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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Spinal Cord Injuries

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