI (3 minutes)
• SWI EPI to TR equivalent to SWI non EPI (6 minutes)

These sequences will be acquired before or after the injection of gadolinium (if present in the examination of routine care). For examinations carried out with injection, the order of carrying out the 4 post-injection SWI sequences will be random.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: cerebral MRI

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Hhopital fondation adolphe de rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with MS and who should undergo an MRI examination with or without injections of contrast agent as part of their care.

Description

Inclusion Criteria:

• Patients over 18
• With MS defined according to the McDonald's revised clinical or radiological spatial and temporal dissemination criteria, with onset of symptoms <5 years
• To benefit as part of care from an MRI with or without injection of gadolinium
• Express consent to participate in the study
• Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

• Patient benefiting from a legal protection measure
• Pregnant or breastfeeding woman

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of lesions showing the central vein sign with the SWI EPI sequence that also show the central vein sign with the candidate sequence	1 day
percentage of lesions which do not present the sign of the central vein with the SWI EPI sequence but which present it with the candidate sequence	1 day

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Actual): May 24, 2023
• Study Completion (Estimated): March 2, 2024

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: JSY_2020_39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No