Intraoperative detection of colorectal and pancreatic liver metastases using SGM-101, a fluorescent antibody targeting CEA.

Background: Fluorescence-guided surgery can provide surgeons with an imaging tool for real-time intraoperative tumor detection. SGM-101, an anti-CEA antibody labelled with a fluorescent dye, is a tumor-specific imaging agent that can aid in improving detection and complete resection for CEA-positive tumors. In this study, the performance of SGM-101 for the detection of colorectal and pancreatic liver metastases was investigated.
Methods: In this open-label, non-randomized, single-arm pilot study, patients were included with liver metastases from colorectal origin and intraoperatively detected liver metastases from pancreatic origin (during planned pancreatic surgery). SGM-101 was administered two to four days before the scheduled surgery as a single intravenous injection. Intraoperative fluorescence imaging was performed using the Quest Spectrum® imaging system. The performance of SGM-101 was assessed by measuring the intraoperative fluorescence signal and comparing this to histopathology.
Results: A total of 19 lesions were found in 11 patients, which were all suspected as malignant in white light and subsequent fluorescence inspection. Seventeen lesions were malignant with a mean tumor-to-background ratio of 1.7. The remaining two lesions were false-positives as proven by histology.
Conclusion: CEA-targeted fluorescence-guided intraoperative tumor detection with SGM-101 is feasible for the detection of colorectal and pancreatic liver metastases.
Competing Interests: Declaration of competing interest The Centre for Human Drug Research (Leiden, Netherlands; a not-for-profit foundation) and the Leiden University Medical Center (Leiden, Netherlands) received financial compensation, study drug and equipment for the execution of this study from Surgimab (Montpellier, France). Framery and Cailler are employed by SurgiMab, which owns the SGM-101 conjugate. Cailler is part of the SurgiMab founders and is stockholder. All other authors declare no competing interests.
(Copyright © 2020. Published by Elsevier Ltd.)