NCT02611245

NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG

Phase 1 Study of NIR Fluorescence Guided Thoracic Surgery Using ICG

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Chinese Academy of Sciences · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer
• Esophageal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-11-20
• Last updated: 2018-06-08

Locations

1 site across 1 country: China