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临床试验/NCT02611245
NCT02611245已完成1 期

Phase 1 Study of NIR Fluorescence Guided Thoracic Surgery Using ICG

Chinese Academy of Sciences1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Chongwei Chi, Ph.D

Assistant Professor of Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Chinese Academy of Sciences

研究点 (1)

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