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

Recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • 18F-PBR06 Drug
    Intervention Desc: Positron Emission Tomography / Computed Tomography (PET-CT) using 18F-PBR06
    ARM 1: Kind: Experimental
    Label: Experimental arm
  • PET-CT Device
    ARM 1: Kind: Experimental
    Label: Experimental arm

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 No
Secondary Levels of leukocyte and T lymphocyte inflammation of the plaque 15 days No
Secondary Plaque parameters composite 15 days No
Primary 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

Sponsors