Tests abenacianine imaging to help find lung cancer during surgery
Tests a fluorescent imaging agent to help identify lung cancer during surgery.
Plain-language title generated from the registry record
Registry title: Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
Key facts
- Where
- Fitzroy, AustraliaSee the site
- Phase
- Phase 3
Where in Australia
- St. Vincent's HospitalFitzroy, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vergent Bioscience, Inc.
- Trial code
- NCT07499674
- Record updated
- 2 November 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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 have a known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine; They are prisoners, institutionalized individuals, or are unable to consent for themselves.