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Clinical Trials/NCT04707144
NCT04707144CompletedNot Applicable

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

Fondation Ophtalmologique Adolphe de Rothschild6 sites in 1 country106 target enrollmentStarted: May 6, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
106
Locations
6
Primary Endpoint
Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR sequence

Study Overview

Brief 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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR sequence

Time Frame: 1 DAY

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)

Time Frame: 1 day

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)

Time Frame: 1 DAY

Measure the signal-to-noise ratio of each of the sequences used (T1, T2, STIR and PSIR)

Time Frame: 1 DAY

Measure the inter-observer agreement on the number of lesions detected with the 3D PSIR sequence

Time Frame: 1 DAY

Describe the quality of the images in terms of artifacts for each of the sequences used (T1, T2, STIR and PSIR)

Time Frame: 1 DAY

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

Time Frame: 1 DAY

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (6)

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