[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
Condition: Carotid Stenosis
MeSH terms: Carotid Stenosis; Constriction, Pathologic
Intervention: [F-18]RDG-K5
Intervention description: Approximately fifteen (15) patients with carotid artery stenosis > 69% will undergo an endarterectomy and will be imaged under PET/CT with [F-18]RGD-K5
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Endarterectomy; K5-C200; RGD-K5; angiogenesis; Carotid CT Angiogram

Summary:

      This trial will be the first trial for the Investigation Product (IP), [F-18]RGD-K5 for
      carotid plaque imaging and will be conducted as a Phase II trial since this compound has
      already been tested in humans for phase I and phase II imaging. All study results will be
      evaluated and analyzed in order to consider the design for future clinical trials.
    

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 >69% luminal diameter as based on
             carotid ultrasound and who is deemed to be a surgical candidate for endarterectomy as
             determined by the vascular surgeon

          -  Participant has had a carotid ultrasound and the report is available for collection

          -  Participant has had or is scheduled to have a carotid CT angiogram for plaque
             localization within 30 days of signing ICF (or else scheduled Carotid CT angiogram)
             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 function 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:

          -  Participant is nursing

          -  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