Performance Study of SGM-101, a Fluorochrome-labeled Anti-CEA Antibody, for Fluorescence-guided Imaging During Surgical Resection of Pancreatic Cancer After Neoadjuvant Treatment

What this Trial Is About

Pancreatic cancer often has a poor outlook because it is usually diagnosed late, when symptoms appear and the disease has advanced. Surgery offers the only potential cure, but many patients are not eligible for immediate surgery due to tumor involvement with important blood vessels. This trial evaluates the use of a near-infrared fluorescence imaging agent called SGM-101, which targets a tumor marker called Carcino Embryonic Antigen (CEA) often found in pancreatic cancer cells, to help surgeons better visualize tumors and affected lymph nodes during surgery after patients have received preoperative chemotherapy or chemoradiotherapy. Participants receive a single intravenous dose of 10 mg SGM-101 three to five days before their scheduled surgery. The imaging system used is a special near-infrared fluorescence camera that helps surgeons see the fluorescent signal from the tumor and surrounding tissues in real time during the operation. This tool aims to improve the surgeon’s ability to precisely identify and remove the tumor, lymph nodes, and any hidden metastatic tissue. The study includes patients with borderline resectable or locally advanced pancreatic cancer who have undergone neoadjuvant treatment. A separate group of healthy volunteers provides blood samples to support additional research endpoints. During the study, patients will undergo standard surgical resection with additional imaging guidance using the SGM-101 fluorescence signal. Researchers will assess how well the fluorescence imaging helps visualize the tumor and affected areas during surgery. They will also compare the fluorescent signal with the actual tumor status of tissue samples taken during surgery. Safety monitoring, clinical assessments, and follow-ups will be conducted for about three months after surgery. Healthy volunteers contribute a single blood sample without further study activities. Overall, the study seeks to improve surgical outcomes and understanding of tumor spread in pancreatic cancer patients treated with preoperative therapy.

NIR-Fluorescence Guided Surgical Resection of Neoadjuvant Treated Localized Pancreatic Cancer Using SGM-101