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

Recruiting now · Phase 3

Conditions studied: Lung Cancer, Lung Metastases

In brief

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.

Key facts

Study ID

NCT07499674

Run by

Vergent Bioscience, Inc.

People needed

132

Starts

2026-03-31

Expected to finish

2027-03-01

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be willing and able to sign the informed consent and comply with study procedures.
• Be at least 18 years of age.
• Be scheduled for or planning to have a surgical resection of a lung lesion or mass with diagnostic and/or curative intent.
• Meet all requirements for the planned surgery based on opinion of the surgeon, anesthesiologist, and/or other consulting physician.
• Be able to meet the following conditions:
• Female participants must be of non-childbearing potential, or,
• If of childbearing potential, be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day 30 after treatment.
• Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days after dosing.
• Have not participated in an interventional clinical trial within the last 30 days.

You may not qualify if…

• They have a known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine.
• They have received chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to study enrollment.
• They have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study. They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.
• They are prisoners, institutionalized individuals, or are unable to consent for themselves.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
• Orlando Health Cancer Center — Orlando, Florida, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• St. Vincent's Hospital — Fitzroy, Victoria, Australia

Full record on ClinicalTrials.gov

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