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TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study

NCT03364270 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-08-09

Study results available
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Summary

The purpose of this study is to investigate the ability of a new investigational agent compound \[F-18\] labeled RGD-K5 to detect unstable atherosclerotic plaque in the carotid artery of subjects being considered for carotid endarterectomy (CEA), and to confirm this ability through tissue analysis of samples of carotid artery plaques that will be collected during the planned carotid surgery. \[F-18\] RGD-K5 is a radioactive tracer used in imaging to detect active growth of new blood vessels and presence of macrophages. Patients with unstable plaque may be prone to rupture of the plaque due to increase in macrophage activity and growth of new blood vessels. \[F-18\] RGD-K5 is an investigational agent, which means that it has not yet been approved by the US Food and Drug Administration (FDA).

Unstable atherosclerotic plaque that is prone to rupture is characterized by an increase in the number of macrophages and enhanced angiogenesis. Both neovascular endothelium and macrophages exhibit increased Alpha-v beta3 integrin expression. PET (Positron Emission Tomography) imaging of \[F-18\] RGD-K5 uptake may identify carotid plaque with increased inflammation and neovascularization and may therefore detect unstable plaque in participants with carotid artery stenosis.

Prior to Dr. Tamarappoo's relocation to Cedars Sinai Medical Center (CSMC), 5 subjects were enrolled at the Cleveland Clinic where PET-CT (Positron Emission Tomography - Computed Tomography) was performed. 6 subjects will be scanned at Cedars using PET-MRI (Positron emission tomography-magnetic resonance imaging). Based on preliminary data with PET-CTA, the investigator strongly believes the study will be able to reproducibly detect significant \[F-18\] RGD-K5 uptake in plaque from symptomatic patients. Ultimately, demonstrating preferential \[F-18\] RGD-K5 uptake in symptomatic patients will significantly impact the way in which patients with carotid plaque (at risk for stroke) are treated and it may prevent unnecessary surgical and endovascular procedures in this population

Conditions

  • Carotid Arteries

Interventions

DRUG

PET/CT Imaging with [F-18] RGD-K5

PET Imaging/scan with \[F-18\] RGD-K5, PET Imaging/scan with RGD-K5, PET Imaging/scan with K5

Sponsors & Collaborators

  • Balaji Tamarappoo

    lead OTHER

Principal Investigators

  • Balaji Tamarappoo, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2020-02-28
Completion
2020-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03364270 on ClinicalTrials.gov