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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Drug: 18F-PBR06


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br> | Drug: 18F-PBR06<br>* Positron Emission Tomography / Computed Tomography (PET-CT) using 18F-PBR06<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of leukocyte and T lymphocyte inflammation of the plaque | Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap) | 15 days | 
| Plaque parameters composite | Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap) | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron emission tomography, Carotid plaque, Inflammation, Stroke