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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
Intravenous drug to be given by syringe pump.
NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.
City of Hope National Medical Center
Duarte, California, United States
RECRUITINGHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
NOT_YET_RECRUITINGUniversity of Colorado Hospital
Aurora, Colorado, United States
RECRUITINGOrlando Health Cancer Center
Orlando, Florida, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Texas, MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSt. Vincent's Hospital
Fitzroy, Victoria, Australia
RECRUITINGIdentify 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
Key Secondary Endpoints
To evaluate the Population False Positive Rate for lesions (PFPR-L). A false-positive lesion is defined as tissue that fluoresces and is determined by histopathology to be normal (non-pathological).
Time frame: Upon receipt of histopathology report (~2-3 weeks post surgery)
Key Secondary
To evaluate the Population False Positive Rate for lymph nodes (PFPR-LN). A false-positive lymph node is defined as a resected lymph node that fluoresces and is determined by histopathology to be non-cancerous.
Time frame: Upon receipt of histopathology report. (~2-3 weeks post surgery)
Key Secondary
To evaluate the proportion of participants who have at least one lymph node resected due to fluorescence that would not have been removed under the protocol defined standard of care (SOC) and is confirmed by histopathologic examination to be cancerous.
Time frame: Upon receipt of histopathology report. (~2-3 weeks post surgery)
Other Secondary Endpoints
To evaluate the sensitivity and specificity of abenacianine.
Time frame: Day of surgery
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