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RECRUITING Phase 3 ClinicalTrials.gov

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. • ClinicalTrials.gov ID: NCT07499674

Registry updated: 2026-08-19
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Description

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.

Interventions

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

Eligibility criteria

Inclusion Criteria: 1. Be willing and able to sign the informed consent and comply with study procedures. 2. Be at least 18 years of age. 3. Be scheduled for or planning to have a surgical resection of a lung lesion or mass with diagnostic and/or curative intent. 4. Meet all requirements for the planned surgery based on opinion of the surgeon, anesthesiologist, and/or other consulting physician. 5. Be able to meet the following conditions: 1. Female participants must be of non-childbearing potential, or, 2. If of childbearing potential, be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day 30 after treatment. 3. 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. 6. Have not participated in an interventional clinical trial within the last 30 days. Exclusion Criteria: 1. They have a known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine. 2. They have received chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to study enrollment. 3. 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. 4. They are prisoners, institutionalized individuals, or are unable to consent for themselves.

Conditions

Lung Cancer Lung Metastases

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record