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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02513589

Acronym

PLAQINSTEP

Enrollment

Registered

2015-07-31

Start date

2017-09-18

Completion date

2018-07-04

Last updated

2026-07-23

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

Conditions

Stroke

Keywords

Positron emission tomography, Carotid plaque, Inflammation, Stroke

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).

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.

Interventions

DRUG18F-PBR06

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

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
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

Measure	Time frame	Description
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)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPaolo ZANOTTI-FREGONARA

University Hospital, Bordeaux

STUDY_CHAIRPaul Perez