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RECRUITING
NCT07499674
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

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.

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