Health TrialsbyHealthPanel

Application of ihMT MRI in Multiple Sclerosis

ConditionSclerosis, Multiple
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Patient with relapsing-remitting multiple sclerosis according to the McDonald 2010 criteria or progressive

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • inhomogeneous Magnetisation Transfer (ihMT) sequence

    Device

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

Treatment groups

85 Participants
are divided into 4 treatment groups
Group A: experimental group 1.5TExperimental treatment 1 intervention
Group B: control group 1.5 TActive comparator 1 intervention
Group C: experimental group 3TExperimental treatment 1 intervention
Group D: control group 3TActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ihMTR ratio at 1.5TMRI

ihMT 3D technique at 1.5TMRI on active lesions with baseline measurements

Time frame
1 year
2

Magnetic transfert (MT) at 1.5TMRI

relative signal variations of the conventional magnetization transfer (MT)

Time frame
1 year
3

Myelin water fraction at 1.5TMRI

myelin water fraction (MWF), an MRI biomarker of myelin, in new MS lesions

Time frame
1 year

Secondary outcomes

1

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

Time frame
1 year
2

Evaluate the predictive value of ihMT

Evaluate the predictive value of the measured dynamics with respect to the final progression of the lesions

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique Hopitaux De Marseille

Lead sponsor

Source ClinicalTrials.gov
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