Imaging activated microglia in relapsing remitting multiple sclerosis: a first in human P2X7r PET study

Completed

Conditions: multiple sclerosis
10012303

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

Inclusion Criteria

- For the MS patient group: diagnosis of relapsing remitting MS with clinically or radiologically active disease
- 20 to 60 years old
- Written informed consent

Exclusion Criteria

- 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>