A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 12
- 主要终点
- Clinically Significant Events (CSE)
研究概览
简要总结
This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female subjects 18 years of age and older
- •Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging
- •Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection
- •Female subjects of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
- •Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
排除标准
- •Previous exposure to OTL38
- •Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
- •History of anaphylactic reactions to folate, including synthetic folic acid (pteroylmonoglutamic acid) and contrast agents containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
- •History of allergy to any of the components of OTL38, including folic acid
- •A positive serum pregnancy test at Screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential
- •Clinically significant abnormalities on electrocardiogram (ECG) at screening.
- •Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule
- •Impaired renal function defined as eGFR< 50 mL/min/1.73m2
- •Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >2x ULN for total bilirubin except in subjects with Gilbert's syndrome.
- •Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug
- •Known sensitivity to fluorescent light
研究组 & 干预措施
Near-Infrared Imaging group
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
干预措施: OTL38 for Injection (Drug)
Near-Infrared Imaging group
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
干预措施: Near infrared camera imaging system (Device)
No Imaging Group
All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.
干预措施: OTL38 for Injection (Drug)
结局指标
主要结局
Clinically Significant Events (CSE)
时间窗: 1 day
The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.
Localization of Primary Nodule
时间窗: 1 day
Proportion of FAS subjects with one or more primary NIR fluorescence positive lung nodules (cancerous or non-cancerous, excluding normal lung parenchyma) not detected under normal light and/or palpation
Identification of Cancerous Synchronous Lesions
时间窗: 1 day
The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation
Positive Resection Margins
时间窗: 1 day
The proportion of FAS subjects with the identification of a cancerous positive margin that fluoresces within (less than or equal to) 10 mm of the surgical resection staple line
次要结局
- Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects(1 day)
- False Positive Rate for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects(1 day)