3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal Cord Lesion in Multiple Sclerosis (WHINUME)

Multiple Sclerosis Clinical Trial

— WHINUME  

Official title:

3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal Cord Lesion in Multiple Sclerosis (WHINUME)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227092
• Other study ID #: CHUBX 2021/59
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: Vincent Dousset, MD, PhD
• Phone: +335 56 79 56 04
• Email: vincent.dousset[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• 3D OPTIMIZED WMN MPRAGE
At the cervical level the conventional data set: 2D Sagittal T2 FSE/ 2D Sagittal STIR / 2D Sagittal PSIR / 3D MPRAGE and the 3D OPTIMIZED MPRAGE WMN data set with sagittal and axial acquisition. At the thoracic level the conventional data set: 2D Sagittal T2 FSE/ 2D Sagittal STIR / 3D MPRAGE and the 3D Sagittal OPTIMIZED MPRAGE WMN data set.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lesions at the cervical level	number of lesions at the cervical level for the 3D optimized WMN MPRAGE sequence compared to "conventional sequences"	day 1
Secondary	lesions at the thoracic level	The number of lesions at the thoracic level for the 3D optimized WMN MPRAGE sequence compared to "conventional sequences"	day 1
Secondary	sensitivity of the 3D optimised WMN MPRAGE sequence	For the total number of lesions detected, the sensitivity of the 3D optimised WMN MPRAGE sequence compared to "conventional sequences".	day 1
Secondary	positive predictive value of the 3D optimized WMN MPRAGE sequence	For the total number of lesions detected and the positive predictive value of the 3D optimized WMN MPRAGE sequence compared to "conventional sequences	day 1
Secondary	Intraclass corelation coefficient	The reproducibility of the number of lesions will be assessed via two radiologists analysing the 3D WMN MPRAGE sequences and the "conventional sequences" twice	day 1
Secondary	pathogenicity of the lesions	Confidence in the pathogenicity of the lesions with a quantitative scale on each lesion detected at the cervical and thoracic level: 1) corresponding to a very low confidence, 2) moderate and 3) a very high confidence.	day 1
Secondary	presence of artefacts	The presence of artefacts at the cervical and thoracic level defined by a confidence scale: 1) corresponding to no artefacts, 2) minor artefacts, 3) moderate artefacts, 4) major artefacts, and 5) major artefacts	day 1
Secondary	volume of lesion	The volume (mm3) for 20 randomly selected patients, using a distinct, visible lesion at the cervical level to be detected on the "sequence of interest" and "conventional sequences".	day 1
Secondary	contrast-to-noise ratio	The contrast-to-noise ratio (CNR) calculated with [CNR = (Lesion Signal - Cord Signal) / Noise] for 20 randomly selected patients, using a distinct, visible lesion at the cervical level to be detected on the "sequence of interest" and "conventional sequences".	day 1
Secondary	patient's disability	The assessment of the patient's disability using the EDSS clinical scale (from 0-normal neurologic exam to 100-death).	day 1