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

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3D OPTIMIZED WMN MPRAGE
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring MS, MRI, CIS, RRMS, PPMS, MPRAGE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3D OPTIMIZED WMN MPRAGE

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

lesions at the thoracic level
The number of lesions at the thoracic level for the 3D optimized WMN MPRAGE sequence compared to "conventional sequences"
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".
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
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
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.
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
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".
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".
patient's disability
The assessment of the patient's disability using the EDSS clinical scale (from 0-normal neurologic exam to 100-death).

Full Information

First Posted
January 26, 2022
Last Updated
July 27, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05227092
Brief Title
3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal Cord Lesion in Multiple Sclerosis (WHINUME)
Acronym
WHINUME
Official Title
3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal Cord Lesion in Multiple Sclerosis (WHINUME)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
MS, MRI, CIS, RRMS, PPMS, MPRAGE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D OPTIMIZED WMN MPRAGE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
3D OPTIMIZED WMN MPRAGE
Intervention Description
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 Outcome Measure Information:
Title
lesions at the cervical level
Description
number of lesions at the cervical level for the 3D optimized WMN MPRAGE sequence compared to "conventional sequences"
Time Frame
day 1
Secondary Outcome Measure Information:
Title
lesions at the thoracic level
Description
The number of lesions at the thoracic level for the 3D optimized WMN MPRAGE sequence compared to "conventional sequences"
Time Frame
day 1
Title
sensitivity of the 3D optimised WMN MPRAGE sequence
Description
For the total number of lesions detected, the sensitivity of the 3D optimised WMN MPRAGE sequence compared to "conventional sequences".
Time Frame
day 1
Title
positive predictive value of the 3D optimized WMN MPRAGE sequence
Description
For the total number of lesions detected and the positive predictive value of the 3D optimized WMN MPRAGE sequence compared to "conventional sequences
Time Frame
day 1
Title
Intraclass corelation coefficient
Description
The reproducibility of the number of lesions will be assessed via two radiologists analysing the 3D WMN MPRAGE sequences and the "conventional sequences" twice
Time Frame
day 1
Title
pathogenicity of the lesions
Description
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.
Time Frame
day 1
Title
presence of artefacts
Description
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
Time Frame
day 1
Title
volume of lesion
Description
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".
Time Frame
day 1
Title
contrast-to-noise ratio
Description
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".
Time Frame
day 1
Title
patient's disability
Description
The assessment of the patient's disability using the EDSS clinical scale (from 0-normal neurologic exam to 100-death).
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Dousset, MD, PhD
Phone
+335 56 79 56 04
Email
vincent.dousset@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Amaury Ravache, MD
Email
amaury.ravache@chu-bordeaux.fr
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Dousset, Md, PhD
Email
vincent.dousset@chu-bordeaux.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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