Clinical trial NCT05599321: Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling
Official title: Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: bronchoscopy
computer-assisted surgery
image-guided surgery
surgical navigation
image-guided biopsy
multimodal imaging
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Milton S. Hershey Medical Center
First posted: 2022-10-31
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety measurement
timeFrame: 1 years
measure: Functionality measurement
timeFrame: 1 years
measure: Diagnostic biopsy yield
timeFrame: 2 years
measure: Number of lymph nodes visited
timeFrame: 2 years
Secondary outcomes:
measure: Biopsy samples
timeFrame: 2 years
measure: Tumor pathology
timeFrame: 2 years
measure: Procedure complications
timeFrame: 2 years
measure: Distance from biopsy site to optimal site
timeFrame: 2 years
measure: Procedure time
timeFrame: 2 years
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University, University Park, PA 16802
name: William E Higgins, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State Milton S. Hershey Medical Center, Hershey, PA 17033
name: Rebecca Bascom, MD
role: STUDY_DIRECTOR
References: