Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07822126

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Lung Cancer (Diagnosis) Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location contact

Rebecca Bascom, MD, MPH

SUB_INVESTIGATOR

Timothy P Sheehan, MS

CONTACT

[email protected]

717-531-0003 ext. 284024

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

<!-- -->

  • CT/PET study OR
  • a clinical CT scan that includes inspiratory and expiratory images
  • Must be able to read, write, and speak English.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Functionality of CTBD Compensation

    Time frame: 15 minutes

    Establish the functionality of the CTBD compensation methodology during a live guided bronchoscopy to a preselected ROI.

  2. Procedure time of CTBD Compensation

    Time frame: 15 minutes

    Total live procedure time taken to complete bronchoscope navigation to the ROI.

  3. Functionality of Rerouting Methodology

    Time frame: 15 minutes

    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.

  4. Procedure time of Rerouting Methodology

    Time frame: 15 minutes

    Total live procedure time taken to complete bronchoscope navigation to the ROI, including rerouting.

  5. Functionality of Rerouting to a new ROI

    Time frame: 15 minutes

    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.

  6. Procedure time of Rerouting Methodology to a new ROI

    Time frame: 15 minutes

    Total live procedure time taken to complete bronchoscope navigation to a preselected ROI, including rerouting to a new ROI during navigation.

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Bascom, MD, MPH

CONTACT

[email protected]

717-531-2925

William E Higgins, PhD

CONTACT

[email protected]

814-865-0186

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.