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NCT Number: NCT03600779

Application of ihMT MRI 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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Des Hotipaux de Marseille

Marseille, PACA, 13354, France

Location status: Recruiting

Location contact

JEAN PELLETIER, MD

CONTACT

[email protected]

+33 491388204

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. ihMTR ratio at 1.5TMRI

    Time frame: 1 year

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

  2. Magnetic transfert (MT) at 1.5TMRI

    Time frame: 1 year

    relative signal variations of the conventional magnetization transfer (MT)

  3. Myelin water fraction at 1.5TMRI

    Time frame: 1 year

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

Secondary outcomes

  1. ihMTR ratio at 3TMRI

    Time frame: 1 year

    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

  2. Evaluate the predictive value of ihMT

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

JEAN PELLETIER, MD

CONTACT

[email protected]

+33 491388204

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: ihMTMS

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
Jul 26, 2018
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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