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

NCT05227092 | Recruiting

• 1 other identifier: CHUBX 2021/59
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

MS; MRI; CIS; RRMS; PPMS; MPRAGE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• lesions at the thoracic level

  day 1

• sensitivity of the 3D optimised WMN MPRAGE sequence

  day 1

• positive predictive value of the 3D optimized WMN MPRAGE sequence

  day 1

• Intraclass corelation coefficient

  day 1

• pathogenicity of the lesions

  day 1

Study Arms (1)

3D OPTIMIZED WMN MPRAGE

EXPERIMENTAL

* 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.

Device: 3D OPTIMIZED WMN MPRAGE

Interventions

3D OPTIMIZED WMN MPRAGE DEVICE

* 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.

3D OPTIMIZED WMN MPRAGE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Vincent Dousset, MD, PhD

CONTACT

+335 56 79 56 04; vincent.dousset@chu-bordeaux.fr

Amaury Ravache, MD

CONTACT

amaury.ravache@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: August 2, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)