NCT07499674 Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
| NCT ID | NCT07499674 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vergent Bioscience, Inc. |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 132 participants in total. It began in 2026-03-31 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Curtis Scribner, MD
STUDY DIRECTOR
Vergent Bio
Frequently Asked Questions
Who can join the NCT07499674 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07499674 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 132 participants.
Is NCT07499674 currently recruiting?
Yes, NCT07499674 is actively recruiting participants. Contact the research team at byork@vergentbio.com for enrollment information.
Where is the NCT07499674 trial being conducted?
This trial is being conducted at Duarte, United States, Newport Beach, United States, Aurora, United States, Orlando, United States and 5 additional locations.
Who is sponsoring the NCT07499674 clinical trial?
NCT07499674 is sponsored by Vergent Bioscience, Inc.. The principal investigator is Curtis Scribner, MD at Vergent Bio. The trial plans to enroll 132 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.