Limitations
lung cancer
LUNG CANCER, PRIMARY TUMORS
There are several limitations that need to be addressed in this proof-of-principle study. The sample size in each arm of the study was small, with a total of 9 patients with 14 total lesions undergoing SGM-101–guided resection. Larger clinical phase 2 and 3 randomized controlled studies are needed to discern the benefit of SGM-101 in IMI-guided lung cancer resections. In addition, in this early exploratory cohort, the selection of patients with positive serum CEA levels and/or preoperative biopsy with CEACAM5 immunohistochemical assessment can identify optimal patients who would benefit from SGM-101. Ideal patients who could benefit would be those with lesions greater than 1 cm that are closer to the pleural surface. Although the tracer adds additional cost to surgical care, potential benefits can be derived from SGM-101–guided resections. In optimally selected patients, the NIR tracer can confirm the detection of primary tumors, assess margins, and potentially identify occult lesions that would otherwise be missed by conventional means. These benefits would also facilitate surgery progression in cases of lesion fluorescence because the surgeon would not have to wait for frozen section confirmation, which can take up to 1 hour in certain facilities, therefore decreasing the time the patient is under anesthesia and operating room costs. Additional trials with larger cohorts can address these claims and challenges.