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TRACER RGD-K5 Carotid Plaque Imaging Study (TRACER)

Primary Purpose

Carotid Artery Disease, Carotid Stenosis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

[F-18] RDG-K5

About this trial

This is an interventional diagnostic trial for Carotid Artery Disease focused on measuring carotid artery disease, carotid stenosis, carotid endarterectomy, RDG-K5, PET imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET imaging with [F-18] RDG-K5

Arm Description

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.

Outcomes

Primary Outcome Measures

Target to Background Ratio (TBR)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01968226

First Posted

October 17, 2013

Last Updated

August 14, 2017

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01968226

Brief Title

TRACER RGD-K5 Carotid Plaque Imaging Study

Acronym

TRACER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Why Stopped

Investigator left instititution

Study Start Date

November 2013 (Actual)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Artery Disease, Carotid Stenosis

Keywords

carotid artery disease, carotid stenosis, carotid endarterectomy, RDG-K5, PET imaging

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

PET imaging with [F-18] RDG-K5

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

[F-18] RDG-K5

Other Intervention Name(s)

Radiolabeled tracer

Intervention Description

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

Primary Outcome Measure Information:

Title

Target to Background Ratio (TBR)

Description

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Balaji Tamarappoo, MD, PhD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

TRACER RGD-K5 Carotid Plaque Imaging Study

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