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.
Full Title of Study: “Phase 1 Study of NIR Fluorescence Guided Thoracic Surgery Using ICG”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: October 2016
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.
- Drug: Indocyanine green
- This group of patients accepted intravenous injection from 0.5mg / kg to 5mg / kg ICG within 4 to 24 hours before surgery. All patients under general anesthesia to accept conventional thoracoscopy or thoracotomy. After entering the chest using fluorescence thoracoscopy system to collect the fluorescence and white-light images and record the video. After following the routine preoperative planning surgery, the researchers will carefully assess the possibility of the benign and malignant nodules and to communicate with the families of patients. If the patient’s family expressed their willingness to dissect the nodules, the researchers will remove this extra pulmonary nodules. Resected specimens will send to routine pathological confirmation compared with the fluorescence results.
Arms, Groups and Cohorts
- Experimental: 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.
Clinical Trial Outcome Measures
- Detection rates of lung nodes with fluorescence imaging
- Time Frame: 1 year
- Participants will be followed for the duration of hospital stay, an expected average of 1 year
Participating in This Clinical Trial
- 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 Exclusion Criteria:
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Chinese Academy of Sciences
- Peking University
- Provider of Information About this Clinical Study
- Principal Investigator: Chongwei Chi, Ph.D, Assistant Professor of Key Laboratory of Molecular Imaging, Chinese Academy of Sciences – Chinese Academy of Sciences
- Overall Official(s)
- Jian Zhou, Doctor, Principal Investigator, Peking University People’s Hospital
Chi C, Du Y, Ye J, Kou D, Qiu J, Wang J, Tian J, Chen X. Intraoperative imaging-guided cancer surgery: from current fluorescence molecular imaging methods to future multi-modality imaging technology. Theranostics. 2014 Aug 15;4(11):1072-84. doi: 10.7150/thno.9899. eCollection 2014. Review.
Citations Reporting on Results
Mao Y, Chi C, Yang F, Zhou J, He K, Li H, Chen X, Ye J, Wang J, Tian J. The identification of sub-centimetre nodules by near-infrared fluorescence thoracoscopic systems in pulmonary resection surgeries. Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1190-1196. doi: 10.1093/ejcts/ezx207.
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