Clinical trial NCT05227092: 3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal Cord Lesion in Multiple Sclerosis (WHINUME)
Official title: 3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal Cord Lesion in Multiple Sclerosis (WHINUME)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: MS
MRI
CIS
RRMS
PPMS
MPRAGE
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the 3D OPTIMIZED MPRAGE WMN sequence to "conventional sequences" used in spinal cord analysis.

The patients will be explored at the cervical level with the conventional 2D sagittal T2 FSE, 2D sagittal STIR, 2D sagittal PSIR, 3D T1 MPRAGE sequences, and the sequence of interest 3D sagittal OPTIMIZED WMN MPRAGE and 3D axial OPTIMIZED WMN MPRAGE. At the thoracic level, with the conventional 2D sagittal T2 FSE, 2D sagittal STIR, 3D T1 MPRAGE sequences and the sequence of interest 3D sagittal OPTIMIZED WMN MPRAGE.

Detailed description: Multiple sclerosis is a common inflammatory disease of the central nervous system and the leading cause of non-traumatic physical disability in young adults.

Spinal cord involvement is common, affecting approximately 90% of patients, and can be revealed by sensory loss, neuropathic pain, spasticity, motor weakness, and bladder and bowel dysfunction. Spinal cord imaging plays an important role in the diagnosis of the disease, but also in the prognosis, particularly with regard to the location and severity of the damage.

Due to the location, small size and mobility of the spinal cord, its imaging raises technical problems and fewer studies have focused on spinal cord involvement in MS than on brain involvement.

Currently, the 2D sagittal T2 FSE sequence is the imaging of choice for spinal cord analysis. Numerous sequences have been developed recently, some of which show an increase in sensitivity at the cervical level, such as short tau inversion recovery (STIR) and phase sensitive inversion recovery (PSIR). The lesion load assessed on these conventional sequences lacks correlation with clinical status, probably due to a multifactorial mechanism of disability in MS, but also probably due to the limitations of the resolution of current sequences.

WHINUME study will investigate at the spinal cord level the interest of an optimised MP-RAGE sequence cancelling the spinal cord white matter signal. The hypothesis is that this sequence could have a good sensitivity, specificity and reproducibility between readers for the detection of spinal cord lesions compared to other sequences at the cervical level but also at the thoracic level. Therefore, it could replace the conventional sequences currently available.

This study will prospectively include 60 patients with multiple sclerosis confirmed by the McDonald 2017 criteria. All patients will sign a consent form. The 3D OPTIMIZED MPRAGE WMN will be compared to conventional sequences.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* CIS or RRMS
* Medullary symptomatology less than 6 months
* With or without an objective lesion on a subsequent MRI scan
* Signed the Informed Consent

Exclusion Criteria:

* Pregnant or potentially pregnant women
* Breastfeeding woman
* Contraindications to MRI
* Other diagnosis (Neuro-myelitis spectrum disease or Progressive Multiple Sclerosis)
* Surgical history on the spinal cord or lumbar spine
* Patient under legal protection

Primary outcomes:
measure: lesions at the cervical level
timeFrame: day 1
Secondary outcomes:
measure: lesions at the thoracic level
timeFrame: day 1
measure: sensitivity of the 3D optimised WMN MPRAGE sequence
timeFrame: day 1
measure: positive predictive value of the 3D optimized WMN MPRAGE sequence
timeFrame: day 1
measure: Intraclass corelation coefficient
timeFrame: day 1
measure: pathogenicity of the lesions
timeFrame: day 1
measure: presence of artefacts
timeFrame: day 1
measure: volume of lesion
timeFrame: day 1
measure: contrast-to-noise ratio
timeFrame: day 1
measure: patient's disability
timeFrame: day 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: