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

NCT03364270 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00047624
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Uptake of [F-18] RGD-K5 by Carotid Plaque With PET/MRI Imaging in the Artery Believed to be the Cause of Transient Ischemic Attack (TIA) or Stroke Symptoms Compared to the Contralateral Carotid Artery Not Implicated in TIA or Stroke

  To assess the uptake of \[F-18\] RGD-K5 by carotid plaque with PET/MRI imaging in participants prior to carotid enterectomy and thereby determine if carotid plaque that causes TIA or stroke symptoms is characterized by increased integrin expression and enhanced angiogenesis. Each patient serves as their own control. \[F-18\] RGD-K5 (radiotracer) uptake is measured (expressed as target to background ratio) in the carotid artery containing the plaque considered responsible for causing stroke or TIA symptoms (culprit plaque). Plaque maximum standardized uptake value (RT SUVmax) of the radiotracer is compared to tracer maximum standardized uptake value (RT SUVmax) in the contralateral carotid artery which does not contain cluprit plaque.

  within 96 hrs of a stroke or TIA (transient ischemic attack)

Secondary Outcomes (1)

• Number of Participants With Carotid Atherosclerosis

  at the time of imaging and immediately following imaging

Study Arms (1)

[F-18] RDG-K5

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: RGD-K5, K5

[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:

• \. Patients presenting
• a. to the neurologist for evaluation of stroke or TIA (Symptomatic) with: i. Symptomatic patients with plaque ≥70% in at least one carotid artery that would be implicated as the source of embolus responsible for the stroke/TIA. b. or to the vascular surgeon for CEA (Asymptomatic) with: i. asymptomatic patients with a luminal stenosis of ≥70% in at least one carotid artery (stable plaque) referred for CEA ii. age-matched by deciles to symptomatic patients

You may not qualify if:

• stroke due to atrial fibrillation,
• preexisting carotid stents in the artery of interest,
• renal dysfunction defined as glomerular filtration rate (GFR) \<40ml/min,
• allergy to gadolinium based contrast agents,
• Volunteers who have had four or more prior previous gadolinium contrast scans
• metal implants incompatible with MRI or other condition that prohibits MRI,
• pregnancy,
• inability to provide informed consent and
• age ≤18 years.

Sponsors & Collaborators

• Balaji Tamarappoo: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

18F-RGD-K5

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Small sample size Differences in the time between imaging and symptoms of stroke or transient ischemic attack

Results Point of Contact

• Title: Balaji Tamarappoo, MD
• Organization: Cedars-Sinai Medical Center

Balaji.Tamarappoo@cshs.org

3104232219

Study Officials

• Balaji Tamarappoo, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff, Cardiac Imaging

Model Details: Pilot study

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 6, 2017
• Study Start: October 10, 2018
• Primary Completion: February 28, 2020
• Study Completion: May 31, 2020
• Last Updated: August 9, 2022
• Results First Posted: July 20, 2022

Record last verified: 2022-07

Locations

US (1)