Grey matter microglial imaging with [18F]DPA-714 in progressive MS patients

Phase 2

Completed

Conditions: multiple sclerosis
10012303

Registration Number: NL-OMON41799

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 23

Inclusion Criteria

- For the MS patient group: diagnosis primary or secondary progressive MS with EDSS scores 4.0 to 7.5
- 18 to 60 years
- Written informed consent
- No immunomodulating or immunosuppressive treatment in previous three months

Exclusion Criteria

- Inability to undergo MRI, e.g. metal objects in or around the body, claustrophobia or inability to lie still in the scanner. For the MS patients: contra-indication for gadolinium administration, e.g. previous allergic reaction to gadolinium.
- Homozygote Ala(147)Thr genotype (low-affinity binders)
- Significant immune disease other than MS
- (History of) other relevant neurological disease
- History of malignancy
- Known significant cardiac disease
- Inadequate renal function: creatinine clearance <60 ml/min
- Loss or donation of blood over 500 mL within four months prior to screening.
- 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
- Use of benzodiazepines within 1 week of the PET scan

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The aim of this pilot study is to determine whether uptake can be quantified in<br /><br>the cortex and/or hippocampus in vivo to discriminate progressive MS patients<br /><br>from controls</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondarily we will determine whether:<br /><br>1. labeled microglial cells co-localize with MRI detected GML and cortical<br /><br>thinning<br /><br>2. binding in cortex and/or hippocampus correlates with clinical disability and<br /><br>cognitive decline in progressive MS patients<br /><br><br /><br>The main objective of this pilot study is to quantify microglia activation in<br /><br>the cerebral grey matter with [18F]DPA-714 PET. As this pilot study has a limit<br /><br>studypopulation, statistically relevant answers to especially the last<br /><br>objective are not expected. This could be analysed in more detail in a possible<br /><br>larger follow up study to this pilot study.</p><br>