Conditions: Carotid Stenosis
Keywords: Endarterectomy K5-C200 RGD-K5 angiogenesis Carotid CT Angiogram
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: no

Brief 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.

Detailed description:
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).

Arms:
arm 1: \[F-18\]RDG-K5 was administred and PET scan performed

Interventions: intervention 1: [F-18]RDG-K5
Intervention descriptions: intervention 1: 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

Protocol document: