TRACER RGD-K5 Carotid Plaque Imaging Study (TRACER)

August 14, 2017 updated by: The Cleveland Clinic

An Exploratory, Phase II, Open Label, Single-Center, Non-Randomized Study Of [F-18] RGD-K5 Positron Emission Tomography (PET) In Participants With Carotid Artery Stenosis

The purpose of this study is to investigate the ability of the compound[F-18]RGD-K5, when used as a tracer during PET (positron emission tomography) imaging, to detect regions of unstable atherosclerotic plaque in the carotid artery of subjects being considered for carotid endarterectomy (CEA),and to confirm this ability through histological studies of samples of carotid artery plaques that will be collected during the planned carotid surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients will be chosen for the study based on presence of carotid artery stenosis ascertained by CTA and carotid artery ultrasound. Patients will receive and intravenous injection of the radiolabeled PET tracer,[F-18]RGD-K5, and will undergo PET imaging of their carotid arteries bilaterally. PET images will be analyzed to determine the standard uptake value (SUV) of [F-18]RGD-K5 uptake by the carotid artery plaque and this will be compared to the SUV of the background (blood pool in the aorta). This will be expressed as a target to background ratio (TBR). Investigators expect to find a significant uptake of [F-18]RGD-K5 by carotid artery palque and investigators therefore expect to find a TBR that is significantly >1. Investigators also expect to find that plaque from patients who show a TBR >1 will also be enriched for histologic markers for inflammation and angiogenesis.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is a female or male of any race/ethnicity >18 years old at the time of the investigational product administration
  • Participant or participant's legally acceptable representative provides written informed consent
  • Participant is capable of complying with study procedures
  • Participant has known carotid artery stenosis of >50% luminal diameter based on carotid ultrasound or computed tomography angiography (CTA), as stated in official clinical report or as measured by PI if no quantitative assessment appears in the report, and who is deemed to be a surgical candidate for endarterectomy
  • Participant has had a carotid ultrasound and/or computed tomography angiography (CTA) and the report is available for collection
  • Participant has had or is scheduled to have a carotid CT angiogram for plaque localization within 60 days of signing ICF (or else scheduled CTA must be performed on a separate day and prior to the investigational PET procedure)
  • Participant has consented to have an endarterectomy
  • Participant will be scheduled for an investigational[F-18]RGD-K5 PET/CT scan within 4 weeks prior to endarterectomy

  • Participant must have renal functions values as defined by laboratory results within the following ranges:

    • Serum creatinine ≤ 1.5 mg/dL
    • Estimated glomerular filtration rate (eGFR): ≥ 45mL/min

Exclusion Criteria:

  • Female participant is nursing
  • Female participant is pregnant
  • Participant has been involved in an investigative, radioactive research procedure within the past 14 days
  • Participant has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
  • Participant has a history or current evidence of any condition, therapy, lab abnormality that, in the opinion of the study investigator or treating physicians might confound the results of the study or poses an additional risk to the participants by their participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET imaging with [F-18] RDG-K5
This is an observational study of a group of individuals who all have carotid artery stenosis. The observation will be the measurement of [F-18]RGD-K5 uptake by the carotid artery plaque after intravenous administration of this radiolabeled tracer using PET imaging.
Drug: [F-18] RDG-K5
Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5
Other Names:
  • Radiolabeled tracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target to Background Ratio (TBR)
Time Frame: Baseline
To assess uptake of [F-18]RGD-K5 by carotid plaque with PET/CT imaging (which will be expressed as a target to background ratio (TBR) of the standard uptake value (SUV)) in participants prior to carotid endarterectomy. The TBR of [F-18]RGD-K5 in the plaque will serve as a surrogate marker of plaque inflammation in participants being considered for carotid endarterectomy.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Balaji Tamarappoo, MD, PhD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 18, 2013

First Posted (Estimate)

October 23, 2013

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K5 IND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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