Application of ihMT MRI in Multiple Sclerosis

NCT03600779 | Recruiting

• 1 other identifier: 2017-61
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Sclerosis, Multiple

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• ihMTR ratio at 3TMRI

  1 year

• Evaluate the predictive value of ihMT

  1 year

Study Arms (4)

experimental group 1.5T

EXPERIMENTAL

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

control group 1.5 T

ACTIVE COMPARATOR

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

Device: inhomogeneous Magnetisation Transfer (ihMT) sequence

experimental group 3T

EXPERIMENTAL

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

control group 3T

ACTIVE COMPARATOR

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

Interventions

inhomogeneous Magnetisation Transfer (ihMT) sequence DEVICE

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

control group 1.5 T; experimental group 1.5T

inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T DEVICE

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

control group 3T; experimental group 3T

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hotipaux de Marseille

Marseille, PACA, 13354, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Sequence Analysis, DNA

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

JEAN PELLETIER, MD

CONTACT

+33 491388204; Jean.PELLETIER@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 26, 2018
• Study Start: June 14, 2018
• Primary Completion: February 13, 2026
• Study Completion (Estimated): February 13, 2027
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

FR (1)