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Application of ihMT MRI in Multiple Sclerosis (ihMTMS)

Primary Purpose

Sclerosis, Multiple

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
inhomogeneous Magnetisation Transfer (ihMT) sequence
inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sclerosis, Multiple

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • 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:

  • Patients with a progressive form of MS other than the early relapsing-remitting form (primary progressive or secondary progressive)
  • 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

Sites / Locations

  • Assistance Publique Des Hotipaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

experimental group 1.5T

control group 1.5 T

experimental group 3T

control group 3T

Arm Description

Population of patients with myelin syndrome (MS) at the the disease onset with active lesions inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed.

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

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.

inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed. inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T will be performed.

Outcomes

Primary Outcome Measures

ihMTR ratio at 1.5TMRI
ihMT 3D technique at 1.5TMRI on active lesions with baseline measurements
Magnetic transfert (MT) at 1.5TMRI
relative signal variations of the conventional magnetization transfer (MT)
Myelin water fraction at 1.5TMRI
myelin water fraction (MWF), an MRI biomarker of myelin, in new MS lesions

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2018
Last Updated
July 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03600779
Brief Title
Application of ihMT MRI in Multiple Sclerosis
Acronym
ihMTMS
Official Title
Application of the Inhomogeneous Magnetisation Transfer MRI (ihMT) Technique, a New Myelin-specific MRI Technique, in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
June 14, 2024 (Anticipated)
Study Completion Date
June 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sclerosis, Multiple

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group 1.5T
Arm Type
Experimental
Arm Description
Population of patients with myelin syndrome (MS) at the the disease onset with active lesions inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed.
Arm Title
control group 1.5 T
Arm Type
Active Comparator
Arm Description
healthy volunteers matched in sex and age inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed.
Arm Title
experimental group 3T
Arm Type
Experimental
Arm Description
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.
Arm Title
control group 3T
Arm Type
Active Comparator
Arm Description
inhomogeneous Magnetisation Transfer (ihMT) sequence will be performed. inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T will be performed.
Intervention Type
Device
Intervention Name(s)
inhomogeneous Magnetisation Transfer (ihMT) sequence
Intervention Description
robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T
Intervention Type
Device
Intervention Name(s)
inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T
Intervention Description
robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T
Primary Outcome Measure Information:
Title
ihMTR ratio at 1.5TMRI
Description
ihMT 3D technique at 1.5TMRI on active lesions with baseline measurements
Time Frame
1 year
Title
Magnetic transfert (MT) at 1.5TMRI
Description
relative signal variations of the conventional magnetization transfer (MT)
Time Frame
1 year
Title
Myelin water fraction at 1.5TMRI
Description
myelin water fraction (MWF), an MRI biomarker of myelin, in new MS lesions
Time Frame
1 year
Secondary Outcome Measure Information:
Title
ihMTR ratio at 3TMRI
Description
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
Title
Evaluate the predictive value of ihMT
Description
Evaluate the predictive value of the measured dynamics with respect to the final progression of the lesions
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JEAN PELLETIER, MD
Phone
+33 491388204
Email
Jean.PELLETIER@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIE GARRIDO PRADALIE
Organizational Affiliation
APHM
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Des Hotipaux de Marseille
City
Marseille
State/Province
Paca
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JEAN PELLETIER, MD
Phone
+33 491388204
Email
Jean.PELLETIER@ap-hm.fr

12. IPD Sharing Statement

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Application of ihMT MRI in Multiple Sclerosis

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