Quick Search

 

 


 

 

Home > Protocol Summaries: Compounds > Non-GSK Asset Studies > Protocol Summary for 115241

Protocol Summary for 115241

Protocol Summary
Protocol Id: 115241
Secondary Ids:
Title: A study to characterize the novel TSPO PET radioligand [18F]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis
Phase: phase 2
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Observational
Oversight Authority:
  • United Kingdom : Research Ethics Committee
Collaborators:
Brief 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.
Detailed 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.
Record Verification Date: May 2012
Status: Recruiting
Why Study Stopped:
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Study Completion Date Type: Anticipated
Estimated Primary Completion Date: July 2012
Primary Completion Date Type: Anticipated
Study Design: Case-Control
Time Perspective: Prospective
Biospecimen Retention: None retained
Biospecimen Description:
Primary Outcomes:
  • VT of [18F]PBR111 day 30
Secondary Outcomes:
  • White matter lesion load and distribution 1.5 years
  • Genetic polymorphisms related to the TSPO gene 1.5 years
  • Test-retest variability of regional [18F]PBR111 8 months
  • Cortical grey matter lesion load and distribution 1.5 years
  • regional [18F]PBR111 VT 1.5 years
Conditions:
  • Multiple Sclerosis
Keywords:
Study Population: We expect to be able to achieve the primary objective of the study with 20 subjects in each group (MS patients and healthy volunteers, respectively) (see study size justification below). Up to 24 subjects in each group may be enrolled into the study to ensure we obtain at least ~20 technically adequate PET scans. Data will come from patients with a clinical diagnosis of MS together with age, gender and TSPO binding status matched healthy volunteers.
Sampling Method: Non probability
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 20 Year
Maximum Age: 70 Year
Enrollment: 50
Enrollment Type: Anticipated
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GlaxoSmithKline
Location and Contact Information: Click to view location information