This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
Adults ≥18 years of age
Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator)
Part 1: Stage 1 to 4 HNSCC
Part 2: UPC squamous cell carcinoma of the head and neck with metastatic disease to at least a single cervical node, AND no biopsy proven evidence of the primary cancer's location.
Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible.
Life expectancy <12 weeks
Karnofsky Performance Status <70%
Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis
University of Texas Southwestern Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator