A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)
研究概览
简要总结
This is a Phase 1/2 study in patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment who are considered to be good surgical candidates to evaluate the safety and efficacy of the image-guided surgery using indocyanine green for intramolecular imaging of solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adult patients 18 years of age or older.
- •Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment.
- •Good operative candidate as determined by the treating physician and/or multidisciplinary team.
- •Subject capable of giving informed consent.
排除标准
- •Subject unable to participate in the consent process.
- •Vulnerable population including pregnant women, prisoners, and children.
- •History of uncontrolled hypertension (e.g., history of an ER admission for hypertensive crisis or ≥ 3 blood pressure medications)
- •Patients with a self-reported history of iodide allergies.
研究组 & 干预措施
Cohort 1
Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has not been fully studied will be enrolled: glioma, breast cancer, colon cancer, rectal cancer, head and neck cancer, pulmonary metastasectomy (colorectal mets), thymoma, ovarian cancer, prostate cancer, renal cell carcinoma, thyroid cancer, parathyroid adenoma, mesothelioma, esophageal cancer, pancreas cancer, stomach cancer.
干预措施: Indocyanine Green (Drug)
Cohort 2
Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has been fully studied will be enrolled: non-small cell lung cancer, metastatic sarcoma to the lung, brain meningioma.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)
时间窗: Up to 5 days
Timing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.
Cohort 1: Determine the safety of indocyanine green (all tumor types combined)
时间窗: Up to 5 days
Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).
Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific)
时间窗: Up to 5 days
Dosing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.
Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific)
时间窗: Up to 5 days
Nodule/lesion-level and subject-level sensitivity and specificity of TumorGlow (tumor type-specific). * Sensitivity of indocyanine green = TP/(TP+FN) = (# that fluoresce and are cancer)/(# that are cancer) * Specificity of indocyanine green = TN/(TN+FP) = (# that not cancer and do not fluoresce)/(# that are not cancer)
Cohort 2: Confirm the efficacy of indocyanine green used with Near Infrared (NIR) fluorescent imaging as measured by Clinically Significant Event (CSE) rate (tumor type-specific)
时间窗: Up to 5 days
Clinically Significant Event (CSE) rate (tumor type-specific). A CSE includes any of the following event: * One or more primary nodule (cancerous or non-cancerous) not detected under normal light and/or palpation but is detected by imaging, * One or more cancerous synchronous lesion not detected under normal light and/or palpation but is detected by imaging, * The identification of a cancer positive margin that fluoresces within (less than or equal to) 5 mm of the surgical margin.
次要结局
- Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific)(Up to 5 days)
- Cohort 1: Provide preliminary estimate of the efficacy of indocyanine green for locating additional cancers and missed surgical margins as measured by CSE rate (tumor type-specific)(Up to 5 days)
- Cohort 2: Confirm the safety of indocyanine green (all tumor types combined)(Up to 5 days)