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Recruiting NCT03600779

Application of ihMT MRI in Multiple Sclerosis

No phase Interventional Sclerosis, Multiple

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: inhomogeneous Magnetisation Transfer (ihMT) sequence, inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T.
Who it may be relevant to
Registry conditions: Sclerosis, Multiple. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Primary outcome measures

  • ihMTR ratio at 1.5TMRI [Time frame: 1 year]
  • Magnetic transfert (MT) at 1.5TMRI [Time frame: 1 year]
  • Myelin water fraction at 1.5TMRI [Time frame: 1 year]
Secondary outcome measures (2)
  • ihMTR ratio at 3TMRI [Time frame: 1 year]
  • Evaluate the predictive value of ihMT [Time frame: 1 year]

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 or progressive
  • 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) or a chronic active lesion (PRL: Paramagnetic rim lesions)

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Assistance Publique Des Hotipaux de Marseille — Marseille

Identifiers

NCT: NCT03600779 · 2017-61

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗