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NCT07499674RecruitingPhase 3

Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung

A Phase 3, Multi-center, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Abenacianine (VGT-309), a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung - VISUALIZE 2

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
132 (estimated)
First submitted
12 Mar 2026
Start date
31 Mar 2026
Primary completion date
Dec 2026
Lead sponsor
Vergent Bioscience, Inc.
Diseases
Lung cancer
NCT number
NCT07499674

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 132
  • From 31 Mar 2026 to the primary completion date, Dec 2026
  • 9 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • They have a known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine.

Other

  • They are prisoners, institutionalized individuals, or are unable to consent for themselves.

Who the study is looking for

  • 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.
  • Be able to meet the following conditions:
    • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Vincent's Hospital
Coordinator of this site? Confirm its status
FitzroyAustraliaRecruiting
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
University of Colorado Hospital
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
City of Hope National Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting
University of Texas - MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Hoag Memorial Hospital Presbyterian
Coordinator of this site? Confirm its status
Newport BeachUnited StatesRecruiting
Orlando Health Cancer Center
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Hospital of the University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.