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.
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.
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.
Parallel
Abenacianine
DrugIntravenous drug to be given by syringe pump.
Near Infrared (NIR) Imaging
Other interventionNIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.
Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by:
A. Intraoperative localization of one or more preoperatively identified lung lesions using abenacianine with NIR imaging when standard surgical techniques using white light with or without palpation fail to identify the lesion(s). B. Identification of one or more synchronous or occult lung lesions using abenacianine with NIR imaging when standard surgical techniques using white light with or without palpation and preoperative imaging fail to identify the lesion(s).
Key Secondary Endpoints
To evaluate the Population False Positive Rate for lesions (PFPR-L). A false-positive lesion is defined as tissue that fluoresces and is determined by histopathology to be normal (non-pathological).
Key Secondary
To evaluate the Population False Positive Rate for lymph nodes (PFPR-LN). A false-positive lymph node is defined as a resected lymph node that fluoresces and is determined by histopathology to be non-cancerous.
Key Secondary
To evaluate the proportion of participants who have at least one lymph node resected due to fluorescence that would not have been removed under the protocol defined standard of care (SOC) and is confirmed by histopathologic examination to be cancerous.
Other Secondary Endpoints
To evaluate the sensitivity and specificity of abenacianine.
Pharmacokinetic Endpoint
Determine the maximum plasma concentration (Cmax) of abenacianine.
Pharmacokinetic Endpoint
Determine the time to reach the maximum plasma concentration (Tmax) of abenacianine.
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