Évaluation de l'Impact du Compressed Sensing Sur le Signa... | NCT04907487

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

NCT04907487

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Jan 5, 2026Actual

Enrollment

82Actual

Phase

Not provided

Conditions

Interventions

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2021Actual

Primary Completion Date

May 14, 2025Actual

Completion Date

May 14, 2025Actual

First Submitted Date

May 25, 2021

First Submission Date that Met QC Criteria

May 25, 2021

First Posted Date

May 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2025

Last Update Posted Date

Jan 5, 2026Actual

Description Module

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)

Detailed Description

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Secondary exclusion criteria :

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample