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.

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. - PLAQINSTEP

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003025-34-FR

Enrollment

Unknown

Registered

2015-08-06

Start date

2016-12-21

Completion date

Unknown

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

Product Name: (N-2,5-diméthoxybenzyl)-2-[18F]fluoro-N-(2-phénoxyphényl)acétamide) Product Code: 18F-PBR06 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Man with transient ischemic attack or recent ischemic stroke ( 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

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.

Design outcomes

Primary

Measure	Time frame
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 - Assess the degree of leukocyte and T lymphocyte inflammation of the plaque. - Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap) - 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	—

Measure

Time frame

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 - Assess the degree of leukocyte and T lymphocyte inflammation of the plaque. - Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap) - 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

Measure	Time frame
Secondary end point(s): - Estimate sensitivity and specificity of SUV thresholds that can discriminate the plaques according to their level of inflammation - Assess the degree of leukocyte and T lymphocyte inflammation of the plaque. - Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap) - 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	—

Measure

Time frame

Secondary end point(s): - Estimate sensitivity and specificity of SUV thresholds that can discriminate the plaques according to their level of inflammation - Assess the degree of leukocyte and T lymphocyte inflammation of the plaque. - Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap) - 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

—

Countries

France

Contacts

Public ContactREC

CHU de Bordeaux

celine.bairras-martin@chu-bordeaux.fr33557820329

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026