Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05227092

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, France

Location status: Recruiting

Location contact

Vincent Dousset, Md, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. lesions at the cervical level

    Time frame: day 1

    number of lesions at the cervical level for the 3D optimized WMN MPRAGE sequence compared to "conventional sequences"

Secondary outcomes

  1. lesions at the thoracic level

    Time frame: day 1

    The number of lesions at the thoracic level for the 3D optimized WMN MPRAGE sequence compared to "conventional sequences"

  2. sensitivity of the 3D optimised WMN MPRAGE sequence

    Time frame: day 1

    For the total number of lesions detected, the sensitivity of the 3D optimised WMN MPRAGE sequence compared to "conventional sequences".

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

    Time frame: day 1

    For the total number of lesions detected and the positive predictive value of the 3D optimized WMN MPRAGE sequence compared to "conventional sequences

  4. Intraclass corelation coefficient

    Time frame: day 1

    The reproducibility of the number of lesions will be assessed via two radiologists analysing the 3D WMN MPRAGE sequences and the "conventional sequences" twice

  5. pathogenicity of the lesions

    Time frame: day 1

    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.

  6. presence of artefacts

    Time frame: day 1

    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

  7. volume of lesion

    Time frame: day 1

    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".

  8. contrast-to-noise ratio

    Time frame: day 1

    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".

  9. patient's disability

    Time frame: day 1

    The assessment of the patient's disability using the EDSS clinical scale (from 0-normal neurologic exam to 100-death).

Study contacts

Contact information is provided by the study sponsor or research team.

Amaury Ravache, MD

CONTACT

[email protected]

Vincent Dousset, MD, PhD

CONTACT

[email protected]

+335 56 79 56 04

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: WHINUME

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2022
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.