NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG

NCT02611245 | Completed Phase 1 DMC

• 1 other identifier: 2011CB707702
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Esophageal Cancer

Keywords

Thoracic Duct; Sentinel lymph node biopsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Indocyanine green

EXPERIMENTAL

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.

Drug: Indocyanine green

Interventions

Indocyanine green 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.

Also known as: ICG

Indocyanine green

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Peking University: collaborator

Study Sites (1)

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Beijing, Beijing Municipality, 100190, China

Location

Related Publications (4)

• 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.

  PMID: 25250092 BACKGROUND

• 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.

  PMID: 28950327 RESULT

• 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.

  PMID: 29049798 DERIVED

• 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.

  PMID: 27499979 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Esophageal Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jian Zhou, Doctor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 20, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

CN (1)