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Not yet recruitingNCT07822126Updated Sep 16, 2026

Accurate Planning and Guidance of Bronchoscopy for Lung Cancer Management

An observational study in Lung Cancer (Diagnosis), sponsored by Penn State University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Penn State University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
6
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer (Diagnosis)

Keywords

  • bronchoscopy
  • computer-assisted surgery
  • image-guided surgery
  • surgical navigation
  • robotic bronchoscopy
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 6 is below the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Penn State University is the lead sponsor of 270 studies on the registry; 53 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.

Browse Penn State University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

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    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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
6 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testVirtual 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.

06

What researchers measure

Primary outcomes

  1. Functionality of CTBD Compensation

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

    Time frame: 15 minutes

  2. Procedure time of CTBD Compensation

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

    Time frame: 15 minutes

  3. 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.

    Time frame: 15 minutes

  4. Procedure time of Rerouting Methodology

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

    Time frame: 15 minutes

  5. 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.

    Time frame: 15 minutes

  6. 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.

    Time frame: 15 minutes

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.

Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's planned 8 months is below that.

Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 16, 2026
StartEst.
Sep 24, 2026
Primary completionEst.
May 31, 2027
CompletionEst.
May 31, 2027
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07822126
Lead sponsor
Penn State University
Responsible party
William E. Higgins (Distinguished Professor, Penn State University) — Principal investigator
First posted
Sep 16, 2026
Start date
Sep 24, 2026 (estimated)
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Rebecca Bascom, MD, MPH
Contact
rbascom@pennstatehealth.psu.edu
717-531-2925
William E Higgins, PhD
Contact
weh2@psu.edu
814-865-0186
William E Higgins, PhD
principal investigator · Penn State University
Rebecca Bascom, MD, MPH
study director · Milton S. Hershey Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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