RecruitingPhase 3NCT07499674

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


Sponsor

Vergent Bioscience, Inc.

Enrollment

132 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Abenacianine and Near Infrared (NIR) Imaging for people with lung cancer and lung metastases. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbenacianine

Intravenous drug to be given by syringe pump.

OTHERNear Infrared (NIR) Imaging

NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.


Locations(9)

City of Hope National Medical Center

Duarte, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Orlando Health Cancer Center

Orlando, Florida, United States

University of Michigan

Ann Arbor, Michigan, 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

View Full Details on ClinicalTrials.gov

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NCT07499674


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