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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Finland
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20520
      • Turku PET Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the lesion volume changes to the microglial activity at the initial positron emission tomography imaging	Correlation of the lesion volume changes in the magnetic resonance imaging to the microglial activity at the initial PET imaging	Baseline (initial PET), 3, 5, 7 and 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
magnetic resonance imaging metrics	To evaluate whole brain, white matter, gray matter volumes during follow-up	Baseline (initial PET), 3, 5, 7 and 10 years
Multiple Sclerosis Composite Score	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	Baseline (initial positron emission tomography), 3, 5, 7 and 10 years

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Principal Investigator: Laura Airas, Turku University Hospital, division of clinical neurosciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2031

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: FUP-MS

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No