Fluorescent abenacianine to help surgeons find lung tumors during surgery
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
Run by Vergent Bioscience, Inc. · NCT07499674 · Data updated 2026-11-12
This tests whether a fluorescent drug called abenacianine helps surgeons see and remove lung cancer or lung metastases during planned lung surgery in adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 132 (estimated) |
| Sponsor | Vergent Bioscience, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 9 sites (Duarte, California and 8 other locations) |
| Status | Recruiting |
| Started | March 31, 2026 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT07499674 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are scheduled for surgical resection of a lung lesion for diagnostic or curative intent and who meet the study's medical and contraception requirements are ideal candidates.
✕Probably not a fit
People not having surgical resection, those who cannot receive the imaging agent or NIR imaging, pregnant or lactating individuals, and those recently in other interventional trials are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3, multicenter, randomized and intrasubject-controlled trial gives participants an intravenous dose of abenacianine, a tumor-targeted activatable fluorescent agent, prior to lung tumor resection. During surgery, near-infrared (NIR) imaging is used to visualize fluorescence and guide identification of cancerous tissue, with a small control group receiving the agent but not NIR imaging. Safety, imaging accuracy, and whether the agent improves detection of tumor tissue are recorded and compared within subjects and across groups. Approximately 132 participants will be enrolled to ensure at least 115 evaluable participants undergo NIR imaging with abenacianine.
Why it matters
Potential benefit: If successful, this could help surgeons detect cancer more precisely during lung operations, potentially reducing missed tumor tissue and improving surgical outcomes.
How similar studies have gone: Early-phase and other tumor-targeted fluorescent imaging studies, including prior investigations of abenacianine, have reported promising tumor-specific fluorescence signals, but large confirmatory Phase 3 evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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City of Hope National Medical Center
Duarte, California, United States Recruiting -
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States Recruiting -
University of Colorado Hospital
Aurora, Colorado, United States Recruiting -
Orlando Health Cancer Center
Orlando, Florida, United States Recruiting -
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Recruiting
Show 3 more locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
St. Vincent's Hospital
Fitzroy, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Brian York
- Email: byork@vergentbio.com
- Phone: 978-882-1403
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.