Molecular Imaging of Inflammation With 18F-PBR06 to Identify Unstable Carotid Plaques in Patients With Stroke

Phase 2

Terminated

• Conditions: Stroke
• Interventions: Drug: 18F-PBR06

• Registration Number: NCT02513589
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Evaluating an innovative molecular imaging technique to visualize inflammation of the atherosclerotic plaque in patients with a recent ischemic stroke (\<15 days) with carotid stenosis\> 50%, by performing a Positron emission tomography-computed tomography (PET-CT) with PBR06 18F, a tracer for Translocator protein (TPSO).

Detailed Description

More than one third of cerebral ischemic events are related to an atheromatous plaque. Inflammation, through a key player, the macrophage, is associated with increased metabolic activity of atherosclerotic plaque and its possible rupture. Inflammation within the plate is thus a marker of instability. These data underscore the importance of a prospective evaluation of inflammation with specific imaging with PET tracers inflammation.

Study Timeline

• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Study Start: 2017-09-18
• Primary Completion: 2018-07-04
• Study Completion: 2018-07-04
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 3

Inclusion Criteria

• Man with transient ischemic attack or recent ischemic stroke (<15j) in the carotid territory, confirmed by MRI
• Man with carotid stenosis> 50% on the side of stroke
• Male candidate for carotid endarterectomy
• Subject affiliated or beneficiary of a social security scheme
• Informed written consent

Exclusion Criteria

• Women
• Chronic inflammatory disease in progress (cancer, vasculitis, ...)
• Patient with infection within 7 days
• A person placed under judicial protection, guardianship
• Incapable of giving consent
• Low affinity binder for TSPO

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	18F-PBR06	-

Primary Outcome Measures

Name	Time	Method
Correlation between the value of standardized uptake value (SUV) on PET-CT with 18F-PBR06 and the degree of macrophage infiltration at histological examination	15 days

Secondary Outcome Measures

Name	Time	Method
Plaque parameters composite	15 days	Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap)
Levels of leukocyte and T lymphocyte inflammation of the plaque	15 days	Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap)

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France