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TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study (K5-C200)

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ClinicalTrials.gov Identifier: NCT03364270
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Balaji Tamarappoo, Cedars-Sinai Medical Center

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


Condition or disease Intervention/treatment Phase
Carotid Arteries Drug: PET/CT Imaging with [F-18] RGD-K5 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [F-18] RDG-K5
PET/CT Imaging with administration of [F-18] RGD-K5
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
Other Names:
  • RGD-K5
  • K5




Primary Outcome Measures :
  1. Assessment of the uptake of [F-18] RGD-K5 by carotid plaque with PET/MRI imaging [ Time Frame: within 96 hrs of a stroke or TIA (transient ischemic attack) ]
    To assess the uptake of [F-18] RGD-K5 by carotid plaque with PET/MRI imaging in participants prior to carotid endarterectomy and thereby determine if carotid plaque that causes significant stenosis [in participants being considered for carotid endarterectomy (CEA)] is characterized by increased integrin expression and enhanced angiogenesis.


Secondary Outcome Measures :
  1. Collection safety data of [F-18] RGD-K5 in participants with carotid atherosclerosis. [ Time Frame: at the time of imaging and immediately following imaging ]
    to collect safety data of [F-18] RGD-K5 when given with PET/MRI imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364270


Contacts
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Contact: Balaji Tamarappoo, MD 310-423-2219 Balaji.Tamarappoo@cshs.org
Contact: Tracey S Early, BS, MA 310.423.1231 tracey.early@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Tracey S Early, BS, MA    310-423-1231    tracey.early@cshs.org   
Principal Investigator: Balaji K Tamarappoo, MD         
Sponsors and Collaborators
Balaji Tamarappoo
Investigators
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Principal Investigator: Balaji Tamarappoo, MD Cedars-Sinai Medical Center

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Responsible Party: Balaji Tamarappoo, Staff, Cardiac Imaging, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03364270     History of Changes
Other Study ID Numbers: Pro00047624
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Balaji Tamarappoo, Cedars-Sinai Medical Center:
atherosclerosis