Phase 1 Trial of CYTALUX™ (Pafolacianine) Folate Receptor-Targeted Intraoperative Imaging Agent.

This Phase 1 open-label trial by Cedars-Sinai Medical Center is evaluating the feasibility of using CYTALUX™ (pafolacianine), a folate receptor directed fluorescent imaging agent, in adults with gastric, esophageal, and appendiceal adenocarcinoma undergoing planned surgery. Participants receive an intravenous infusion of 0.025 mg/kg CYTALUX™, and imaging is performed using near-infrared technology to delineate margins in real time, aiming to establish optimal imaging parameters for improved surgical outcomes. Surgeons largely still rely on white-light visualization; FR-targeted fluorescence is already used in ovarian and lung surgery, and this extends the approach to GI cancers to reduce positive margins.