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

Multiple Sclerosis Clinical Trial

— COPEQ-MS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04705870
• Other study ID #: JSY_2020_39
• Status: Active, not recruiting
• Start date: June 2, 2021
• Est. completion date: March 2, 2024

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2, 2024
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• cerebral MRI
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)

Locations

Country	Name	City	State
France	Hhopital fondation adolphe de rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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