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Not Yet Recruiting NCT07822126

Accurate Planning and Guidance of Bronchoscopy for Lung Cancer Management

Conditions: Lung Cancer (Diagnosis)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 6
Sponsor: Penn State University

Location: Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07822126). StuddyBuddy aggregates publicly available trial information.