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Recruiting NCT07499674

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

Phase III Interventional Lung Cancer Lung Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abenacianine, Near Infrared (NIR) Imaging.
Who it may be relevant to
Registry conditions: Lung Cancer, Lung Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by: [Time frame: Day of Surgery]
Secondary outcome measures (4)
  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 8 centers
  • City of Hope National Medical Center — Duarte
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • University of Colorado Hospital — Aurora
  • Orlando Health Cancer Center — Orlando
  • University of Michigan — Ann Arbor
  • Mayo Clinic — Rochester
  • Hospital of the University of Pennsylvania — Philadelphia
  • University of Texas, MD Anderson Cancer Center — Houston
Australia · 1 center
  • St. Vincent's Hospital — Fitzroy

Identifiers

NCT: NCT07499674 · VGT-309-3-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗