NCT07499674

Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung

A Phase 3, Multi-center, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Abenacianine (VGT-309), a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung - VISUALIZE 2

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Vergent Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multi-center, randomized and intrasubject controlled study to evaluate the safety and efficacy of abenacianine for injection, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer using NIR imaging in participants undergoing surgery for cancer in the lung. Approximately 132 partiipants will be enrolled to ensure a minimum of 115 evaluable participants receiving abenacianine and undergoing NIR imaging and a control group of 12 participants who will receive abenacianine but no NIR imaging.

Conditions

• Lung Cancer
• Lung Metastases

Interventions

Type	Name	Description
DRUG	Abenacianine	Intravenous drug to be given by syringe pump.
OTHER	Near Infrared (NIR) Imaging	NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

6 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study