Intraoperative Molecular Imaging of Central Nervous System Tumors Using Same Day Second Window Imaging With Indocyanine Green (TumorGlow™ - CNS)
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- NIR True Positive Rate
研究概览
简要总结
The study is being conducted to determine if a same-day, low-dose intravenous (into a vein) injection of indocyanine green (ICG) (FDA-approved dye) being detected by using an imaging system can be a useful tool in identifying and differentiating tumor tissue from normal tissues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 and older
- •Patients presenting with a nervous system tumor presumed to be resectable and at risk for local recurrence on pre-operative assessment
- •Good operative candidates, as determined by the treating physician and multidisciplinary team
- •Subjects capable of giving informed consent
排除标准
- •Pregnant women, as determined by urinary or serum beta hCG within 48 hours of surgery
- •Subjects with a history of iodide allergies
- •Vulnerable patient populations
- •Patients unable to participate in the consent process
- •Patients with history of uncontrolled HTN (requiring ER admission or ≥ 3 BP medications)
研究组 & 干预措施
SWIG Arm
This is the only arm for the study and will be experimental. All patients will receive the appropriate dosage of the study drug, which will then be used for visualization of the tumor intraoperatively.
干预措施: Administration of Indocyanine Green (ICG) and Visualization of Tumor (Drug)
结局指标
主要结局
NIR True Positive Rate
时间窗: Surgery
Of the additionally resected specimens using NIR, we will find the true positive rate based on pathology. The entire sample will be evaluated jointly; then, each histology will be evaluated separately as there may be multiple specimens per patient surgery. NIR will be considered efficacious if the true positive rate is significantly greater than 50%.
Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)
时间窗: Surgery
SBR analysis will be stratified by histology, and the dosing and timing flowchart will be used to achieve optimal SBR.
NIR Efficiency
时间窗: Surgery
After examining the "equivocal tissue" with white light and NIR imaging, a per person success will be recorded, if least one additional specimen is resected using NIR. NIR will be considered efficacious, if significantly more than 10% of patients meet the success criteria. Each histology will be tested separately.
次要结局
- Positive Predictive Value(Surgery)
- Safety and Toxicity(Surgery)
- Sensitivity(Surgery)
- Specificity(Surgery)
- Association Between Resection Decision and Pathology(Surgery)
- Negative Predictive Value(Surgery)