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

May 19, 2026 updated by: University Hospital, Bordeaux
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33074
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of leukocyte and T lymphocyte inflammation of the plaque
Time Frame: 15 days
Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap)
15 days
Plaque parameters composite
Time Frame: 15 days
Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap)
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Paolo ZANOTTI-FREGONARA, University Hospital, Bordeaux
  • Study Chair: Paul Perez, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2017

Primary Completion (Actual)

July 4, 2018

Study Completion (Actual)

July 4, 2018

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimated)

July 31, 2015

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2014/17
  • 2015-003025-34 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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