Sphingosine-1 Phosphate -Receptor Targeting and Microglial Activation (FINGOPET)
Does Targeting of Sphingosine-1 Phosphate Receptors Reduce Microglial Activation in Multiple Sclerosis? A [11C]PK11195 Brain PET Study
Study Overview
Detailed Description
Background and Rationale
In multiple sclerosis (MS), significant pathology correlating to disease progression, to expanded disability status scale (EDSS) and to cognitive decline, takes place outside the plaque areas, i.e. in areas of normal appearing white matter and gray matter. Neuropathological studies suggest that mechanisms involved in this widespread pathology include activation of microglial cells, oxidative stress and deficiency in mitochondrial functions. Activated microglia can be detected in vivo with a translocator protein (TSPO), expressed in activated, but not resting microglia) binding radioligands and positron emission tomography (PET). 11Carbon-PK11195 radioligand is one such radioligand. Importantly, the possible effect of MS therapies on microglial activity can be evaluated in patients in vivo with PET-imaging performed before and after the treatment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Turku, Finland, 20520
- Turku University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Having signed the informed consent of the investigator-initiated PET study
- Age 18 - 58 years at the time of informed consent.
- MS according to Poser or McDonald criteria
- EDSS score from 0.0 to 6.5.
- Moderate to heavy lesion load ( >9 T2 lesions) in MRI
Exclusion Criteria:
- - Patients with other neurodegenerative disease than MS
- Disease modifying therapy (DMT) within 4 weeks of imaging
- Corticosteroid treatment within 4 weeks of imaging
- Patients with significant abnormal findings other than MS in the screening MRI.
- 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)
- Contraindication to PET scan investigations
- Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study.
- Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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MS patients initiating fingolimod
Patients will be imaged using PET and MRI at baseline, and twice during treatment.
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Patients will be imaged using PET and MRI at baseline, and twice during treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of 11C-PK11195-radioligand binding using PET
Time Frame: 0 to 24 weeks
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Patients will be switched to fingolimod from first-line therapies as per indication and as part of their normal treatment regimen, and those who will consent to participate in this investigator-initiated PET study, will be imaged at baseline (pre-treatment phase) and after 6-8 weeks and 24 weeks of treatment.
Purpose is to compare the binding of the radioligand between these three time points.
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0 to 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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MRI metrics
Time Frame: 0, 6-8 wk, 24 wk
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To evaluate the total lesion load of the white matter MS plaques with MRI; baseline vs. 6-8 weeks vs. 24 weeks of Gilenya treatment
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0, 6-8 wk, 24 wk
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura Airas, MD, PhD, Turku University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FINGOPET
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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