Pilot study evaluating an innovative molecular imaging technique to visualize inflammation of the atherosclerotic plaque in patients with a recent ischemic stroke by performing a PET-CT with PBR06 18F.

Phase 1

Conditions: stroke
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2015-003025-34-FR

Lead Sponsor: CHU de Bordeaux

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to estimate the correlation between the value of SUV on PET-CT with 18F-PBR06 and the degree of macrophage infiltration at histological examination.;Secondary Objective: - Estimate the ROC curve (sensitivity and specificity) of SUV thresholds that can discriminate the plaques according to their level of inflammation <br>- Assess the degree of leukocyte and T lymphocyte inflammation of the plaque. <br>- Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap) <br>- Compare the value of SUV on PET-CT images of the symptomatic plaque with that of a similar asymptomatic plaque (if available) in the same subject.;Primary end point(s): Estimate the correlation between the value of SUV on PET-CT with 18F-PBR06 and the degree of macrophage infiltration at histological examination.;Timepoint(s) of evaluation of this end point: inclusion visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Estimate sensitivity and specificity of SUV thresholds that can discriminate the plaques according to their level of inflammation <br>- Assess the degree of leukocyte and T lymphocyte inflammation of the plaque. <br>- Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap) <br>- Compare the value of SUV on PET-CT images of the symptomatic plaque with that of a similar asymptomatic plaque (if available) in the same subject.;Timepoint(s) of evaluation of this end point: inclusion visit