Clinical trial NCT02611245: NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG
Official title: Phase 1 Study of NIR Fluorescence Guided Thoracic Surgery Using ICG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Esophageal Cancer
Keywords: Thoracic Duct
Sentinel lymph node biopsy
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Peking University
First posted: 2015-11-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Detection rates of lung nodes with fluorescence imaging
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Key Laboratory of Molecular Imaging, Chinese Academy of Sciences
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jian Zhou, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1093/ejcts/ezx207.
citation: 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.
citation: 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.