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Application of ihMT MRI in Multiple Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 45 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03600779
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique Hopitaux De Marseille
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	EMILIE GARRIDO PRADALIE
Principal Investigator Affiliation	APHM
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sclerosis, Multiple

Additional Details

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.

Arms & Interventions

Arms

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.

Active Comparator: control group 1.5 T

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

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.

Active Comparator: control group 3T

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

Interventions

Device: - inhomogeneous Magnetisation Transfer (ihMT) sequence

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

Device: - inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Marseille, Paca, France

Status

Recruiting

Address

Assistance Publique Des Hotipaux de Marseille

Marseille, Paca, 13354

Site Contact

JEAN PELLETIER, MD

[email protected]

+33 491388204

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