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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Terminated

CT.gov ID

NCT02513589

Collaborator

(none)

Enrollment

Location

Arm

9.5

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: 18F-PBR06	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 18, 2017

Actual Primary Completion Date :

Jul 4, 2018

Actual Study Completion Date :

Jul 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental arm	Drug: 18F-PBR06 Positron Emission Tomography / Computed Tomography (PET-CT) using 18F-PBR06

Arm

Intervention/Treatment

Experimental: Experimental arm

Drug: 18F-PBR06

Positron Emission Tomography / Computed Tomography (PET-CT) using 18F-PBR06

Outcome Measures

Primary Outcome Measures

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

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)
Plaque parameters composite [15 days]
Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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