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OpenTrials
Enrolling by Invitation

NCT Number: NCT04625049

Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Turku PET Centre

Turku, Southwest Finland, 20520, Finland

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. 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

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

Secondary outcomes

  1. magnetic resonance imaging metrics

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Acronym: FUP-MS

Important dates

Study start
2021
Primary completion
2030
Study completion
2031
First posted
Nov 12, 2020
Registry last updated
Sep 22, 2025

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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