Multiple SclerosisFUP-MSNCT04625049
Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 1 Apr 2021to Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Participation to a previous PET imaging study of Airas group
- MS diagnosis
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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).
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (initial PET), 3, 5, 7 and 10 years
Secondary outcomes (2)
magnetic resonance imaging metrics
To evaluate whole brain, white matter, gray matter volumes during follow-up
Measured: 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
Measured: Baseline (initial positron emission tomography), 3, 5, 7 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Apr 2021
- Primary completionNov 2030 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Laura Airas, Principal investigator, Turku University Hospital, Division of Clinical Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625049
- Sponsor's protocol ID
- FUP-MS
- Acronym
- FUP-MS
- Status last verified
- Sep 2025
- First submitted
- 5 Nov 2020
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04625049
- Acronym / sponsor ID
- FUP-MS / FUP-MS
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Participation to a previous PET imaging study of Airas group
- MS diagnosis
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Airas principal investigator
Turku University Hospital, Division of Clinical Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.