Application of ihMT MRI in Multiple Sclerosis

NCT ID: NCT03600779

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-14
• Study Completion Date: 2027-02-13

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.

Conditions

Sclerosis, Multiple

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

inhomogeneous Magnetisation Transfer (ihMT) sequence

Intervention Type: DEVICE

robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T

control group 1.5 T

healthy volunteers matched in sex and age inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed.

Group Type: ACTIVE_COMPARATOR

inhomogeneous Magnetisation Transfer (ihMT) sequence

Intervention Type: DEVICE

robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T

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.

Group Type: EXPERIMENTAL

inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T

Intervention Type: DEVICE

robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T

control group 3T

inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed. inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T will be performed.

Group Type: ACTIVE_COMPARATOR

inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T

Intervention Type: DEVICE

robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T

Interventions

inhomogeneous Magnetisation Transfer (ihMT) sequence

robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T

Intervention Type: DEVICE

inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T

robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EMILIE GARRIDO PRADALIE

Role: STUDY_DIRECTOR

APHM

Locations

Assistance Publique Des Hotipaux de Marseille

Marseille, PACA, France

Site Status: RECRUITING

Countries

France

Central Contacts

JEAN PELLETIER, MD

Role: CONTACT

Jean.PELLETIER@ap-hm.fr

+33 491388204

Facility Contacts

JEAN PELLETIER, MD

Role: primary

Jean.PELLETIER@ap-hm.fr

+33 491388204

Other Identifiers

2017-61

Identifier Type: -

Identifier Source: org_study_id