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

Primary Purpose

Stroke

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
18F-PBR06
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring Positron emission tomography, Carotid plaque, Inflammation, Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

Outcomes

Primary Outcome Measures

Correlation between the value of standardized uptake value (SUV) on PET-CT with 18F-PBR06 and the degree of macrophage infiltration at histological examination

Secondary Outcome Measures

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

Full Information

First Posted
July 30, 2015
Last Updated
November 20, 2018
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02513589
Brief Title
Molecular Imaging of Inflammation With 18F-PBR06 to Identify Unstable Carotid Plaques in Patients With Stroke
Acronym
PLAQINSTEP
Official Title
Molecular Imaging of Inflammation With 18F-PBR06 to Identify Unstable Carotid Plaques in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Negativity of the first results of in vivo binding of 18F-PBR06
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
July 4, 2018 (Actual)
Study Completion Date
July 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Positron emission tomography, Carotid plaque, Inflammation, Stroke

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
18F-PBR06
Intervention Description
Positron Emission Tomography / Computed Tomography (PET-CT) using 18F-PBR06
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Levels of leukocyte and T lymphocyte inflammation of the plaque
Description
Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap)
Time Frame
15 days
Title
Plaque parameters composite
Description
Evaluate the constitutive parameters of the plaque (surface area, thickness, necrotic core and fibrous cap)
Time Frame
15 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo ZANOTTI-FREGONARA
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Perez
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33074
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33950298
Citation
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.
Results Reference
derived

Learn more about this trial

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

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