[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis

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