TRACER RGD-K5 Carotid Plaque Imaging Study
Condition: Carotid Artery Disease; Carotid Stenosis
MeSH terms: Carotid Stenosis; Carotid Artery Diseases; Constriction, Pathologic
Intervention: [F-18] RDG-K5
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
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: carotid artery disease; carotid stenosis; carotid endarterectomy; RDG-K5; PET imaging

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.
    

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