Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 30 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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).
Primary outcome measures
- Correlation of the lesion volume changes to the microglial activity at the initial positron emission tomography imaging [Time frame: Baseline (initial PET), 3, 5, 7 and 10 years]
Secondary outcome measures (2)
- magnetic resonance imaging metrics [Time frame: Baseline (initial PET), 3, 5, 7 and 10 years]
- Multiple Sclerosis Composite Score [Time frame: Baseline (initial positron emission tomography), 3, 5, 7 and 10 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Finland · 1 center
- Turku PET Centre — Turku
Identifiers
NCT: NCT04625049 · FUP-MS