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
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
Study locations (8)
City of Hope National Medical Center
Duarte, California, 91010
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
University of Colorado Hospital
Aurora, Colorado, 80045
Orlando Health Cancer Center
Orlando, Florida, 32806
University of Michigan
Ann Arbor, Michigan, 48109
Mayo Clinic
Rochester, Minnesota, 55905
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030