Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Pulmonary Nodule, Solitary
Conditions
Keywords
Pulmonary Nodule Localization, Bronchoscopic Navigation, Fluoroscopic Navigation, Intraoperative Localization, Video-Assisted Thoracoscopic Surgery, VATS, AI-Augmented Navigation, LungVision
Brief summary
This prospective single-center pilot study evaluates the clinical feasibility, localization accuracy, and safety of the LungVision system-an AI-augmented fluoroscopic navigation platform-for real-time intraoperative localization of small pulmonary nodules during video-assisted thoracoscopic surgery (VATS). All enrolled patients underwent dual localization: preoperative marking via CT-guided dye injection or virtual bronchoscopic navigation (Broncus Archimedes), followed by intraoperative localization using the LungVision system. The primary outcome was localization success rate, defined as the proportion of patients achieving fluoroscopic tool-in-lesion confirmation. Secondary outcomes included complete resection rate, navigation time, total operative time, and perioperative complication rate.
Detailed description
Lung cancer is the leading cause of cancer-related mortality worldwide, and accurate intraoperative localization of small pulmonary nodules is critical for guiding thoracoscopic resection. Conventional localization methods, including CT-guided percutaneous dye injection and virtual bronchoscopic navigation, carry limitations such as radiation exposure, pneumothorax risk, and dependence on pre-procedural planning without real-time intraoperative feedback. The LungVision system (Body Vision Medical, Israel) is an AI-augmented fluoroscopic bronchoscopic navigation platform that integrates preoperative CT imaging with real-time C-arm fluoroscopy via machine learning-based image fusion. The system provides continuous intraoperative tool-tip tracking and lesion overlay without additional radiation beyond standard fluoroscopy, enabling real-time navigational feedback during bronchoscopic procedures. This prospective, single-center, single-arm pilot study was conducted at the Department of Thoracic Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. A total of 14 patients with small pulmonary nodules requiring preoperative localization prior to video-assisted thoracoscopic surgery (VATS) were enrolled between January and December 2024. Each patient underwent dual localization: preoperative marking via CT-guided percutaneous dye injection or virtual bronchoscopic navigation (Broncus Archimedes Software System), followed by intraoperative localization using the LungVision system with ICG dye injection under fluoroscopic guidance. The primary outcome was localization success rate, defined as the proportion of patients achieving fluoroscopic tool-in-lesion confirmation using the LungVision system. Secondary outcomes included complete resection rate (confirmed by pathological examination), navigation time, total operative time, and perioperative complication rate assessed up to 30 days postoperatively. Thoracoscopic resection was performed based on the combined localization findings, and all resected specimens were submitted for histopathological analysis. This study was approved by the Institutional Review Board of Tri-Service General Hospital (IRB No.: A202303004) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants prior to enrollment.
Interventions
DEVICELungVision System
The LungVision system is an AI-augmented fluoroscopic bronchoscopic navigation platform developed by Body Vision Medical (Israel). The system integrates preoperative CT imaging with real-time intraoperative C-arm fluoroscopy using machine learning-based image fusion to provide continuous tool-tip tracking and lesion overlay. The system guides the bronchoscopic navigational tool to the target pulmonary nodule without additional radiation beyond standard fluoroscopy. Upon tool-in-lesion confirmation, indocyanine green (ICG) dye is injected transbronchially for surgical marking prior to thoracoscopic resection.
DEVICEPreoperative Dual Localization
As part of the dual-localization protocol, all patients received preoperative localization via one of the following methods prior to LungVision intraoperative navigation: (1) CT-guided percutaneous dye injection using methylene blue, or (2) virtual bronchoscopic navigation using the Broncus Archimedes Software System. The choice of preoperative localization method was determined by the operating surgeon based on nodule characteristics and clinical judgment.
Sponsors
Tri-Service General Hospital (TSGH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All enrolled patients underwent a dual-localization protocol within the same operative session. Preoperative localization was performed using either CT-guided percutaneous dye injection or virtual bronchoscopic navigation (Broncus Archimedes Software System), followed by intraoperative localization using the LungVision system. Each patient served as their own reference, allowing direct intraoperative comparison of localization findings. Thoracoscopic resection was subsequently performed based on the combined localization results.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-65 years * Scheduled to undergo thoracoscopic resection for solitary, subsolid, or ground-glass pulmonary nodules requiring localization * Lesion characteristics and CT imaging indicating need for preoperative localization, as determined by the attending surgeon * Able and willing to complete the study protocol * Able to provide written informed consent
Exclusion criteria
* Age \>65 years * Pregnancy * Bleeding tendency or current use of anticoagulants * Impaired consciousness or inability to communicate * Cognitive impairment precluding autonomous consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Localization Success Rate | Intraoperative | Proportion of patients in whom successful intraoperative pulmonary nodule localization was achieved using the LungVision system, defined as fluoroscopic tool-in-lesion confirmation verified by the operating surgeon based on real-time AI-augmented fluoroscopic overlay. Localization was considered successful when the navigational tool tip was confirmed to be positioned within or immediately adjacent to the target nodule under fluoroscopic guidance prior to dye injection. |
Countries
Taiwan
Outcome results
None listed