Imaging activated microglia in relapsing remitting multiple sclerosis: a first in human P2X7r PET study
- Conditions
- multiple sclerosis10012303
- Registration Number
- NL-OMON47369
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- For the MS patient group: diagnosis of relapsing remitting MS with clinically or radiologically active disease
- 20 to 60 years old
- Written informed consent
- Current or recent immunomodulating or immunosuppressive therapy, excluding first-line MS treatment started less than 3 months prior to the PET-scans.
- Inability to undergo MRI and PET scan (metal objects in or around the body, claustrophobia or inability to lie still in the scanner) and for the patient group contra-indication for gadolinium administration
- Significant immune disease other than MS
- (History of) other relevant neurological disease
- Known allergy including, but not limited to, hay fever, dust mite allergy and allergies to cats or dogs
- Known asthma
- History of malignancy
- Known significant cardiac disease
- Inadequate renal function: creatinine clearance <60 ml/min
- In male subjects Hb <8.0 g/dL, in female subjects Hb <7.0 g/dL
- Pregnant or breast feeding
- (History of) alcohol and/or drug abuse
- Exposure to previous radiation leading to annual cumulative dose of more than 10 mSV if participating in this protocol
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To determine whether binding of the P2X7-receptor radioligand [11C]SMW139 in<br /><br>the brain in vivo can discriminate active RRMS patients from healthy controls.<br /><br>- To assess retest variability in regional [11C]SMW139 brain uptake<br /><br>- To evaluate which tracer kinetic method is the most suitable for<br /><br>quantification of [11C]SMW139 binding.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To determine whether [11C]SMW139 binding is increased in T2 hyperintense<br /><br>lesions and T1 gadolinium enhancing on MRI.<br /><br>- To determine whether [11C]SMW139 binding correlates with clinical disability<br /><br>in clinically and/or radiologically active RRMS patients.</p><br>