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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04907487
Other study ID # JSY_2021_13
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2021
Est. completion date April 27, 2025

Study information

Verified date July 2023
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact amélie YAVCHITZ
Phone 0148036454
Email ayavchitz@for.paris
Is FDA regulated No
Health authority
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 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)


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 27, 2025
Est. primary completion date June 27, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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)

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 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
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