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

NCT ID: NCT02513589

Last Updated: 2018-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2018-07-04

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental arm

Group Type EXPERIMENTAL

18F-PBR06

Intervention Type DRUG

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

Interventions

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18F-PBR06

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paolo ZANOTTI-FREGONARA

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Paul Perez

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status

Countries

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France

References

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Schollhammer R, Lepreux S, Barthe N, Vimont D, Rullier A, Sibon I, Berard X, Zhang A, Kimura Y, Fujita M, Innis RB, Zanotti-Fregonara P, Morgat C. In vitro and pilot in vivo imaging of 18 kDa translocator protein (TSPO) in inflammatory vascular disease. EJNMMI Res. 2021 May 5;11(1):45. doi: 10.1186/s13550-021-00786-7.

Reference Type DERIVED
PMID: 33950298 (View on PubMed)

Other Identifiers

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CHUBX 2014/17

Identifier Type: -

Identifier Source: org_study_id

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