Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.
John Waters
Summary
The goal of clinical trial is to test an FDA approved drug called Pafolacianine that attaches to cancer cells and lights up when seen through a special camera system in adults with a suspected primary diagnosis, or a high clinical suspicion of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC/debulking, warranting surgery. The main question it aims to answer is: • Can CYTALUX™ (pafolacianine) injection used with near-infrared (NIR) fluorescent imaging improve the detection of malignant tissue in subjects undergoing surgical resection for cancer? Participants taking part in this study will receive the study medication. Then, during the surgery the investigator team will turn on the camera to evaluate if the tumor is visible with the help of the study medication. Taking part in this study will last about 2 months.
Description
Background and Rationale: Gastroesophageal and pancreatic cancers are aggressive malignancies with limited curative options. Complete surgical resection (R0) remains the cornerstone of curative intent. However, current intraoperative tools-visual inspection, palpation, and endoscopy-are limited in accurately delineating tumor margins and detecting occult lesions. High recurrence rates after surgery suggest a need for improved intraoperative detection techniques. Folate receptor-alpha (FRα) is overexpressed in a variety of epithelial tumors, including gastric and pancreatic cancers. Recent st…