Remyelination in Multiple Sclerosis: a PET-MR Longitudinal Study Investigating Individual Profiles of Myelin Repair and the Contribution of Neuroinflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-24

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Multiple Sclerosis (MS) is an inflammatory disease where the immune cells invade the central nervous system and destroy an essential element of nerve conduction: the myelin. An interesting feature observed in some patients is a regenerative process, called remyelination, which leads to the production of new myelin. However, the extent of remyelination is very heterogeneous among patients, only a minority of patients show a really efficient repair process along the disease course. In this project, our aim is to explore in vivo the biological mechanisms leading to a successful remyelination in some patients and to a failure in remyelination in others. With this purpose in mind we propose to develop a translational research platform where patients with multiple sclerosis will be investigated in vivo for their potential of remyelination through a follow-up with recently developed imaging technologies using a synergistic combination of magnetic resonance imaging (MRI) and positron emission tomography (PET) to visualize and quantify myelin and neuroinflammation. In parallel blood immune cells from patients will be sampled and profiled to investigate how they could influence remyelination. This part will consist in i) grafting patients' lymphocytes in experimental rodent models of demyelination to characterize how they could promote or inhibit remyelination; ii) performing a functional and multi-omics analysis of peripheral macrophages and analyse relationships with remyelination profiles; iii) profiling T lymphocytes at the single cell level to associate specific subpopulation of the T cells with the remyelination potential assessed in patients with MRI/PET images and in grafted animals.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Neuroinflammation in Multiple Sclerosis by PET-MRI Imaging Using the Radiotracer ([18F]-DPA-714) : a Multicentre Cohort Study (INFLANET)

NCT06280742

Multiple Sclerosis

NOT_YET_RECRUITING NA

Imaging of Intracerebral Inflammation in MS

NCT02305264

Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Primary Progressive

COMPLETED NA

Demyelination and Remyelination in Multiple Sclerosis (MS) Detected by Brain Amyloid PET-CT

NCT05783934

Multiple Sclerosis

COMPLETED NA

PET Study in Multiple Sclerosis

NCT03787446

Multiple Sclerosis

UNKNOWN

Multimodal Imaging Signatures of the Biological Mechanisms Underlying Neurodegeneration in Multiple Sclerosis

NCT05633875

Multiple Sclerosis (MS)

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis Inflammatory Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PET-MRI with [18F]-Florbetaben and PET-MRI with [18F]-DPA-714

PET-MRI with \[18F\]-Florbetaben and PET-MRI with \[18F\]-DPA-714

Group Type OTHER

PET-MRI with [18F]-Florbetaben and PET-MRI with [18F]-DPA-714

Intervention Type PROCEDURE

PET-MRI: 2 at baseline visits (V0 and V1) and 1 at M6

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PET-MRI with [18F]-Florbetaben and PET-MRI with [18F]-DPA-714

PET-MRI: 2 at baseline visits (V0 and V1) and 1 at M6

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

RRMS patients:

1. Age between 18 and 55 years old
2. RRMS according to the 2017 Mc Donald criteria
3. Less than 5 years of disease duration
4. At least 9 supra-tentorial white matter lesions on T2/FLAIR MRI
5. Last treatment with methylprednisolone should have been performed at least 1 month before PET examinations
6. Interferon-beta, glatiramere acetate and oral first line therapy will such as dimethylfumarate or teriflunomide will be admitted
7. Affiliation to a social security scheme or beneficiary of such a scheme (Except "Aide Médicale d'Etat")

Progressive MS patients:

1. Age between 18 and 55 years old
2. Progressive MS (primary or secondary progressive MS) according to the 2017 Mc Donald criteria
3. Less than 10 years of disease duration in the progressive phase
4. At least 9 supra-tentorial white matter lesions on T2/FLAIR MRI
5. Interferon-beta, glatiramere acetate and oral first line therapy will such as dimethylfumarate or teriflunomide will be admitted
6. Affiliation to a social security scheme or beneficiary of such a scheme (except "Aide Médicale d'Etat")

Healthy volunteers:

1. Age between 18 and 55 years old
2. Without any evolutive pathology
3. Able to understand the study objectives and procedures
4. Affiliation to a social security scheme or beneficiary of such a scheme (except "Aide Médicale d'Etat")

Exclusion Criteria

For all participants:

1. Any reasons, which does not allow to perform MRI, including claustrophobia, the implant of a pace maker or the presence of an intra-ocular foreign body (a contra-indication questionnaire will be filled in beforehand)
2. PET for clinical research already done within the last 12 months
3. Low Affinity Binding profile (TSPO polymorphism analyzed at screening visit)
4. Pregnancy, breast-feeding, lack of efficient contraception
5. Current symptoms of severe or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary or cardiac disease, or any other chronic neurological diseases
6. Unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly)
7. Know hypersensitivity to Myelin PET : \[18F\]-Florbetaben
8. Patient under legal protection

1. Treatment with cyclophosphamide, mitoxantrone, fingolimod, cladribine, alemtuzumab, anti CD20 antibodies or natalizumab will not be admitted. These treatments may be administered after the Baseline visit.
2. Known allergy to gadoteric acid
3. Allergies (seafood, pollinosis, urticarial) having required a medical intervention
4. Severe renal insufficiency (creatinine clearance \< 60mL/min).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes