UPCC 02526: 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 (VISUALIZE-2)

Study on the Safety and Efficacy of an Investigational Imaging Agent for Lung Cancer Surgery

Enrolling By Invitation
18 years or above
All
Phase 3
132 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lung Cancer, Lung Metastases
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the safety and effectiveness of an investigational imaging agent used during lung cancer surgery. The purpose is to see if this agent can help identify cancerous tissue using near-infrared (NIR) imaging. Participants in this study will undergo surgery for lung cancer, and the investigational agent will be used to highlight cancer cells during the procedure.

Participants will receive an injection of the investigational imaging agent before their surgery. Some participants will also undergo NIR imaging to see how well the agent works in identifying cancer cells. A small control group will receive the agent but will not have NIR imaging. This study aims to enroll around 132 participants to ensure reliable results.

  • Who can participate: Adults aged 18 and older scheduled for lung cancer surgery who meet the surgical requirements are eligible. Participants must agree to use contraception if of childbearing potential and have not been part of another clinical trial in the last 30 days.
  • Study details: Participants will be injected with an investigational imaging agent to help identify cancer during surgery. Some will also undergo NIR imaging to assess the agent's effectiveness.
Updated on 29 May 2026. Study ID: 26-0138
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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