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Completed

NCT Number: NCT02513589

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

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Inflammation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Bordeaux

Bordeaux, 33074, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-PBR06

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. Plaque parameters composite

    Time frame: 15 days

    Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: PLAQINSTEP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2015
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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