Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung (VISUALIZE-2)

August 17, 2026 updated by: Vergent Bioscience, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
        • Contact:
          • Jae Kim, MD
      • Newport Beach, California, United States, 92663
        • Not yet recruiting
        • Hoag Memorial Hospital Presbyterian
        • Contact:
          • Daryl Pearlstein, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University Of Colorado Hospital
        • Contact:
          • Robert Meguid, MD
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Center
        • Contact:
          • Luis Herrera, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
          • Rishindra Reddy, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Janani Reisenauer, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
          • Sunil Singhal, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas, MD Anderson Cancer Center
        • Contact:
          • David Rice, M.B., B.CH, B.A.O, F.R.C.S.I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Abenacianine with surgery using Standard of Care (SOC) only
Participants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC only.
Drug: Abenacianine
Intravenous drug to be given by syringe pump.
Other: Abenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging
Participants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC plus NIR imaging.
Drug: Abenacianine
Intravenous drug to be given by syringe pump.
Other: Near Infrared (NIR) Imaging
NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Day of Surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Other Secondary Endpoints
Time Frame: Day of surgery
To evaluate the sensitivity and specificity of abenacianine.
Day of surgery
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).
Upon receipt of histopathology report (~2-3 weeks post surgery)
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.
Upon receipt of histopathology report. (~2-3 weeks post surgery)
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.
Upon receipt of histopathology report. (~2-3 weeks post surgery)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Endpoint
Time Frame: Pre-dose through 24 hours post-dose
Determine the maximum plasma concentration (Cmax) of abenacianine.
Pre-dose through 24 hours post-dose
Pharmacokinetic Endpoint
Time Frame: Pre-dose through 24 hours post-dase
Determine the time to reach the maximum plasma concentration (Tmax) of abenacianine.
Pre-dose through 24 hours post-dase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vergent Bioscience, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Curtis Scribner, MD, Vergent Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VGT-309-3-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The joint publication will be coordinated by Vergent. There is no need for individual sites to review specific IPD from other sites.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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