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NCT04906928 Clinical Trial

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

Spinal Cord Injuries Clinical Trial

— ESPOIR2  

Official title:
Evaluation of the Performance of a 3D FGAPSIR Sequence by MRI in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04906928
Other study ID # ALR_2021_15
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date August 2024

Study information
Verified date December 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

- 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)

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date August 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• MRI
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)

Locations
Country Name City State
France Fondation Ophtalmologique Adolphe de Rothschild (FOR) 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 estimate the number of lesions detected with the 3D FGAPSIR sequence and not detected with the 3D PSIR sequence. estimate the number of lesions detected with the 3D FGAPSIR sequence and not detected with the 3D PSIR sequence. 1 DAY
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