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

U

University Hospital of Bordeaux

Status and phase

Terminated
Phase 2

Conditions

Stroke

Treatments

Drug: 18F-PBR06

Study type

Interventional

Funder types

Other

Identifiers

NCT02513589
CHUBX 2014/17

Details and patient eligibility

About

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).

Full 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.

Enrollment

3 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

Experimental arm
Experimental group
Treatment:
Drug: 18F-PBR06

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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