Sclerosis, MultipleihMTMSNCT03600779
Application of ihMT MRI in Multiple Sclerosis
A study testing inhomogeneous Magnetisation Transfer (ihMT) sequence and inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T in people with Sclerosis, Multiple, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sclerosis, Multiple
- What is being tested?
- inhomogeneous Magnetisation Transfer (ihMT) sequence and inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2018to 14 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- Woman who is pregnant and breastfeeding
- Patients with a history of neurological or psychiatric condition
- Patients under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Des Hotipaux de Marseille
Marseille, PACA, 13354
JEAN PELLETIER, MD, +33 491388204, Jean.PELLETIER@ap-hm.fr
About this study
Official title: Application of the Inhomogeneous Magnetisation Transfer MRI (ihMT) Technique, a New Myelin-specific MRI Technique, in Multiple Sclerosis
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.
Read the 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.
- Conditions
- Sclerosis, Multiple
- Being tested
- inhomogeneous Magnetisation Transfer (ihMT) sequence, inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhomogeneous Magnetisation Transfer (ihMT) sequenceDevice
robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T
inhomogeneous Magnetisation Transfer (ihMT) sequence at 3TDevice
robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T |
What is being measured
The primary outcome is the main question the study is designed to answer.
ihMTR ratio at 1.5TMRI
ihMT 3D technique at 1.5TMRI on active lesions with baseline measurements
Measured: 1 year
Magnetic transfert (MT) at 1.5TMRI
relative signal variations of the conventional magnetization transfer (MT)
Measured: 1 year
Myelin water fraction at 1.5TMRI
myelin water fraction (MWF), an MRI biomarker of myelin, in new MS lesions
Measured: 1 year
Secondary outcomes (2)
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
Measured: 1 year
Evaluate the predictive value of ihMT
Evaluate the predictive value of the measured dynamics with respect to the final progression of the lesions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start14 Jun 2018
- Primary completion14 Aug 2027 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sclerosis, MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600779
- Sponsor's protocol ID
- 2017-61
- Acronym
- ihMTMS
- Status last verified
- Aug 2026
- First submitted
- 6 Jul 2018
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Inhomogeneous Magnetisation Transfer MRI (ihMT) Technique, a New Myelin-specific MRI Technique, in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03600779
- Acronym / sponsor ID
- ihMTMS / 2017-61
- Conditions
- Sclerosis, Multiple
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 14 Aug 2027 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| experimental group 1.5T | Experimental | Device: inhomogeneous Magnetisation Transfer (ihMT) sequencePopulation of patients with myelin syndrome (MS) at the the disease onset with active lesions inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed. |
| control group 1.5 T | Active comparator | Device: inhomogeneous Magnetisation Transfer (ihMT) sequencehealthy volunteers matched in sex and age inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed. |
| experimental group 3T | Experimental | Device: inhomogeneous Magnetisation Transfer (ihMT) sequence at 3TPopulation of patients with myelin syndrome (MS) at the the disease onset with active lesions inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T will be performed. |
| control group 3T | Active comparator | Device: inhomogeneous Magnetisation Transfer (ihMT) sequence at 3Tinhomogeneous Magnetisation Transfer (ihMT) sequence will be performed. inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T will be performed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- For Patients and Controls :
- For patients only :
Key exclusion criteria (9 listed)
- For patients only :
- For Patients and Controls :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhomogeneous Magnetisation Transfer (ihMT) sequencerobust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T | Device | control group 1.5 T, experimental group 1.5T |
| inhomogeneous Magnetisation Transfer (ihMT) sequence at 3Trobust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T | Device | control group 3T, experimental group 3T |
Primary outcome
ihMTR ratio at 1.5TMRI
Time frame: 1 year
ihMT 3D technique at 1.5TMRI on active lesions with baseline measurements
Magnetic transfert (MT) at 1.5TMRI
Time frame: 1 year
relative signal variations of the conventional magnetization transfer (MT)
Myelin water fraction at 1.5TMRI
Time frame: 1 year
myelin water fraction (MWF), an MRI biomarker of myelin, in new MS lesions
2 secondary outcomes
ihMTR ratio at 3TMRI
Time frame: 1 year
Evaluate the predictive value of ihMT
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhomogeneous Magnetisation Transfer (ihMT) sequence and inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T in people with Sclerosis, Multiple, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JEAN PELLETIER, MD (+33 491388204, Jean.PELLETIER@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ihMTR ratio at 1.5TMRI (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.