[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
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.
This investigation will be conducted as a Phase II, open-label, single-center, non-randomized
 study. The study is planned to be conducted at one Investigative site in the United States.
 The information collected under this exploratory, Phase II study will not be used for
 diagnostic purposes, to assess the participant's response to therapy, or for clinical
 management of the participant. This will be a pilot prospective cohort study where the
 increased expression of integrin may be seen on the F-18 RGD-K5 PET imaging scans looking at
 carotid plaque in participants with carotid artery stenosis.

 Each completed study participant will undergo one to three visits, including one eligibility
 study visit, the Computed Tomography (CT) angiogram of the carotid visit (if necessary), the
 [F-18] RGD-K5 PET imaging visit, and a 24 hour follow up phone call or visit.

 Procedures: Informed consent (ICF), eligibility blood labs, collection of demographic
 information and medical history, physical examination, vital signs, 12-lead
 Electrocardiograms (ECGs), dosing with [F-18]RGD-K5, PET imaging scan, 24 hour follow up to
 collect adverse events, and plaque immunohistochemical characterization after Carotid
 Endarterectomy (CEA).
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