Phase 1 Study of NIR Fluorescence Guided Thoracic Surgery Using ICG
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Detection rates of lung nodes with fluorescence imaging
研究概览
简要总结
This study aims to first apply near-infrared fluorescence imaging technology in thoracic surgery with indocyanine green in China. To evaluate the feasibility usage of the investigators' fluorescence imaging systems and the safety applications in intraoperative sentinel lymph node mapping of lung and esophageal cancer, lung nodule imaging, lung segment resection boundary determination, esophagus - tubular anastomosis, thoracic duct imaging and chylothorax repairing thoracic surgery. Aim to achieve precise boundaries definition during thoracic surgery and realize accurate, minimally invasive thoracic surgery with fluorescence imaging technology.
详细描述
Lung cancer is a major threat to human health. Diagnosis and treatment using precision medicine is expected to be an effective method for preventing the initiation and progression of cancer. Although anatomical and functional imaging techniques such as radiography, computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) have played an important role for accurate preoperative diagnostics, for the most part these techniques cannot be applied intraoperatively. Optical molecular imaging is a promising technique that provides a high degree of sensitivity and specificity in tumor margin detection. Furthermore, existing clinical applications have proven that optical molecular imaging is a powerful intraoperative tool for guiding surgeons performing precision procedures, thus enabling radical resection and improved survival rates. However, detection depth limitation exists in optical molecular imaging methods and further breakthroughs from optical open surgery to minimally invasive intraoperative imaging methods are needed to develop more extensive and comprehensive intraoperative applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Pulmonary nodules undergoing thoracoscopy or thoracotomy
- •Esophageal cancer patients who underwent radical surgery
- •Preoperative liver function is normal
- •No indocyanine green and iodine allergies, and indocyanine green skin test negative
- •Volunteered to participate in this study and signed informed consent in this study
排除标准
- •Preoperative liver dysfunction
- •Indocyanine green or iodine allergies, or indocyanine green skin test positive
- •Not combined with other well-controlled comorbidities
- •Clinicians considered unsuitable for enrollment
研究组 & 干预措施
Indocyanine green
This group of patients under general anesthesia to accept conventional thoracoscopy or thoracotomy. Before systematic lymphadenectomy, four-point of ICG with 10mg was injected in normal lung tissue around the tumor. After 3-5 minutes, fluorescence and white-light images were collected and recorded in real-time. With the guidance of intraoperative images, all fluorescent lymph nodes were removed and sent to routine pathological confirmation.
干预措施: Indocyanine green (Drug)
结局指标
主要结局
Detection rates of lung nodes with fluorescence imaging
时间窗: 1 year
Participants will be followed for the duration of hospital stay, an expected average of 1 year
次要结局
未报告次要终点
研究者
Chongwei Chi, Ph.D
Assistant Professor of Key Laboratory of Molecular Imaging, Chinese Academy of Sciences
Chinese Academy of Sciences
