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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04707144
Acronym
ESPOIR1-5
Enrollment
106
Registered
2021-01-13
Start date
2021-05-06
Completion date
2023-06-28
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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).

Interventions

DEVICEMRI 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)

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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 sequence1 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)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)1 DAY
Describe the quality of the images in terms of artifacts for each of the sequences used (T1, T2, STIR and PSIR)1 DAY
Measure the signal-to-noise ratio of each of the sequences used (T1, T2, STIR and PSIR)1 DAY
Measure the inter-observer agreement on the number of lesions detected with the 3D PSIR sequence1 DAY
Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR sequence1 DAY

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026