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
Vergent Bioscience, Inc.
132 participants
Mar 1, 2026
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
Inclusion Criteria9
- 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.
Exclusion Criteria4
- 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.
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Interventions
Intravenous drug to be given by syringe pump.
NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07499674