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

MRI Clinical Trial

— CS-QSM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04907487
• Other study ID #: JSY_2021_13
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• MRI

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