University of Texas Southwestern Medical Center
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent. The main purpose of this study is to investigate whether Pegsitacianine can be used to image head and neck cancers as well as unknown primary cancer of the head and neck 6-300 hours post dose in patients undergoing routine surgery for biopsy, evaluation, detection or removal of their primary cancer. The study consists of two Parts. * Part 1 will be performed in a single dose of 1 mg/kg given such that Pegsitacianine fluorescence can be us…
Inclusion Criteria: 1. Adults ≥18 years of age 2. Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator) 1. Part 1: Stage 1 to 4 HNSCC 2. 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. 3. Acceptable hematologic status (as standard surgery protocol requires, as determined by the Investigator), kidney function and liver function. Elevations of creatinine, alanine aminotransferase, aspart…
Infusion of the Pegsitacianine-Intraoperative fluorescence imaging
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