Lung Cancer
Conditions
Keywords
bronchoscopy, computer-assisted surgery, image-guided surgery, surgical navigation, image-guided biopsy, multimodal imaging
Brief summary
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.
Interventions
DIAGNOSTIC_TESTVirtual 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.
Sponsors
Penn State University
Milton S. Hershey Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* inability to give consent * the CT scan does not meet technical specifications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Measurement | 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 | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Pathology | 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. | Whether a sample is malignant, non-malignant, or indeterminate and adequacy of sample |
| Procedure 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. | Rate of complications from bronchoscopic procedure |
| Distance From Final Selected Site to the Pre-planned Optimal 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. | Distance between actual site selected during the live procedure and the pre-planned, computed optimal biopsy site. |
| Procedure Time | 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 (total and per tumor or lymph node) in minutes |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilliam E Higgins, PhD
Penn State University, University Park, PA 16802
STUDY_DIRECTORRebecca Bascom, MD
Penn State Milton S. Hershey Medical Center, Hershey, PA 17033
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 92 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 9 | 0 / 24 | 0 / 13 |
| other Total, other adverse events | 0 / 56 | 0 / 9 | 0 / 24 | 0 / 13 |
| serious Total, serious adverse events | 0 / 56 | 0 / 9 | 0 / 24 | 0 / 13 |
Outcome results
None listed