Accurate Planning and Guidance of Bronchoscopy for Lung Cancer Management

NCT07822126 | Not Yet Recruiting

• 1 other identifier: 28052
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer (Diagnosis)

Keywords

bronchoscopy; computer-assisted surgery; image-guided surgery; surgical navigation; robotic bronchoscopy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Consented Clinical Bronchoscopy Cohort

Lung cancer patients, scheduled for bronchoscopy, who are consented for bronchoscopy 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 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.

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:

• a planned clinical bronchoscopy to evaluate abnormal lung parenchyma and/or central chest lymph nodes;
• 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.
• a clinical CT scan performed at Hershey Medical Center, AND
• Either one of two additional clinically available scans:
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• CT/PET study OR
• a clinical CT scan that includes inspiratory and expiratory images
• Must be able to read, write, and speak English.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William E Higgins, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

• Rebecca Bascom, MD, MPH

  Milton S. Hershey Medical Center

  STUDY DIRECTOR

Central Study Contacts

Rebecca Bascom, MD, MPH

CONTACT

717-531-2925; rbascom@pennstatehealth.psu.edu

William E Higgins, PhD

CONTACT

814-865-0186; weh2@psu.edu

Study Design

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

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: September 24, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)