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Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
Sponsor: Vergent Bioscience, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2026-03
Completion Date
2027-03
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Abenacianine
Intravenous drug to be given by syringe pump.
Near Infrared (NIR) Imaging
NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.
Locations (6)
City of Hope National Medical Center
Duarte, California, United States
Orlando Health Cancer Center
Orlando, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
St. Vincent's Hospital
Fitzroy, Victoria, Australia