CLADPET
What it found
No result yet.
What was tested
Treatment tested
- Imaging
- Cladribine
DNA inhibitor
What it measured
Main measures
11C-PK11195 binding in MS patient brain
baseline, 18 months
Smouldering inflammationChange in TSPO binding in the NAWM after 18 months of cladribine treatment, measured with distribution volume ratio (DVR) of the 11C-PK11195 radioligand binding
Smouldering inflammationChange in microglial cell activation in different brain areas (NAWM normal appearing grey matter and the chronic active/ smoldering (slowly expanding) lesions) before and after 18 months of treatment with cladribine evaluated with [11C]PK11195-PET-imaging.
MRI lesionsSmouldering inflammation
Other measures (15)
MRI metrics
Baseline, 18 months
MRI lesionsExpanded Disability Status Scale
Baseline, 18 months
Disability progressionMultiple Sclerosis Composite Score
Baseline, 18 months
Thinking and memoryWalking and mobilityArm and hand functionBlood biomarkers
Baseline, 18 months
Blood or spinal fluid markers11C-PK11195 difference in RRMS and historical healthy controls
Baseline, 18 months
Smouldering inflammationQSM-signal in MS patient brain
baseline, 18 months
MRI lesionsSmouldering inflammationChange in TSPO binding in other brain areas of interest after 18 months of cladribine treatment
Smouldering inflammationChange in microglial cell activation in different brain areas (normal appearing white matter (NAWM), normal appearing grey matter (NAGM) and the chronic active/ smoldering lesions) before and after 18 months of treatment with cladribine evaluated with QSM-MRI.
MRI lesionsSmouldering inflammationChange in the total lesion load of the white matter MS plaques at different time points using MRI
MRI lesionsChange in total brain, white matter (WM) and gray matter (GM) volumes using MRI at different time points of the study
MRI lesions
Who could take part
Relapsing MS · 45 to 55
Inclusion Criteria: * Signing the informed consent form * Cladribine treatment is planned and indicated and is according to label * 45-55 years of age at the time of signing the research informed consent form * RRMS diagnosis in accordance with McDonald 2017 criteria Exclusion Criteria: * Patients with other neurodegenerative disease than MS * Abnormal lymphocyte counts * Patients with human immunodeficiency virus (HIV). * Patients with active chronic infection (tuberculosis or hepatitis). * Patients with active malignancy. * Patients with moderate or severe renal impairment (creatinine clearance \<60 mL/min) * Patients that are pregnant or breast-feeding * 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. * Patients with previous alemtuzumab administration * Patients with less than 6 months since previous administration of ocrelizumab or rituximab (or with abnormal B-cell counts) * Patients with less than 1 month since previous administration of other disease modifying therapy
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate the effect of cladribine treatment on microglial activation with conventional MRI, QSM-post processing and TSPO-PET imaging in late stage relapsing remitting multiple sclerosis patients.
Papers
Results
Rajalehto O, Matilainen M, Lehto J, Honkonen E, Koivumaki M, Wahlroos S, Rajander J, Misin O, Luoma A, Laaksonen S, Vuorimaa A, Sucksdorff M, Saraste M, Airas L. Impact of Oral Cladribine on TSPO-PET-Measurable Immune Cell Activation in Multiple Sclerosis. Neurol Ther. 2026 Sep 30. doi: 10.1007/s40120-026-01044-5. Online ahead of print.Results
Sjoros T, Saraste M, Matilainen M, Nylund M, Koivumaki M, Kuhle J, Leppert D, Airas L. Serum glial fibrillary acid protein associates with TSPO-expressing lesions in multiple sclerosis brain. Ther Adv Neurol Disord. 2025 Jul 28;18:17562864251352998. doi: 10.1177/17562864251352998. eCollection 2025.
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History
Started
Jan 2020
Main results due
Feb 2024
Finished
Dec 2025
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