[18F]PBR111 and Microglial Activation in Multiple Sclerosis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Study to Characterize the Novel TSPO PET Radioligand [18F]PBR111 as an in Vivo Marker of Microglial Activation in Multiple Sclerosis|
- VT of [18F]PBR111 [ Time Frame: day 30 ] [ Designated as safety issue: No ]Regional VT of [18F]PBR111 at baseline in MS patients and age- , gender-, and TSPO binding profile- matched healthy controls
- Test-retest variability of regional [18F]PBR111 [ Time Frame: 8 months ] [ Designated as safety issue: No ]Test-retest variability of regional [18F]PBR111 VT in 2 consecutive days in MS patients and age- ,gender-, and TSPO binding profile- matched healthy controls
- regional [18F]PBR111 VT [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]Change in regional [18F]PBR111 VT over ~ 4 months after a baseline assessment in MS patients
- White matter lesion load and distribution [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]White matter lesion load (volume of pathological tissue) and distribution as measured by Gadolinium-enhanced and T2-weighted MRI in MS patients
- Cortical grey matter lesion load and distribution [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]Cortical grey matter lesion load and distribution as estimated by the appropriate MRI technique (including high-field MRI in some cases)
- Genetic polymorphisms related to the TSPO gene [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]Genetic polymorphisms related to the TSPO gene and/or genes encoding other proteins which may modulate the binding of ligands to TSPO or TSPO function
|Study Start Date:||July 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
radioligand to assess binding to TSPO
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428505
|GSK Investigational Site|
|London, United Kingdom, W12 0NN|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|