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

NCT05599321 | Completed Results

• 1 other identifier: 20714
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

bronchoscopy; computer-assisted surgery; image-guided surgery; surgical navigation; image-guided biopsy; multimodal imaging

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Tumor Pathology

  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

  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

  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

  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.

Study Arms (2)

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

Interventions

Virtual Navigation System DIAGNOSTIC_TEST

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.

Consented Clinical Bronchoscopy Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Penn State University: lead
• Milton S. Hershey Medical Center: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Because this was a single-site study, the results are not generalizable. The historical controls were not performed concurrently with the live studies. This could result in differences to the clinical environment, such as changes to the guidance systems, during the time periods for the historical controls and live studies. We performed fewer live studies than originally planned, due to a lack of funds. This affects the statistical significance of the overall results.

Results Point of Contact

• Title: William E. Higgins
• Organization: The Pennsylvania State University

weh2@psu.edu

814-865-0186

Study Officials

• William E Higgins, PhD

  Penn State University, University Park, PA 16802

  PRINCIPAL INVESTIGATOR

• Rebecca Bascom, MD

  Penn State Milton S. Hershey Medical Center, Hershey, PA 17033

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 31, 2022
• Study Start: June 16, 2023
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: May 15, 2026
• Results First Posted: May 15, 2026

Record last verified: 2026-05

Locations

US (1)