Phase II Multicenter Clinical Trial of Intraoperative Molecular Imaging with Abenacianine During Lung Cancer Surgery

BACKGROUND: Surgery is the cornerstone for locally contained lung cancer; however, intraoperative challenges include accurate lesion localization and assessment of surgical margins. Intraoperative molecular imaging (IMI) using near-infrared fluorescence-guided surgery is a real-time tumor-targeted optical imaging technique. A multicenter phase II clinical trial evaluated abenacianine (VGT-309), a cathepsin-targeted near-infrared (NIR) IMI agent for visualization of pulmonary nodules and margins during surgery. The primary objective was to assess the efficacy of abenacianine. METHODS: At six sites, 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. RESULTS: Of 89 patients who received abenacianine and surgical resection, 40 (45%) had at least one clinically significant event. Abenacianine with NIR imaging identified lesions not found by standard methods in 33 (37%) patients, synchronous and occult cancers not found by preoperative imaging in three (3%) patients, margins within 10 mm of the closest staple line in eight (9%) patients, and cancerous lymph nodes in one (1%) patient. Abenacianine was safe and well-tolerated in this study; there were no drug-related serious adverse events. CONCLUSIONS: IMI with abenacianine during standard-of-care lung cancer surgery improved intraoperative localization, identification of occult lesions, margin assessment, and lymph node detection, enabling a more complete oncologic resection.