Cancer Clinical Trials
Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung (VISUALIZE-2)
Learn moreWhat is the purpose of this 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
-
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.
- 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.
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
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
- Disease Type/ConditionLung Cancer
- Principal InvestigatorDaryl Pearlstein, MD
- Co-InvestigatorsAlain Mita, MD, Yaser Homsi, MD, Simon Khagi, MD
- Age GroupAdult, Older Adult
- PhaseIII
- ClinicalTrials.gov IDNCT07499674
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Lauren Wagner
lauren.wagner@hoag.org
Hoag Family Cancer Institute
Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.
Stay up-to-date on the latest news from Hoag
By submitting this request, you agree to receive communications from Hoag and accept our Privacy Policy and Terms of Use.