Lung Cancer, Lung Metastases
Conditions
Keywords
Lung Cancer, Metastatic Cancer in Lung
Brief 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.
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.
Sponsors
Vergent Bioscience, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Select Study Staff
Intervention model description
This is a randomized and intrasubject controlled study in which all participants will receive a dose of 0.31mg/kg of abenaniacine 12-96 hours before surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by: | Day of Surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Key Secondary Endpoints | Upon receipt of histopathology report (~2-3 weeks post surgery) | 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). |
| Key Secondary | Upon receipt of histopathology report. (~2-3 weeks post surgery) | 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. |
| Other Secondary Endpoints | Day of surgery | To evaluate the sensitivity and specificity of abenacianine. |
Countries
Australia, United States
Contacts
CONTACTBrian York
CONTACTEric Bensen, PhD
STUDY_DIRECTORCurtis Scribner, MD
Vergent Bio
Outcome results
None listed