Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Virtual Navigation System

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The subject population includes patients whose clinical evaluation requires a diagnostic bronchoscopy for evaluation of parenchymal or mediastinal abnormalities. This patient population is typically 40-70 years old.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• inability to give consent
• the CT scan does not meet technical specifications

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Historical Controls Cohort; Lung cancer patients who have previously undergone a clinical bronchoscopy. This group represents the current state-of-the-art bronchoscopy practice.
Consented Clinical Bronchoscopy Cohort; Lung cancer patients, scheduled for bronchoscopy, who are consented for bronchoscopy assisted by the Virtual Navigator.	Diagnostic test: Virtual Navigation System; The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. The standard OR medical team (technicians, clinical fellows, et al.) is on hand, and standard clinical facilities (e.g., fluoroscopy, CT/PET image viewer) are available. Our technical team is also present to record all procedural video and computer display information. It also operates the guidance computer during the guided procedure and offers any assistance in case of unanticipated issues. The participant's clinical bronchoscopy will be recorded by the radiology imaging management system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Measurement	Presence or absence of adverse events during a procedure	One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.
Functionality Measurement	Presence or absence of software malfunctions in the VN System during bronchoscopic procedure	One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.
Diagnostic Biopsy Yield	Comparison of diagnostic biopsy yield between the historical controls and consented live cases	One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.
Radial Endobronchial Ultrasound (EBUS) Probe Passes	Number of Passes of the Radial Endobronchial Ultrasound (EBUS) Probe per ROI	One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.
Comparison of the Number of Lymph Nodes and Nodal Stations Visited	Comparison of number of lymph nodes and nodal stations visited between the live cases and historical controls	One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Pathology	Whether a sample is malignant, non-malignant, or indeterminate and adequacy of sample	One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.
Procedure Complications	Rate of complications from bronchoscopic procedure	One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.
Distance From Final Selected Site to the Pre-planned Optimal Site	Distance between actual site selected during the live procedure and the pre-planned, computed optimal biopsy site.	One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.
Procedure Time	Procedure time (total and per tumor or lymph node) in minutes	One day. All study related procedures are completed over the course of a day for each participant. There are no follow up visits that occur.

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: William E Higgins, PhD, Penn State University, University Park, PA 16802; Study Director: Rebecca Bascom, MD, Penn State Milton S. Hershey Medical Center, Hershey, PA 17033

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: bronchoscopy; computer-assisted surgery; surgical navigation; multimodal imaging; image-guided surgery; image-guided biopsy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 20714

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No