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NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG

Phase 1 Study of NIR Fluorescence Guided Thoracic Surgery Using ICG

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02611245
Enrollment
36
Registered
2015-11-20
Start date
2015-08-31
Completion date
2016-10-31
Last updated
2018-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Lung Cancer

Keywords

Thoracic Duct, Sentinel lymph node biopsy

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.

Interventions

DRUGIndocyanine 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.

Sponsors

Peking University
CollaboratorOTHER
Chinese Academy of Sciences
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detection rates of lung nodes with fluorescence imaging1 yearParticipants will be followed for the duration of hospital stay, an expected average of 1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026