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NCT Number: NCT07499674

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Metastases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Vincent's Hospital, Fitzroy, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • They have a known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine.
  • 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.
  • They are prisoners, institutionalized individuals, or are unable to consent for themselves.

Treatment and study plan

Abenacianine

Drug

Intravenous drug to be given by syringe pump.

Near Infrared (NIR) Imaging

Other

NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.

Primary outcomes

  1. Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by:

    Time frame: Day of Surgery

    A. Intraoperative localization of one or more preoperatively identified lung lesions using abenacianine with NIR imaging when standard surgical techniques using white light with or without palpation fail to identify the lesion(s).

    B. Identification of one or more synchronous or occult lung lesions using abenacianine with NIR imaging when standard surgical techniques using white light with or without palpation and preoperative imaging fail to identify the lesion(s).

Secondary outcomes

  1. Key Secondary Endpoints

    Time frame: Upon receipt of histopathology report (~2-3 weeks post surgery)

    To evaluate the Population False Positive Rate for lesions (PFPR-L). A false-positive lesion is defined as tissue that fluoresces and is determined by histopathology to be normal (non-pathological).

  2. Key Secondary

    Time frame: Upon receipt of histopathology report. (~2-3 weeks post surgery)

    To evaluate the Population False Positive Rate for lymph nodes (PFPR-LN). A false-positive lymph node is defined as a resected lymph node that fluoresces and is determined by histopathology to be non-cancerous.

  3. Key Secondary

    Time frame: Upon receipt of histopathology report. (~2-3 weeks post surgery)

    To evaluate the proportion of participants who have at least one lymph node resected due to fluorescence that would not have been removed under the protocol defined standard of care (SOC) and is confirmed by histopathologic examination to be cancerous.

  4. Other Secondary Endpoints

    Time frame: Day of surgery

    To evaluate the sensitivity and specificity of abenacianine.

Other outcomes

  1. Pharmacokinetic Endpoint

    Time frame: Pre-dose through 24 hours post-dose

    Determine the maximum plasma concentration (Cmax) of abenacianine.

  2. Pharmacokinetic Endpoint

    Time frame: Pre-dose through 24 hours post-dase

    Determine the time to reach the maximum plasma concentration (Tmax) of abenacianine.

Study contacts

Contact information is provided by the study sponsor or research team.

Brian York

CONTACT

[email protected]

978-882-1403

Eric Bensen, PhD

CONTACT

[email protected]

952-479-7496

Sponsors and collaborators

Lead sponsor

Vergent Bioscience, Inc.

Industry

Registry information

Official study 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

Acronym: VISUALIZE-2

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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