Lung Cancer (Diagnosis)
Conditions
Keywords
bronchoscopy, computer-assisted surgery, image-guided surgery, surgical navigation, robotic bronchoscopy
Brief 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.
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.
Sponsors
Penn State University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: <!-- --> 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functionality of CTBD Compensation | 15 minutes | Establish the functionality of the CTBD compensation methodology during a live guided bronchoscopy to a preselected ROI. |
| Procedure time of CTBD Compensation | 15 minutes | Total live procedure time taken to complete bronchoscope navigation to the ROI. |
| Functionality of Rerouting Methodology | 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 | 15 minutes | Total live procedure time taken to complete bronchoscope navigation to the ROI, including rerouting. |
| Functionality of Rerouting to a new ROI | 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 | 15 minutes | Total live procedure time taken to complete bronchoscope navigation to a preselected ROI, including rerouting to a new ROI during navigation. |
Countries
United States
Contacts
CONTACTRebecca Bascom, MD, MPH
CONTACTWilliam E Higgins, PhD
PRINCIPAL_INVESTIGATORWilliam E Higgins, PhD
Penn State University
STUDY_DIRECTORRebecca Bascom, MD, MPH
Milton S. Hershey Medical Center
Outcome results
None listed