According to the phase 2b VISUALIZE trial (NCT06145048) published in the Annals of Surgical Oncology, intraoperative molecular imaging with the near-infrared fluorescent agent abenacianine identified at least one clinically significant event in nearly 45% of patients undergoing surgical resection for known or suspected lung cancer. Wright, MBBS, FRACS, PhD, presented findings on how tumor-targeted fluorophores can help surgeons locate small pulmonary lesions during minimally invasive procedures.
Phase 2b VISUALIZE Trial Results and Detection Rates
Intraoperative molecular imaging (IMI) with abenacianine—formerly known as VGT-309—identified at least one clinically significant event (CSE) in 40 of 89 patients, marking a 44.9% rate with a 95% confidence interval ranging from 34.4% to 55.9%, according to the published data. The trial’s lower bound of the confidence interval successfully ruled out the null hypothesis of a CSE rate at or below 10% with a $P$ value under .001. In vivo near-infrared imaging located cancerous lesions with a sensitivity of 0.841 and a positive predictive value of 0.750. Ex vivo imaging performed slightly better, yielding a sensitivity of 0.915. Investigators reported no drug-related serious adverse events across the entire cohort of 89 treated patients.
Addressing Minimally Invasive Lung Cancer Surgery Challenges
Surgeons face a distinct set of hurdles when transitioning from traditional thoracotomy to video-assisted thoracic surgery or robotic thoracic surgery, as noted by Gavin M. Wright, MBBS, FRACS, PhD, director of surgical oncology at St Vincent’s Hospital Melbourne and clinical associate professor at the University of Melbourne. While minimally invasive methods improve long-term patient survival and recovery times, they eliminate the ability for a surgeon to manually feel the lung tissue. Screening programs and incidental CT scans now detect smaller tumors, leaving clinicians in a bind where they must locate and excise tiny nodules without removing excessive healthy lung tissue or leaving malignancy behind.
Pro Tip: Tumor-targeted fluorophores differ from general dyes like indocyanine green by binding specifically to cancer cells and undergoing a chemical reaction before glowing under near-infrared light, adding vital biological data to anatomical CT scans.
Mechanism and Impact of Abenacianine in the Operating Room
Abenacianine functions as a cathepsin-targeted, near-infrared fluorescent imaging agent that illuminates only upon binding to tumor tissue. In the VISUALIZE trial, this targeted glow alerted surgeons to unexpected findings, including hard-to-find tumors, secondary nodules, and lymph node metastasis that had previously tested negative on biopsies. Wright emphasized that these discoveries directly altered patient management in the operating room rather than simply offering a visual display. The agent addresses the risk of missing a tumor sitting just millimeters below the surface during keyhole surgery.
Transition to the Phase 3 VISUALIZE 2 Trial
Building on two earlier single-center phase 2 trials, the positive findings from the initial VISUALIZE study prompted the launch of the ongoing phase 3 VISUALIZE 2 trial (NCT07499674), which began enrolling patients in March 2026. While the phase 2b study evaluated all patients receiving the imaging agent, the phase 3 study introduces a randomized design to directly compare abenacianine against usual care. In this trial, surgeons are restricted from turning on the near-infrared light in one out of every ten patients, establishing a baseline to confirm whether the targeted drug provides a definitive clinical advantage over standard surgical techniques.
Did you know? The ultimate goal for future research with agents like abenacianine is to assess whether a patient’s tumor has been completely, partially, or entirely unaffected by pre-surgical immunotherapy, potentially guiding the extent of surgical resection needed.
Frequently Asked Questions
What is abenacianine?
Abenacianine (formerly VGT-309) is a cathepsin-targeted, near-infrared fluorescent imaging agent designed to bind to cancer cells and glow under specific light frequencies during surgery.
What did the VISUALIZE trial discover?
The trial found that intraoperative molecular imaging with abenacianine identified at least one clinically significant event in 44.9% of patients undergoing lung cancer resections.
Were there safety concerns with abenacianine?
No drug-related serious adverse events were reported among the 89 treated patients in the phase 2b trial.
What is the next step for this research?
Researchers launched the phase 3 VISUALIZE 2 trial in March 2026 to compare surgical outcomes using abenacianine against standard care procedures.
If you found this overview of the VISUALIZE trial insightful, consider subscribing to our newsletter for the latest updates in surgical oncology and clinical trial developments, or leave a comment below to share your perspective on molecular imaging technologies.
Worth a look