Application of ihMT MRI in Multiple Sclerosis (ihMTMS)

Application of the Inhomogeneous Magnetisation Transfer MRI (ihMT) Technique, a New Myelin-specific MRI Technique, in Multiple Sclerosis

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.

Study Overview

• Status: Recruiting
• Conditions: Sclerosis, Multiple
• Intervention / Treatment: Device: inhomogeneous Magnetisation Transfer (ihMT) sequence; Device: inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T

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 Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JEAN PELLETIER, MD; Phone Number: +33 491388204; Email: Jean.PELLETIER@ap-hm.fr

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13354
      • Recruiting
      • Assistance Publique Des Hotipaux de Marseille
      • Contact: JEAN PELLETIER, MD; Phone Number: +33 491388204; Email: Jean.PELLETIER@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group 1.5T; Population of patients with myelin syndrome (MS) at the the disease onset with active lesions inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed.	Device: inhomogeneous Magnetisation Transfer (ihMT) sequence; robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T
Active Comparator: control group 1.5 T; healthy volunteers matched in sex and age inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed.	Device: inhomogeneous Magnetisation Transfer (ihMT) sequence; robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T
Experimental: experimental group 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.	Device: inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T; robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T
Active Comparator: control group 3T; inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed. inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T will be performed.	Device: inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T; robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ihMTR ratio at 3TMRI	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	1 year
Evaluate the predictive value of ihMT	Evaluate the predictive value of the measured dynamics with respect to the final progression of the lesions	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: EMILIE GARRIDO PRADALIE, APHM

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2018
• Primary Completion (Estimated): February 13, 2026
• Study Completion (Estimated): February 13, 2027

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2017-61 (CPP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No