Study Stopped
Negativity of the first results of in vivo binding of 18F-PBR06
Molecular Imaging of Inflammation With 18F-PBR06 to Identify Unstable Carotid Plaques in Patients With Stroke
PLAQINSTEP
1 other identifier
interventional
3
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 stroke
Started Sep 2017
Shorter than P25 for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2015
CompletedFirst Posted
Study publicly available on registry
July 31, 2015
CompletedStudy Start
First participant enrolled
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2018
CompletedNovember 23, 2018
November 1, 2018
10 months
July 30, 2015
November 20, 2018
Conditions
Keywords
Outcome Measures
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
15 days
Secondary Outcomes (2)
Levels of leukocyte and T lymphocyte inflammation of the plaque
15 days
Plaque parameters composite
15 days
Study Arms (1)
Experimental arm
EXPERIMENTALInterventions
Positron Emission Tomography / Computed Tomography (PET-CT) using 18F-PBR06
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Bordeaux
Bordeaux, 33074, France
Related Publications (1)
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.
PMID: 33950298DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo ZANOTTI-FREGONARA
University Hospital, Bordeaux
- STUDY CHAIR
Paul Perez
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2015
First Posted
July 31, 2015
Study Start
September 18, 2017
Primary Completion
July 4, 2018
Study Completion
July 4, 2018
Last Updated
November 23, 2018
Record last verified: 2018-11