Accurate Planning and Guidance of Bronchoscopy for Lung Cancer Management
ConditionLung Cancer (Diagnosis)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPenn State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
CT/PET study OR
Disqualifiers
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 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Virtual Navigation System
Diagnostic testThe 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.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Consented Clinical Bronchoscopy Cohort1 intervention
Trial outcomes
Primary outcomes
1
Functionality of CTBD Compensation
Establish the functionality of the CTBD compensation methodology during a live guided bronchoscopy to a preselected ROI.
Time frame
15 minutes2
Procedure time of CTBD Compensation
Total live procedure time taken to complete bronchoscope navigation to the ROI.
Time frame
15 minutes3
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.
Time frame
15 minutes4
Procedure time of Rerouting Methodology
Total live procedure time taken to complete bronchoscope navigation to the ROI, including rerouting.
Time frame
15 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: