Clinical trial · Observational
Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Virtual Navigation System | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Historical Controls Cohort
- description
- Lung cancer patients who have previously undergone a clinical bronchoscopy. This group represents the current state-of-the-art bronchoscopy practice.
- label
- Consented Clinical Bronchoscopy Cohort
- description
- Lung cancer patients, scheduled for bronchoscopy, who are consented for bronchoscopy assisted by the Virtual Navigator.
- interventionNames
- Diagnostic Test: Virtual Navigation System
Primary outcomes (5)
- measure
- Safety Measurement
- timeFrame
- 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.
- description
- Presence or absence of adverse events during a procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available