NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG

Chinese Academy of Sciences

Status and phase: Completed; Phase 1

Conditions: Esophageal Cancer; Lung Cancer

Treatments: Drug: Indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT02611245

2011CB707702

Details and patient eligibility

About

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 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Indocyanine green

Experimental group

Description:

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.

Treatment:

Drug: Indocyanine green