Lung Cancer (Diagnosis)NCT07822126
Accurate Planning and Guidance of Bronchoscopy for Lung Cancer Management
An observational study of Lung Cancer (Diagnosis), run by Penn State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis)
- What is being tested?
- Virtual Navigation System
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Timothy P Sheehan, MS, 717-531-0003 ext. 284024, tsheehan@pennstatehealth.psu.edu
Rebecca Bascom, MD, MPH
About this study
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.
Read more
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)
- Being tested
- Virtual Navigation System
- Keywords
- bronchoscopy, computer-assisted surgery, image-guided surgery, surgical navigation, robotic bronchoscopy
- Medical subject headings
- Lung Neoplasms, Disease
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Consented Clinical Bronchoscopy Cohort | Lung cancer patients, scheduled for bronchoscopy, who are consented for bronchoscopy 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.
Functionality of CTBD Compensation
Establish the functionality of the CTBD compensation methodology during a live guided bronchoscopy to a preselected ROI.
Measured: 15 minutes
Procedure time of CTBD Compensation
Total live procedure time taken to complete bronchoscope navigation to the ROI.
Measured: 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.
Measured: 15 minutes
Procedure time of Rerouting Methodology
Total live procedure time taken to complete bronchoscope navigation to the ROI, including rerouting.
Measured: 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.
Measured: 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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start24 Sep 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William E. Higgins, Penn State University
- Investigators
- William E Higgins, PhD, Principal investigator, Penn State UniversityRebecca Bascom, MD, MPH, Study director, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822126
- Sponsor's protocol ID
- 28052
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accurate Planning and Guidance of Bronchoscopy for Lung Cancer Management
- ClinicalTrials.gov ID
- NCT07822126
- Acronym / sponsor ID
- 28052
- Conditions
- Lung Cancer (Diagnosis)
- Keywords
- bronchoscopy, computer-assisted surgery, image-guided surgery, surgical navigation, robotic bronchoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 24 Sep 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consented Clinical Bronchoscopy Cohort | – | Diagnostic Test: Virtual Navigation SystemLung cancer patients, scheduled for bronchoscopy, who are consented for bronchoscopy 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 (8 listed)
- 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.
- <!-- -->
- Must be able to read, write, and speak English.
Key exclusion criteria (4 listed)
- 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.
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 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. | Diagnostic test | Consented Clinical Bronchoscopy Cohort |
Primary outcome
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.
Procedure time of CTBD Compensation
Time frame: 15 minutes
Total live procedure time taken to complete bronchoscope navigation to the ROI.
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.
Procedure time of Rerouting Methodology
Time frame: 15 minutes
Total live procedure time taken to complete bronchoscope navigation to the ROI, including rerouting.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Lung Cancer (Diagnosis)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
William E Higgins, PhD principal investigator
Penn State University
Rebecca Bascom, MD, MPH study director
Milton S. Hershey Medical Center
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 (Diagnosis), 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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Bascom, MD, MPH (717-531-2925, rbascom@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality of CTBD Compensation (time frame: 15 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.