NCT04625049

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
67mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Apr 2021Nov 2031

First Submitted

Initial submission to the registry

November 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2031

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

9.6 years

First QC Date

November 5, 2020

Last Update Submit

September 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • magnetic resonance imaging metrics

    Baseline (initial PET), 3, 5, 7 and 10 years

  • Multiple Sclerosis Composite Score

    Baseline (initial positron emission tomography), 3, 5, 7 and 10 years

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Participation to a previous PET imaging study of Airas group
  • MS diagnosis

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku PET Centre

Turku, Southwest Finland, 20520, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Laura Airas

    Turku University Hospital, Division of Clinical Neurosciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 12, 2020

Study Start

April 1, 2021

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2031

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations