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RecruitingInterventionalPhase 3

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

NCT ID: NCT07499674Sponsor: Vergent Bioscience, Inc.Last updated: 2026-05-29

Summary

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.

Arms & interventions

  • DrugAbenacianine

    Intravenous drug to be given by syringe pump.

  • OtherNear Infrared (NIR) Imaging

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

Outcome measures

Primary

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

    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).

    Time frame: Day of Surgery

Secondary

  • Key Secondary Endpoints

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

  • Key Secondary

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

  • Key Secondary

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

  • Other Secondary Endpoints

    Time frame: Day of surgery

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (8)

City of Hope National Medical Center

Duarte, California, 91010

Recruiting
Jae Kim, MD · Contact

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

Not Yet Recruiting
Daryl Pearlstein, MD · Contact

University of Colorado Hospital

Aurora, Colorado, 80045

Recruiting
Robert Meguid, MD · Contact

Orlando Health Cancer Center

Orlando, Florida, 32806

Recruiting
Luis Herrera, MD · Contact

University of Michigan

Ann Arbor, Michigan, 48109

Recruiting
Rishindra Reddy, MD · Contact

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting
Janani Reisenauer, MD · Contact

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Sunil Singhal, MD · Contact

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
David Rice, M.B., B.CH, B.A.O, F.R.C.S.I · Contact