Vergent Bioscience, Inc.
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 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…
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.