Évaluation de l'Impact du Compressed Sensing Sur le Signal QSM

NCT04907487 | Completed

• 1 other identifier: JSY_2021_13
• Study Type: observational
• Target: 82
• 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 a maximum of four additional 25-minute sequences will be added. MRI of routine care includes at least the following sequences:

• 3D T1 TFE (2 minutes)
• T2 TSE (2 minutes)
• 3D FLAIR (3 minutes) The sequences added by the research lasting 25 minutes are:
• SWI QSM 1.0iso 8 echoes (10 minutes)
• SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
• SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
• SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)

Conditions

MRI

Outcome Measures

Primary Outcomes (1)

• concordance of QSM signal with and without compressed-sensing in white matter

  concordance of QSM signal with and without compressed-sensing in white matter

  1 DAY

Study Arms (2)

SEP

With Multiple Sclerosis as defined by McDonald's revised clinical or radiological spatial and temporal dissemination criteria

Device: MRI

NO SEP

For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease

Device: MRI

Interventions

MRI DEVICE

MRI of routine care includes at least the following sequences: * 3D T1 TFE (2 minutes) * T2 TSE (2 minutes) * 3D FLAIR (3 minutes) The sequences added by the research lasting 25 minutes are: * SWI QSM 1.0iso 8 echoes (10 minutes) * SWI QSM 1.0iso 8 echoes CS 6 (7 minutes) * SWI QSM 1.0iso 8 echoes CS 9 (5 minutes) * SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)

NO SEP; SEP

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

Two groups of patients will be included as part of this research protocol: * Group I: Patients with MS * Group II: Patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS pathology, age and gender matched with group I.

You may qualify if:

• For patients with MS:
• Patient over 18 years old
• Presenting MS defined according to McDonald's revised criteria for spatial and temporal clinical or radiological dissemination \[16\],
• Should benefit as part of the care of an MRI examination with or without injection of gadolinium
• Express consent to participate in the study
• Affiliate or beneficiary of a social security scheme
• For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease:
• Patient over 18 years old
• Should benefit as part of the care of an MRI examination 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:

• For patients with MS:
• Patient benefiting from a legal protection measure
• Pregnant or breastfeeding woman
• For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease:
• Patient benefiting from a legal protection measure
• Pregnant or breastfeeding woman
• Patient with inflammatory and / or demyelinating pathology of the CNS
• Motion artefact not allowing interpretation of images
• Patient who did not perform one of the following sequences: 3D T1 TFE, 3D FLAIR (for MS patients), SWI QSM 1.0iso 8 echoes.
• Secondarily excluded patients will be replaced.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hhopital fondation adolphe de rothschild

Paris, Paris, 75019, France

Location

Study Design

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

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: December 15, 2021
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

FR (1)