NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG

NCT ID: NCT02611245

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-10-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Indocyanine green

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

ICG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chongwei Chi, Ph.D

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Zhou, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 25250092 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28950327 (View on PubMed)

Yang F, Zhou J, Li H, Yang F, Xiao R, Chi C, Tian J, Wang J. Near-infrared fluorescence-guided thoracoscopic surgical intervention for postoperative chylothorax. Interact Cardiovasc Thorac Surg. 2018 Feb 1;26(2):171-175. doi: 10.1093/icvts/ivx304.

Reference Type: DERIVED

PMID: 29049798 (View on PubMed)

Li H, Zhou J, Chi C, Mao Y, Yang F, Tian J, Wang J. Clinical application of near-infrared thoracoscope with indocyanine green in video-assisted thoracoscopic bullectomy. J Thorac Dis. 2016 Jul;8(7):1841-5. doi: 10.21037/jtd.2016.06.02.

Reference Type: DERIVED

PMID: 27499979 (View on PubMed)

Other Identifiers

2011CB707702

Identifier Type: -

Identifier Source: org_study_id