Phase 2a Study to Evaluate Safety and Diagnostic Use of Pegsitacianine, an Imaging Agent for Detecting Head and Neck Cancer and Unknown Primary Cancer

What this Trial Is About

Researchers are evaluating Pegsitacianine, an intraoperative fluorescence imaging agent, in patients with head and neck cancers, including unknown primary cancer of the head and neck. This Phase 2a, open-label, non-randomized study aims to assess the safety and diagnostic performance of Pegsitacianine in imaging primary tumors and metastatic lymph nodes during routine surgical procedures. The study has two parts. Part 1 involves giving a single dose of 1 mgkg Pegsitacianine 6 to 300 hours before surgery to patients with head and neck squamous cell carcinoma HNSCC to image their tumors. Part 2 uses the same dosing and timing to image tumors in patients with unknown primary cancer UPC of the head and neck undergoing examination under anesthesia with laryngoscopy and panendoscopy to identify the primary cancer site. If needed, alternate imaging schedules may be used. Participants will receive Pegsitacianine infusion before surgery, and their tumors will be imaged using the fluorescence agent. Researchers will monitor diagnostic performance and safety over five years. Assessments include imaging of primary tumors and metastatic lymph nodes, with additional data collected on HPV status. Follow-up will ensure participant safety and measure imaging effectiveness throughout the study period.

A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)