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

Stroke Clinical Trial

— PLAQINSTEP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02513589
• Other study ID #: CHUBX 2014/17
• Status: Terminated
• Phase: Phase 2
• Start date: September 18, 2017
• Est. completion date: July 4, 2018

Study information

• Verified date: November 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 4, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Stroke

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Levels of leukocyte and T lymphocyte inflammation of the plaque	Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap)	15 days
Secondary	Plaque parameters composite	Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap)	15 days