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

May 28, 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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

Vergent Bioscience, Inc.

Investigators

  • 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)

March 31, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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