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Program Number: B058
Session Name: Poster Session

Interim Results from the ILLUMINATE Phase 2 Trial of Pegsitacianine for Detection of Unknown Primary Cancers of the Head and Neck

Natalia M Hajnas, MD; Sindhu Voorugonda, MBBS; Jinming Gao, PhD; Larry Myers, MD; Justin Pyne, MD; Brittny Tillman, MD; Andrew Day, MD, MPH; Lenka Stankova, MD; Zainab Farzal, MD, MPH; John Truelson, MD; Baran Sumer, MD; University of Texas Southwestern Medical Center

Importance: Accurately identifying tumor margins and detecting unknown primary head and neck cancers presents a significant challenge. Enhancing the precision of detection can greatly assist surgeons by enabling more complete tumor resections and can minimize the need for unnecessary tissue resection, ultimately reducing patient morbidity.

Objective: To investigate the safety and tolerability of intravenous pegsitacianine for imaging head and neck cancers, with the aim of improving the identification of unknown primary head and neck cancers.

Design: Phase 2 non-randomized, single-dose, open-label clinical trial (The Illuminate Study).

Setting: Single-center tertiary care institution.

Participants: A total of forty subjects will be enrolled in two parts; Part 1: Subjects with Stage 1 to 4 head and neck squamous cell carcinoma. Part 2: Subjects with Unknown primary head and neck squamous cell carcinoma. After four failed screenings, fifteen patients were dosed and imaged in sixteen separate operations.

Intervention: Pegsitacianine, a pH-sensitive fluorescent nanoparticle designed for tumor targeting, was administered intravenously at a dosage of 1 mg/kg, 6 to 300 hours prior to surgery. Intraoperative imaging was performed using clinical near-infrared cameras.

Main Outcome(s) and Measure(s): Pegsitacianine fluorescence was evaluated using in vivo images taken during surgery and ex vivo images of excised tissues. The surgeon assessed fluorescence presence as a binary outcome (present or absent) for each specimen, with quantification performed using the Cancer Vision Goggles (CVG) system. Imaging results were then correlated with histopathological findings to determine the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for each camera and each surgeon.

Results: Since May 2024, fifteen patients have been enrolled and dosed in the study. There was one serious adverse event (SAE) of post-operative bleeding, which was determined to be unrelated to the study drug. Additionally, there were two Grade 1 adverse events, including a transient elevation in ALT (alanine aminotransferase) and AST (aspartate aminotransferase) values, as well as one infusion reaction characterized by transient flushing that resolved spontaneously.

Fluorescence was detected intraoperatively using five different imaging systems: Spy Phi, Rubina, SP Robot, Xi Robot, and Cancer Vision Goggles (CVG). Among the participants, twelve had oropharyngeal cancers, while three had cancers of the oral cavity. Fourteen patients exhibited areas of fluorescence detected by all of the tested cameras that correlated with histopathologically confirmed cancer.

The image below demonstrates identification of an 8 millimeter second primary tumor using fluorescence.

Conclusions and Relevance:  Fluorescence from pegsitacianine given intravenously can be detected using several clinically approved near-infrared cameras including the Firefly, Standard and Sensitive cameras in the Intuitive Da Vinci Xi and Sp systems.   

Trial Registration:  NCT05576974

 

 

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