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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abenacianine with surgery using Standard of Care (SOC) only | Other | Participants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC only. |
|
| Abenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging | Other | Participants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC plus NIR imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abenacianine | Drug | Intravenous drug to be given by syringe pump. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Upon receipt of histopathology report (~2-3 weeks post surgery) |
| Key Secondary |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Endpoint | Determine the maximum plasma concentration (Cmax) of abenacianine. | Pre-dose through 24 hours post-dose |
| Pharmacokinetic Endpoint | Determine the time to reach the maximum plasma concentration (Tmax) of abenacianine. |
Inclusion Criteria:
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:
Have not participated in an interventional clinical trial within the last 30 days.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian York | Contact | 978-882-1403 | byork@vergentbio.com | |
| Eric Bensen, PhD | Contact | 952-479-7496 | ebensen@vergentbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Curtis Scribner, MD | Vergent Bio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Recruiting | Duarte | California | 91010 | United States |
The joint publication will be coordinated by Vergent. There is no need for individual sites to review specific IPD from other sites.
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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.
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Select Study Staff
| Near Infrared (NIR) Imaging | Other | NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging. |
|
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. |
| 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. | Upon receipt of histopathology report. (~2-3 weeks post surgery) |
| Other Secondary Endpoints | To evaluate the sensitivity and specificity of abenacianine. | Day of surgery |
| Pre-dose through 24 hours post-dase |
| Hoag Memorial Hospital Presbyterian | Not yet recruiting | Newport Beach | California | 92663 | United States |
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| University of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States |
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| Orlando Health Cancer Center | Recruiting | Orlando | Florida | 32806 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Texas, MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| St. Vincent's Hospital | Not yet recruiting | Fitzroy | Victoria | 3065 | Australia |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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