Application of ihMT MRI in Multiple Sclerosis

Not Applicable

Recruiting

• Conditions: Sclerosis, Multiple
• Interventions: Device: inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T; Device: inhomogeneous Magnetisation Transfer (ihMT) sequence

• Registration Number: NCT03600779
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

The development of in vivo biomarkers sensitive to myelin disruption represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.

Detailed Description

The development of in vivo biomarkers sensitive to myelin disruption (demyelination and remyelination) represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.

Study Timeline

• Study Start: 2018-06-14
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2026-02-13
• Study Completion: 2027-02-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• For Patients and Controls :

  • Adult patient, male and female, age 18 to 45
  • Patient affiliated with health insurance coverage,
  • Patient who signed a free and informed consent after receiving detailed, understandable and honest information,

• For patients only :

  • Patient with relapsing-remitting multiple sclerosis according to the McDonald 2010 criteria
  • Disease duration of less than 5 years
  • Patients treated or not treated with first-line disease modifying therapy
  • Detection of at least one post-Gadolinium injection active lesion identified on the initial brain MRI (T0)

Exclusion Criteria

• For patients only :

  • Patients with a progressive form of MS other than the early relapsing-remitting form (primary progressive or secondary progressive)

• For Patients and Controls :

  • Patients with the usual contraindications for MRI (pacemaker, agitation, metal shards, claustrophobia)
  • Patients at risk of non-compliance to the exam: basic problems with understanding, confusion, involuntary movements, poor tolerance of prolonged supine position
  • Patients who are unable to give their consent: problems with understanding, lack of vigilance, confusion
  • Woman who is pregnant and breastfeeding
  • Patients with a history of neurological or psychiatric condition
  • Patients under guardianship or trusteeship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group 3T	inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T	Population of patients with myelin syndrome (MS) at the the disease onset with active lesions inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T will be performed.
control group 3T	inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T	inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed. inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T will be performed.
experimental group 1.5T	inhomogeneous Magnetisation Transfer (ihMT) sequence	Population of patients with myelin syndrome (MS) at the the disease onset with active lesions inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed.
control group 1.5 T	inhomogeneous Magnetisation Transfer (ihMT) sequence	healthy volunteers matched in sex and age inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed.

Primary Outcome Measures

Name	Time	Method
Magnetic transfert (MT) at 1.5TMRI	1 year	relative signal variations of the conventional magnetization transfer (MT)
ihMTR ratio at 1.5TMRI	1 year	ihMT 3D technique at 1.5TMRI on active lesions with baseline measurements
Myelin water fraction at 1.5TMRI	1 year	myelin water fraction (MWF), an MRI biomarker of myelin, in new MS lesions

Secondary Outcome Measures

Name	Time	Method
Evaluate the predictive value of ihMT	1 year	Evaluate the predictive value of the measured dynamics with respect to the final progression of the lesions
ihMTR ratio at 3TMRI	1 year	Relative variations in ihMTR ratio measured at 3T will be compared to those measured at 1.5T at the same points in time to opmtimize 3D ihMT technique at 3TMRI

Trial Locations

Locations (1)

Assistance Publique Des Hotipaux de Marseille; 🇫🇷 Marseille, Paca, France