TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study (K5-C200)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03364270|
Recruitment Status : Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : May 28, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pilot study|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||July 31, 2020|
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
- 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.
- 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
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
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Balaji Tamarappoo, MD||Cedars-Sinai Medical Center|