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RecruitingLast updated: 16 June 2026

VISUALIZE-2: Testing whether a drug given before surgery can safely help surgeons better identify tumours during surgery using a special imaging technique, in people having surgery for lung cancerA 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

Trial purpose

Medical clipboardCancer treatment; Diagnostic

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

VISUALIZE-2

Clinical summary

Summary

This clinical trial is looking at a new way to help surgeons better find lung cancer during surgery.

The study is testing a drug called abenacianine, which is given by an injection before surgery. This drug is designed to attach to cancer cells and illuminate them when viewed using a special type of imaging called near-infrared (NIR) imaging. This may help surgeons see cancer more clearly and remove it more accurately.

About 132 people with lung cancer who are having surgery will take part in this study. Participants will be randomly allocated (by chance) to one of two treatment groups:

  • Abenacianine + standard surgery: participants receive the drug before their usual surgery.
  • Abenacianine + surgery with NIR imaging: participants receive the drug before undergoing surgery, which is performed using NIR imaging to help guide the procedure.

About 120 participants will be in the group with NIR imaging, and about 12 participants will be in the group without NIR imaging.

The study will look at how safe the drug is and how well it helps identify cancer during surgery.

Conditions

This trial is treating people with lung cancer who are planned to have surgery to remove it

Eligibility

Inclusion

  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

  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

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You are currently being treated on a clinical trial.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Vergent Bioscience, Inc.

Scientific Title

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

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