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| Name | Class |
|---|---|
| Milton S. Hershey Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Navigation System | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Measurement | Presence or absence of adverse events during a procedure | 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 | 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 | 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Pathology | Whether a sample is malignant, non-malignant, or indeterminate and adequacy of sample | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| William E Higgins, PhD | Penn State University, University Park, PA 16802 | Principal Investigator |
| Rebecca Bascom, MD | Penn State Milton S. Hershey Medical Center, Hershey, PA 17033 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Historical Controls Cohort - Peripheral Arm | Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice. |
| FG001 | Consented Clinical Bronchoscopy Cohort - Peripheral Arm | Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator. Virtual Navigation System: 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. |
| FG002 | Historical Controls Cohort - Central Arm | Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice. |
| FG003 | Consented Clinical Bronchoscopy Cohort - Central Arm | Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. Virtual Navigation System: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis population is based on the number of clinical regions of interest (ROIs) considered for a particular study arm. For the two peripheral arms, an ROI was either a suspect tumor or blood vessel segment (consented clinical cohort only). For the two central arms, an ROI was either a lymph node or an International Association for the Study of Lung Cancer (IASLC) defined nodal station.
| ID | Title | Description |
|---|---|---|
| BG000 | Historical Controls Cohort - Peripheral Arm | Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice. |
| BG001 | Consented Clinical Bronchoscopy Cohort - Peripheral Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety Measurement | Presence or absence of adverse events during a procedure | Posted | Number | Adverse events | 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. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Historical Controls Cohort - Peripheral Arm | Lung cancer patients who have previously undergone a clinical bronchoscopy for peripheral nodule biopsy. This group represents the current state-of-the-art bronchoscopy practice. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William E. Higgins | The Pennsylvania State University | 814-865-0186 | weh2@psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2024 | Oct 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2024 | Oct 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
Rate of complications from bronchoscopic procedure |
| 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. | 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 | 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. |
Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator. Virtual Navigation System: 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. |
| BG002 | Historical Controls Cohort - Central Arm | Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice. |
| BG003 | Consented Clinical Bronchoscopy Cohort - Central Arm | Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. Virtual Navigation System: 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. |
| BG004 | Total | Total of all reporting groups |
| Regions of interest (ROI) |
|
| Participants |
| No |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No | Participants |
|
| OG002 | Consented Clinical Bronchoscopy Cohort - Peripheral Arm | Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator. Virtual Navigation System: 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. |
| OG003 | Consented Clinical Bronchoscopy Cohort - Central Arm | Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. Virtual Navigation System: 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. |
|
|
| Primary | Functionality Measurement | Presence or absence of software malfunctions in the VN System during bronchoscopic procedure | This outcome measure does not apply to the historical control cohort since there was no clinical use of the VN system during these bronchoscopies. | Posted | Number | Software malfunctions | 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. | ROI | ROI |
|
|
|
| Primary | Diagnostic Biopsy Yield | Comparison of diagnostic biopsy yield between the historical controls and consented live cases | 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. | Posted | Number | Adequate biopsies | 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. | ROI | ROI |
|
|
|
| Primary | Radial Endobronchial Ultrasound (EBUS) Probe Passes | Number of Passes of the Radial Endobronchial Ultrasound (EBUS) Probe per ROI | 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. | Posted | Mean | Full Range | Number of passes per ROI | 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. | ROI | ROI |
|
|
|
| Primary | 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 | This is not applicable to the peripheral arms of both cohorts because lymph nodes and nodal stations are not visited during those procedures. The peripheral arms are concerned with diagnosis of peripheral lesions. | Posted | Mean | Full Range | Nodes and stations visited per case | 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 | Tumor Pathology | Whether a sample is malignant, non-malignant, or indeterminate and adequacy of sample | 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. We note that the 45 participants analyzed in the Historical Controls Cohort - Peripheral Arm is less than the 56 participants considered for this arm; this information was not available for all of the historical cases. | Posted | Number | ROI | 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. | ROI | ROI |
|
|
|
| Secondary | Procedure Complications | Rate of complications from bronchoscopic procedure | Posted | Number | Complications | 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 | 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. | This outcome measure was not available in the historical control dataset. Also, this outcome measure only applies to the peripheral arm, which focuses on peripheral lesions, and therefore was not collected for the central arm, which does not consider peripheral lesions. The central arm focused on locating lymph node stations, not distance to the sites. | Posted | Mean | Full Range | distance in millimeters | 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. | Biopsy sites | Biopsy sites |
|
|
|
| Secondary | Procedure Time | Procedure time (total and per tumor or lymph node) in minutes | Posted | Mean | Full Range | Seconds | 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. | ROI | ROI |
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Consented Clinical Bronchoscopy Cohort - Peripheral Arm | Lung cancer patients, scheduled for bronchoscopy with peripheral nodule biopsy, who are consented for bronchoscopy assisted by the Virtual Navigator. Virtual Navigation System: 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Historical Controls Cohort - Central Arm | Lung cancer patients who have previously undergone a clinical bronchoscopy for central nodal staging. This group represents the current state-of-the-art bronchoscopy practice. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | Consented Clinical Bronchoscopy Cohort - Central Arm | Lung cancer patients, scheduled for bronchoscopy with central nodal staging, who are consented for bronchoscopy assisted by the Virtual Navigator. Virtual Navigation System: 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| ROI |
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| ROI |
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| ROI |
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| ROI |
|
| Non-malignant |
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| Inadequate |
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| Biopsy sites |
|
| ROI |
|