Abenacianine: Intravenous drug to be given by syringe pump.
Near Infrared (NIR) Imaging: NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by: — Day of Surgery 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).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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