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Effect of Cladribine Treatment on Microglial Activation in the CNS

Active Not RecruitingN/A

Sponsor: Turku University Hospital

Conditions: Multiple Sclerosis

Interventions: Imaging

Countries: Finland

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.

Eligibility overview

Sex: ALL

Age: 45 Years to 55 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Turku, Southwest Finland, Finland