A multi-center trial will evaluate the safety and efficacy of the investigational imaging agent during minimally invasive and robotic procedures.
Vergent Bioscience announced the initiation of VISUALIZE 2, a Phase 3, multi-center study to evaluate the safety and efficacy of abenacianine (VGT-309) for tumor visualization during lung cancer surgery.
Abenacianine is an investigational intraoperative imaging agent designed to help identify malignant tissue in patients undergoing surgery for suspected or confirmed lung cancer.
Surgery remains a primary treatment approach for many solid tumors, including lung cancer. As minimally invasive and robotic-assisted techniques have become more widely adopted, they can limit a surgeon’s ability to directly see and feel tissue, making tumor localization more challenging.
In prior Phase 2 and Phase 2b lung cancer studies, use of abenacianine contributed to changes in intraoperative decision-making in 43% and 45% of procedures, respectively, according to the company.
The Phase 3 VISUALIZE 2 study is a randomized, open-label, multi-center trial expected to enroll 132 participants across 10 clinical sites in the United States and Australia in 2026. Each participant will receive a single intravenous infusion of abenacianine 12 to 96 hours before surgery.
During the procedure, surgeons will first attempt to localize lesions using standard techniques. Near-infrared imaging with abenacianine will then be used to assess tumor presence, with findings confirmed through histopathologic evaluation.
The primary endpoint is the proportion of patients with at least one clinically significant event, defined as the localization of a lung lesion or identification of additional cancer not detected using standard surgical techniques.
“Once surgery begins, even the most carefully planned procedures can sometimes be limited by what is visible under white light,” says Sunil Singhal, MD, William Maul Measey Professor in surgical research at the University of Pennsylvania Perelman School of Medicine and principal investigator for the study, in a release. “By turning light into molecular insight, abenacianine aims to provide surgeons with actionable, real-time information, and we look forward to confirming if it supports more precise, tissue-sparing decisions.”
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