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

NCT04705870 | Completed

• 1 other identifier: JSY_2020_39
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

cerebral MRI DEVICE

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hhopital fondation adolphe de rothschild

Paris, Paris, 75019, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 12, 2021
• Study Start: June 2, 2021
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)