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[18F]PBR111 and Microglial Activation in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:
A Study to Characterize the Novel TSPO PET Radioligand [18F]PBR111 as an in Vivo Marker of Microglial Activation in Multiple Sclerosis

Clinical Trial Summary

This is a study aimed to characterize [18F]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis. Regional binding of [18F]PBR111 will be quantified with PET in the brain of up to 24 patients with multiple sclerosis and up to 24 age- and gender- matched healthy volunteers.

Clinical Trial Description

Multiple Sclerosis is characterized by brain areas of focal neuroinflammation. Imaging of microglia activation in multiple sclerosis could represent a useful marker of neuroinflammation. A novel PET tracer with high affinity to TSPO, [18F]PBR111, is a promising tool for PET imaging of activated microglia.

This is a study aimed to characterize [18F]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis. Regional binding of [18F]PBR111 will be quantified with PET in the brain of up to 24 patients with multiple sclerosis and up to 24 age- and gender- matched healthy volunteers. A subgroup of patients and healthy volunteers will be scanned twice in consecutive days, to test the reproducibility of the measure. Another subgroup of patients will be re-scanned with [18F]PBR111 after 4-6 months. MRI-based measures will be acquired at baseline and, in those patients with later repeat PET scans, also after 4-6 months.

Data from this study will inform about the possible implementation of the [18F]PBR111 ligand to monitor the neuroinflammatory process, disease progression, and response to treatment in MS patients. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01428505
Study type Interventional
Source GlaxoSmithKline
Contact
Status Terminated
Phase Phase 2
Start date July 2011
Completion date March 2013
View Details
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