Lung CancerNCT05599321

Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling

An observational study of Lung Cancer, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: Virtual Navigation System
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 16 Jun 2023to 15 Nov 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

inability to give consent
the CT scan does not meet technical specifications

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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: Lung Cancer
Being tested: Virtual Navigation System
Keywords: bronchoscopy, computer-assisted surgery, image-guided surgery, surgical navigation, image-guided biopsy, multimodal imaging
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Navigation SystemDiagnostic test
The Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. 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.

Study groups in NCT05599321
Study group	Role	What they receive
Historical Controls Cohort		Lung cancer patients who have previously undergone a clinical bronchoscopy. This group represents the current state-of-the-art bronchoscopy practice.
Consented Clinical Bronchoscopy Cohort		Lung cancer patients, scheduled for bronchoscopy, who are consented for bronchoscopy assisted by the Virtual Navigator. Receives: Diagnostic Test: Virtual Navigation System

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Measurement
Presence or absence of adverse events during a procedure
Measured: 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.
Functionality Measurement
Presence or absence of software malfunctions in the VN System during bronchoscopic procedure
Measured: 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.
Diagnostic Biopsy Yield
Comparison of diagnostic biopsy yield between the historical controls and consented live cases
Measured: 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.
Radial Endobronchial Ultrasound (EBUS) Probe Passes
Number of Passes of the Radial Endobronchial Ultrasound (EBUS) Probe per ROI
Measured: 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.
Comparison of the Number of Lymph Nodes and Nodal Stations Visited
Comparison of number of lymph nodes and nodal stations visited between the live cases and historical controls
Measured: 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.

Secondary outcomes (4)

Tumor Pathology
Whether a sample is malignant, non-malignant, or indeterminate and adequacy of sample
Measured: 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.
Procedure Complications
Rate of complications from bronchoscopic procedure
Measured: 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.
Distance From Final Selected Site to the Pre-planned Optimal Site
Distance between actual site selected during the live procedure and the pre-planned, computed optimal biopsy site.
Measured: 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.
Procedure Time
Procedure time (total and per tumor or lymph node) in minutes
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jun 202315 Nov 2024

First posted31 Oct 2022
Study start16 Jun 2023
Primary completion15 Nov 2024
Study completion15 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05599321
Sponsor's protocol ID: 20714
Status last verified: May 2026
First submitted: 13 Oct 2022
Last updated: 15 May 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
Radiation of Neurocranial Region
RecruitingPhase 3
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Non-small Cell Lung Cancer, NSCLC
RecruitingPhase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma
RecruitingPhase 3
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Carcinoma, Non-Small-Cell Lung
Not yet recruitingPhase 1/2
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma

All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling
ClinicalTrials.gov ID: NCT05599321
Acronym / sponsor ID: 20714
Conditions: Lung Cancer
Keywords: bronchoscopy, computer-assisted surgery, image-guided surgery, surgical navigation, image-guided biopsy, multimodal imaging
Study type: Observational
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Penn State UniversityUniversity, hospital or other
Collaborators: Milton S. Hershey Medical Center
Study start: 16 Jun 2023 (actual)
Primary completion: 15 Nov 2024 (actual)
Study completion: 15 Nov 2024 (actual)
First posted: 31 Oct 2022 (actual)
Results: Posted 15 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Historical Controls Cohort	–	–Lung cancer patients who have previously undergone a clinical bronchoscopy. This group represents the current state-of-the-art bronchoscopy practice.
Consented Clinical Bronchoscopy Cohort	–	Diagnostic Test: Virtual Navigation SystemLung cancer patients, scheduled for bronchoscopy, who are consented for bronchoscopy assisted by the Virtual Navigator.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

inability to give consent
the CT scan does not meet technical specifications

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Virtual Navigation SystemThe Virtual Navigator guidance computer is interfaced to the bronchoscopy hardware to tap off the live bronchoscopy and EBUS video feeds. 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.	Diagnostic test	Consented Clinical Bronchoscopy Cohort

Primary outcome

Safety Measurement
Time frame: 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.
Presence or absence of adverse events during a procedure
Functionality Measurement
Time frame: 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.
Presence or absence of software malfunctions in the VN System during bronchoscopic procedure
Diagnostic Biopsy Yield
Time frame: 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.
Comparison of diagnostic biopsy yield between the historical controls and consented live cases
Radial Endobronchial Ultrasound (EBUS) Probe Passes
Time frame: 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.
Number of Passes of the Radial Endobronchial Ultrasound (EBUS) Probe per ROI
Comparison of the Number of Lymph Nodes and Nodal Stations Visited
Time frame: 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.
Comparison of number of lymph nodes and nodal stations visited between the live cases and historical controls

4 secondary outcomes

Tumor Pathology
Time frame: 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.
Procedure Complications
Time frame: 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.
Distance From Final Selected Site to the Pre-planned Optimal Site
Time frame: 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.
Procedure Time
Time frame: 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.

Results and safety

Results posted to the registry on 15 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Historical Controls Cohort - Peripheral Arm	56	56
Consented Clinical Bronchoscopy Cohort - Peripheral Arm	11	9
Historical Controls Cohort - Central Arm	24	24
Consented Clinical Bronchoscopy Cohort - Central Arm	14	13

Primary outcome: Safety Measurement

Time frame: 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.. Number. Unit: Adverse events

Measure	Historical Controls Cohort - Peripheral Arm n = 56	Historical Controls Cohort - Central Arm n = 24	Consented Clinical Bronchoscopy Cohort - Peripheral Arm n = 9	Consented Clinical Bronchoscopy Cohort - Central Arm n = 13
Value	0	0	0	0

Primary outcome: Functionality Measurement

Time frame: 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.. Number. Unit: Software malfunctions

Measure	Historical Controls Cohort - Peripheral Arm n = 0	Consented Clinical Bronchoscopy Cohort - Peripheral Arm n = 9	Historical Controls Cohort - Central Arm n = 0	Consented Clinical Bronchoscopy Cohort - Central Arm n = 13
Value	–	0	–	0

Population analysed: This outcome measure does not apply to the historical control cohort since there was no clinical use of the VN system during these bronchoscopies.

Primary outcome: Diagnostic Biopsy Yield

Time frame: 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.. Number. Unit: Adequate biopsies

Measure	Historical Controls Cohort - Peripheral Arm n = 56	Consented Clinical Bronchoscopy Cohort - Peripheral Arm n = 0	Historical Controls Cohort - Central Arm n = 24	Consented Clinical Bronchoscopy Cohort - Central Arm n = 0
Value	35	–	45	–

Population analysed: This outcome measure is not applicable to the consented clinical bronchoscopy cohort. For the clinical bronchoscopy cohort, we focused on identifying and visualizing the regions of interest.

Primary outcome: Radial Endobronchial Ultrasound (EBUS) Probe Passes

Time frame: 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.. Mean (Full Range). Unit: Number of passes per ROI

Measure	Historical Controls Cohort - Peripheral Arm n = 36	Consented Clinical Bronchoscopy Cohort - Peripheral Arm n = 9	Historical Controls Cohort - Central Arm n = 0	Consented Clinical Bronchoscopy Cohort - Central Arm n = 0
Value	7.7 (0 to 13)	1 (1 to 1)	–	–

Population analysed: The Radial Endobronchial Ultrasound (EBUS) Probe is only used for localizing peripheral lesions and is not used for nodal staging. We note that only 36 of the 56 total patients considered in the Historical Controls Cohort - Peripheral arm used radial probe EBUS.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Historical Controls Cohort - Peripheral Arm	0 of 56 (0%)	0 of 56 (0%)	0 of 56
Consented Clinical Bronchoscopy Cohort - Peripheral Arm	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Historical Controls Cohort - Central Arm	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Consented Clinical Bronchoscopy Cohort - Central Arm	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Limitations and caveats (from the sponsor): Because this was a single-site study, the results are not generalizable. The historical controls were not performed concurrently with the live studies. This could result in differences to the clinical environment, such as changes to the guidance systems, during the time periods for the historical controls and live studies. We performed fewer live studies than originally planned, due to a lack of funds. This affects the statistical significance of the overall results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lung Cancer

Active, not recruitingPhase 2
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
Radiation of Neurocranial Region
RecruitingPhase 3
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Non-small Cell Lung Cancer, NSCLC
RecruitingPhase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma
RecruitingPhase 3
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Carcinoma, Non-Small-Cell Lung
Not yet recruitingPhase 1/2
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William E Higgins, PhD principal investigator

Penn State University, University Park, PA 16802

Rebecca Bascom, MD study director

Penn State Milton S. Hershey Medical Center, Hershey, PA 17033

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Measurement (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05599321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.