Evaluation of New MRI Sequences Including 3D-FGAPSIR for the Optimization of Inflammatory Spinal Cord Lesions Research

Recruiting

• Conditions: Spinal Cord Injuries

• Registration Number: NCT04906928
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

* verification of inclusion and non-inclusion criteria

* information and collection of consent

* standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.

* 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

Detailed Description

* verification of inclusion and non-inclusion criteria

* information and collection of consent

* standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.

* 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Study Start: 2023-10-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patient over 18 years old
• To benefit from a medullary exploration planned by 3T MRI as part of a first evaluation or a reassessment of inflammatory involvement of the nevrax
• Express consent to participate in the study
• Affiliate or beneficiary of a social security scheme

Exclusion Criteria

• Patient benefiting from a legal protection measure
• Pregnant, parturient or breastfeeding woman
• Absolute or relative contraindication to MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
estimate the number of lesions detected with the 3D FGAPSIR sequence and not detected with the 3D PSIR sequence.	1 DAY	estimate the number of lesions detected with the 3D FGAPSIR sequence and not detected with the 3D PSIR sequence.

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild (FOR); 🇫🇷 Paris, France