TRACER RGD-K5 Carotid Plaque Imaging Study

NCT01968226 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: K5 IND
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Disease; Carotid Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (1)

PET imaging with [F-18] RDG-K5

EXPERIMENTAL

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

Interventions

[F-18] RDG-K5 DRUG

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

Also known as: Radiolabeled tracer

PET imaging with [F-18] RDG-K5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases

Results Point of Contact

• Title: Dr. Balaji Tamarappoo
• Organization: Cleveland Clinic

tamarab@ccf.org

216-444-6765

Study Officials

• Balaji Tamarappoo, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: October 17, 2013
• First Posted: October 23, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 12, 2017
• Results First Posted: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)