NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG

Lung Cancer Clinical Trial

Official title:

Phase 1 Study of NIR Fluorescence Guided Thoracic Surgery Using ICG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611245
• Other study ID #: 2011CB707702
• Status: Completed
• Phase: Phase 1
• Start date: August 2015
• Est. completion date: October 2016

Study information

• Verified date: June 2018
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Key Laboratory of Molecular Imaging, Chinese Academy of Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Peking University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rates of lung nodes with fluorescence imaging	Participants will be followed for the duration of hospital stay, an expected average of 1 year	1 year