Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling
- Conditions
- Lung Cancer
- Interventions
- Diagnostic Test: Virtual Navigation System
- Registration Number
- NCT05599321
- Lead Sponsor
- Penn State University
- Brief Summary
The overall goal is to evaluate the role of a Virtual Navigation (VN) system (the Virtual Navigator) in the bronchoscopic evaluation and tissue sampling of lung cancer and other chest lesions at the Penn State Hershey Medical Center (HMC). The Virtual Navigator is a software package that runs on a mobile Windows-based computer. The computer takes in up to four clinical image/video sources, ordered by the clinician for clinical purposes: 1) 3D CT (computed tomography) imaging scan; 2) 3D PET (positron emission tomography) imaging scan (optional); 3) Bronchoscopic video of the airway tree interior; 4) Ultrasound video of scanned anatomy outside the airways, as provided by an endobronchial ultrasound (EBUS) probe (optional). During a live guided procedure, the Virtual Navigator presents images that assist with navigating the bronchoscope to predesignated chest lesions.
Lung cancer patients that present a suspicious peripheral tumor on their chest CT scan are often prescribed to undergo a diagnosis-and-staging bronchoscopy, whereby the bronchoscopist examines both the suspect tumor and any identified central-chest lymph nodes. For the clinical study, we consider bronchoscopy performance for two cohorts: 1) a cohort of consented patients who undergo image-guided bronchoscopy via the Virtual Navigator; and 2) a historical controls cohort consisting of patients who underwent bronchoscopy recently at our medical center (state-of-the-art bronchoscopy practice). The study's general hypothesis is that an image-guided bronchoscopy system (the Virtual Navigator) that integrates 3D imaging, bronchoscopy, and EBUS images enables more complete evaluation and sampling of chest lesions than current state-of-the-art clinical techniques. More specifically, for peripheral-tumor diagnosis, the sub-hypothesis is that the VN system increases diagnostic biopsy yield as compared to state-of-the-art bronchoscopy practice; for central-chest nodal staging, the sub-hypothesis is that the VN system enables the sampling of more lymph nodes than state-of-the-art bronchoscopy practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 166
- patients from age 18 and over
- a planned clinical bronchoscopy to evaluate abnormal lung parenchyma and/or central chest lymph nodes
- a clinical CT scan performed at Hershey Medical Center that meets technical specifications and is available on the Radiology research server
- (Optional, use if available) CT/PET images that meet technical specifications and are available on the Hershey Medical Center clinical image storage system
- inability to give consent
- the CT scan does not meet technical specifications
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Consented Clinical Bronchoscopy Cohort Virtual Navigation System Lung cancer patients, scheduled for bronchoscopy, who are consented for bronchoscopy assisted by the Virtual Navigator.
- Primary Outcome Measures
Name Time Method Safety measurement 1 years Presence or absence of errors in the VN System during bronchoscopic procedure
Functionality measurement 1 years Presence or absence of software malfunctions in the VN System during bronchoscopic procedure
Diagnostic biopsy yield 2 years Comparison of diagnostic biopsy yield between the live cases and historical controls
Number of lymph nodes visited 2 years Comparison of number of lymph nodes visited between the live cases and historical controls
- Secondary Outcome Measures
Name Time Method Biopsy samples 2 years Number of biopsy samples taken per tumor or lymph node
Tumor pathology 2 years Whether a sample is malignant, non-malignant, or indeterminate and adequacy of sample
Procedure complications 2 years Rate of complications from bronchoscopic procedure
Distance from biopsy site to optimal site 2 years Distance between actual biopsy site and computed optimal biopsy site
Procedure time 2 years Procedure time (total and per tumor or lymph node) in minutes
Trial Locations
- Locations (1)
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States