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Completed

NCT Number: NCT02611245

NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

Beijing, Beijing Municipality, 100190, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ICG

Primary outcomes

  1. Detection rates of lung nodes with fluorescence imaging

    Time frame: 1 year

    Participants will be followed for the duration of hospital stay, an expected average of 1 year

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • Peking University

Registry information

Official study title

Phase 1 Study of NIR Fluorescence Guided Thoracic Surgery Using ICG

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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