Actively Recruiting
Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
Led by Vergent Bioscience, Inc. · Updated on 2026-03-30
132
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- 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.
You will not qualify if you...
- Known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine.
- Received chemotherapy, immunotherapy, or radiotherapy within 4 weeks prior to study enrollment.
- Have any co-morbidity or habit that may interfere with compliance or completion of the study.
- Not a candidate for standard of care surgery based on opinion of surgeon, anesthesiologist, or other consulting physician.
- Are prisoners, institutionalized individuals, or unable to consent for themselves.
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Trial Site Locations
Total: 6 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Not Yet Recruiting
2
Orlando Health Cancer Center
Orlando, Florida, United States, 32806
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
4
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
5
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
6
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Not Yet Recruiting
Research Team
B
Brian York
CONTACT
E
Eric Bensen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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