Multicenter phase 2 trial of intraoperative molecular imaging with abenacianine during lung cancer surgery

Surgery is the cornerstone for locally contained lung cancer. Intraoperative challenges include accurate lesion localization and assessment of surgical margins. A phase 2 trial at six centers in the USA evaluated abenacianine (VGT-309; a cathepsin-targeted near-infrared intraoperative molecular imaging agent) for visualization of pulmonary nodules and margins during surgery. Patients scheduled to undergo surgery for known or suspected cancer in the lung received intravenous abenacianine 0.32 mg/kg 12-36 h before surgery. Efficacy was measured by the proportion of clinically significant events, defined as localization of lesions not found by standard surgical techniques, identification of additional cancers, identification of inadequate surgical margins confirmed by histology, and detection of cancerous lymph nodes. Of 89 patients who received abenacianine and surgical resection, 40 (45%) had at least one clinically significant event. Identification of lesions not found by standard methods occurred in 33 (37%) patients, synchronous and occult cancers not found by preoperative imaging in three (3%), margins within 10 mm of the closest staple line in eight (9%), and cancerous lymph nodes in one (1%). Abenacianine was safe and well-tolerated, with no drug-related serious adverse events. The authors conclude that use of abenacianine during standard-of-care lung surgery enabled a more complete oncologic resection.