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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT04907487

Collaborator

(none)

Enrollment

Location

11.5

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
MRI	Device: MRI

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)

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
SEP With Multiple Sclerosis as defined by McDonald's revised clinical or radiological spatial and temporal dissemination criteria	Device: MRI 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 For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease	Device: MRI 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)

Arm

Intervention/Treatment

SEP

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

Device: MRI

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

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

Device: MRI

Outcome Measures

Primary Outcome Measures

concordance of QSM signal with and without compressed-sensing in white matter [1 DAY]
concordance of QSM signal with and without compressed-sensing in white matter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hhopital fondation adolphe de rothschild	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04907487

Other Study ID Numbers:

JSY_2021_13

First Posted:

May 28, 2021

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 21, 2022