Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT01428505
Status:
TERMINATED
Last Update Posted:
2016-02-08
First Post:
2011-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
[18F]PBR111 and Microglial Activation in Multiple Sclerosis
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Study to Characterize the Novel TSPO PET Radioligand [18F]PBR111 as an in Vivo Marker of Microglial Activation in Multiple Sclerosis
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Study was terminated because there was insufficient data to complete the study objectives
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: