FUP-MS: Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients

Sponsor
Turku University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04625049
Collaborator
(none)
100
1
127
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Study Details

Study Description

Brief Summary

The purpose of this study is to assess whether increased microglial activation (measured using TSPO-PET) at lesion rim is associated with more rapid lesion growth during 10 year follow up.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Objective: To evaluate individual MS lesions and their growth during a total of 10 year follow-up after initial positron emission tomography (PET) -imaging with PK11195 or TMSX radioligands.

    Background: Focal inflammatory lesions in the white and grey matter of the central nervous system represent the best characterized pathological phenomena of MS disease. Some MS lesions slowly expand over time. Neuropathological studies have detected inflammatory rim formed by activated microglia cells around some MS lesions and it has been suggested that the presence of the inflammatory rim could predict lesion expansion. Our hypothesis is that the lesions with higher TSPO or TMSX radioligand binding at the initial PET scan will expand more during the total of 10-year follow up compared to those lesions with lower radioligand binding. This longitudinal follow-up study will provide a more complete picture of the association of the innate immune cell activation, lesion growth and disease progression.

    Study population: The research will recruit approximately 100 MS-patients who have taken part to our previous PET-imaging MS studies in Turku PET centre. The research interventions will consist of magnetic resonance imaging (MRI) scans, blood sampling, clinical neurological evaluation and patient-reported outcome measures (filling forms).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients
    Actual Study Start Date :
    Apr 1, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2030
    Anticipated Study Completion Date :
    Nov 1, 2031

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of the lesion volume changes to the microglial activity at the initial positron emission tomography imaging [Baseline (initial PET), 3, 5, 7 and 10 years]

      Correlation of the lesion volume changes in the magnetic resonance imaging to the microglial activity at the initial PET imaging

    Secondary Outcome Measures

    1. magnetic resonance imaging metrics [Baseline (initial PET), 3, 5, 7 and 10 years]

      To evaluate whole brain, white matter, gray matter volumes during follow-up

    2. Multiple Sclerosis Composite Score [Baseline (initial positron emission tomography), 3, 5, 7 and 10 years]

      Multiple Sclerosis Composite Score which consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score. Lower scores represent greater abnormality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participation to a previous PET imaging study of Airas group

    • MS diagnosis

    Exclusion Criteria:
    • Patients with other neurodegenerative disease than MS

    • Contraindication to MR scan investigations

    • Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Turku PET Centre Turku Finland Proper Finland 20520

    Sponsors and Collaborators

    • Turku University Hospital

    Investigators

    • Principal Investigator: Laura Airas, Turku University Hospital, Division of Clinical Neurosciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Turku University Hospital
    ClinicalTrials.gov Identifier:
    NCT04625049
    Other Study ID Numbers:
    • FUP-MS
    First Posted:
    Nov 12, 2020
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2021