Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma
研究概览
简要总结
Fluorescence-navigated thoracoscopic imaging with indocyanine green (ICG) is a novel technique for detection of small pulmonary nodules other than traditional radiography or intraoperative palpation. As a non-targeted fluorescent contrast agent, ICG accumulates in tumors by the enhanced permeability and retention effect (EPR), making the lesions fluoresce under fluorescent imaging. However, the optimal dosage and injection time of ICG are still under exploration. Hence, we perform this study in humans made up of four groups to determine the optimal time and dose.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peripheral pulmonary solid nodules, with diameter 1-3 cm.
- •Suitable for surgery and signed informed consent.
排除标准
- •Liver dysfunction.
- •Allergic to indocyanine green.
- •Can't tolerate thoracoscopic surgery.
结局指标
主要结局
Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma
时间窗: within 1 week after surgery
We use image analysis software ImageJ to evaluate the strength of luminosity in tumors and normal parenchyma using intraoperative images and calculate signal-to-background-ratios.
次要结局
未报告次要终点
研究者
Jun Wang
Chief，Thoracic Surgery Service
Peking University People's Hospital