Application of ihMT MRI in Multiple Sclerosis

Sclerosis, Multiple Clinical Trial

— ihMTMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03600779
• Other study ID #: 2017-61
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2018
• Est. completion date: June 14, 2025

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: JEAN PELLETIER, MD
• Phone: +33 491388204
• Email: Jean.PELLETIER[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: June 14, 2025
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Sclerosis, Multiple

Intervention

Device:
• inhomogeneous Magnetisation Transfer (ihMT) sequence
robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T
• inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T
robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T

Locations

Country	Name	City	State
France	Assistance Publique Des Hotipaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

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