Accurate Planning and Guidance of Bronchoscopy for Lung Cancer Management

The main objective of this project is to demonstrate the potential of three new technical innovations for improving state-of-the-art bronchoscopy guidance systems.

Through this study, we plan to generate preliminary data that demonstrates the potential of three new innovations for enhancing existing bronchoscopy systems in the live clinical setting.

The goal is to demonstrate the potential of the new innovations: 1. to demonstrate the potential of a new methodology to reduce errors from CT-to-body divergence in the live clinical setting, 2. to demonstrate the potential of the new methodologies to enable live rerouting of a guided bronchoscopy, and 3. to perform automatic real-time mucosal lesion detection during a standard airway examination.

These innovations could potentially improve current image-guided bronchoscopy systems and be used for future robotic bronchoscopy.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer (Diagnosis)
• Intervention / Treatment: Diagnostic test: Virtual Navigation System

• Study Type: Observational
• Enrollment (Estimated): 6

Contacts and Locations

• Study Contact: Name: William E Higgins, PhD; Phone Number: 814-865-0186; Email: weh2@psu.edu
• Study Contact Backup: Name: Rebecca Bascom, MD, MPH; Phone Number: 717-531-2925; Email: rbascom@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
      • Contact: Timothy P Sheehan, MS; Phone Number: 284024 717-531-0003; Email: tsheehan@pennstatehealth.psu.edu
      • Sub-Investigator: Rebecca Bascom, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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:

1. a planned clinical bronchoscopy to evaluate abnormal lung parenchyma and/or central chest lymph nodes;

2. Radiology images, previously obtained for clinical purposes, that meet technical specifications and are available on our team's Radiology research server or can be uploaded from the Hershey Medical Center clinical image storage system.

   1. a clinical CT scan performed at Hershey Medical Center, AND
   2. Either one of two additional clinically available scans:
   1. CT/PET study OR
   2. a clinical CT scan that includes inspiratory and expiratory images
3. Must be able to read, write, and speak English.

Exclusion Criteria:

1. Special classes of subjects that will be excluded are pregnant women because clinical CT scans and CT/PET studies are avoided because of the potential for radiation injury to the fetus.
2. Mentally incompetent subjects will be excluded. They will be identified as such because their treating clinician will have deemed them unable to provide consent for their clinical procedure. The clinical record will indicate whether the patient is providing consent or a surrogate decision-maker has been needed. Patients with a surrogate decision-maker will be excluded.
3. We will exclude prisoners and institutionalized individuals because their autonomy is compromised by their status, and the study provides no direct benefit from which they would be excluded. Individuals who become prisoners or are institutionalized after giving consent but before their diagnostic procedure would also be excluded. Their clinical record will identify if they are in custody.
4. Children are not part of this project because they do not get lung cancer. Therefore, we do not provide processes for meeting requirements for parental permission and child assent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Consented Clinical Bronchoscopy Cohort; Lung cancer patients, scheduled for bronchoscopy, who are consented for bronchoscopy 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 video feed. 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
Functionality of CTBD Compensation	Establish the functionality of the CTBD compensation methodology during a live guided bronchoscopy to a preselected ROI.	15 minutes
Procedure time of CTBD Compensation	Total live procedure time taken to complete bronchoscope navigation to the ROI.	15 minutes
Functionality of Rerouting Methodology	Functionality of the rerouting methodology during a live guided bronchoscopy to a preselected ROI for the situation that an airway branch along the preplanned airway route to the ROI is unnavigable.	15 minutes
Procedure time of Rerouting Methodology	Total live procedure time taken to complete bronchoscope navigation to the ROI, including rerouting.	15 minutes
Functionality of Rerouting to a new ROI	Functionality of the rerouting methodology during a live guided bronchoscopy to a preselected ROI for the situation where the system is rerouted to a new ROI during navigation.	15 minutes
Procedure time of Rerouting Methodology to a new ROI	Total live procedure time taken to complete bronchoscope navigation to a preselected ROI, including rerouting to a new ROI during navigation.	15 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): September 24, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: September 10, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: bronchoscopy; computer-assisted surgery; surgical navigation; image-guided surgery; robotic bronchoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease
• Other Study ID Numbers: 28052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

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