Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
Sponsored by Vergent Bioscience, Inc.
About this study
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.
Where this study is enrolling
- Call 877-632-6789
University of Texas, MD Anderson Cancer Center
Houston, Texas
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Who can participate
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.
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Trial data sourced from ClinicalTrials.gov.