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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599321
• Other study ID #: 20714
• Status: Recruiting
• Start date: June 16, 2023
• Est. completion date: October 2025

Study information

• Verified date: June 2023
• Source: Penn State University
• Contact: Rebecca Bascom, MD
• Phone: 717-531-2925
• Email: rbascom[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measurement	Presence or absence of errors in the VN System during bronchoscopic procedure	1 years
Primary	Functionality measurement	Presence or absence of software malfunctions in the VN System during bronchoscopic procedure	1 years
Primary	Diagnostic biopsy yield	Comparison of diagnostic biopsy yield between the live cases and historical controls	2 years
Primary	Number of lymph nodes visited	Comparison of number of lymph nodes visited between the live cases and historical controls	2 years
Secondary	Biopsy samples	Number of biopsy samples taken per tumor or lymph node	2 years
Secondary	Tumor pathology	Whether a sample is malignant, non-malignant, or indeterminate and adequacy of sample	2 years
Secondary	Procedure complications	Rate of complications from bronchoscopic procedure	2 years
Secondary	Distance from biopsy site to optimal site	Distance between actual biopsy site and computed optimal biopsy site	2 years
Secondary	Procedure time	Procedure time (total and per tumor or lymph node) in minutes	2 years