Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T

Multiple Sclerosis Clinical Trial

— ESPOIR1-5  

Official title:

Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707144
• Other study ID #: ALR_2020_40
• Status: Completed
• Start date: May 6, 2021
• Est. completion date: June 28, 2023

Study information

• Verified date: December 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Inclusion visit (D0):

• 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), o 3D STIR sequence.

• 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 28, 2023
• Est. primary completion date: June 6, 2023
• 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 MRI 1.5T as part of a first evaluation or a re-evaluation 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

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• MRI 1.5 tesla
standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence. 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes)

Locations

Country	Name	City	State
France	CHU DE Bordeaux	Bordeaux
France	Chu de Clermont-Ferrand	Clermont-ferrand
France	Chu de Lille	Lille
France	CHU de LYON	Lyon
France	Fondation Ophtalmologique Adolphe de Rothschild (FOR)	Paris
France	Hôpital privé des Peupliers	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 spinal cord injuries detected with the set of standard sequences (T1, T2 and STIR) that are not detected with the 3D PSIR sequence		1 DAY
Primary	Estimate the number of active lesions taking the contrast after injection of gadolinium, with the 3D PSIR sequence which is not detected in the set of standard sequences (T1, T2 and STIR)		1 day
Primary	Compare the diagnostic confidence expressed by the radiologist for the detection of spinal cord injuries with the 3D PSIR sequence compared to the set of standard sequences (T1, T2 and STIR)		1 DAY
Primary	Describe the quality of the images in terms of artifacts for each of the sequences used (T1, T2, STIR and PSIR)		1 DAY
Primary	Measure the signal-to-noise ratio of each of the sequences used (T1, T2, STIR and PSIR)		1 DAY
Primary	Measure the inter-observer agreement on the number of lesions detected with the 3D PSIR sequence		1 DAY
Primary	Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR sequence		1 DAY