Clinical trial NCT04707144: Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-01-13
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be offered prospectively to patients presenting to the imaging department for a 1.5T MRI for bone marrow exploration, in the context of inflammatory involvement of the nevrax

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 DAY
measure: 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)
timeFrame: 1 day
measure: 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)
timeFrame: 1 DAY
measure: Describe the quality of the images in terms of artifacts for each of the sequences used (T1, T2, STIR and PSIR)
timeFrame: 1 DAY
measure: Measure the signal-to-noise ratio of each of the sequences used (T1, T2, STIR and PSIR)
timeFrame: 1 DAY
measure: Measure the inter-observer agreement on the number of lesions detected with the 3D PSIR sequence
timeFrame: 1 DAY
measure: Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR sequence
timeFrame: 1 DAY
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU DE Bordeaux
city: Clermont-ferrand
country: France
facility: Chu de Clermont-Ferrand
city: Lille
country: France
facility: Chu de Lille
city: Lyon
country: France
facility: CHU de LYON
city: Paris
country: France
facility: Hôpital privé des Peupliers
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Study officials:
References: