RECRUITING

Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Piloting a Virtual Navigation (VN) System for Bronchoscopic Lung Nodule Sampling

Quick Facts

Study Start:2023-06-16
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05599321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * patients from age 18 and over
  2. * a planned clinical bronchoscopy to evaluate abnormal lung parenchyma and/or central chest lymph nodes
  3. * a clinical CT scan performed at Hershey Medical Center that meets technical specifications and is available on the Radiology research server
  4. * (Optional, use if available) CT/PET images that meet technical specifications and are available on the Hershey Medical Center clinical image storage system
  1. * inability to give consent
  2. * the CT scan does not meet technical specifications

Contacts and Locations

Study Contact

Rebecca Bascom, MD
CONTACT
717-531-2925
rbascom@pennstatehealth.psu.edu
William E Higgins, PhD
CONTACT
814-865-0186
weh2@psu.edu

Principal Investigator

William E Higgins, PhD
PRINCIPAL_INVESTIGATOR
Penn State University, University Park, PA 16802
Rebecca Bascom, MD
STUDY_DIRECTOR
Penn State Milton S. Hershey Medical Center, Hershey, PA 17033

Study Locations (Sites)

Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Penn State University

  • William E Higgins, PhD, PRINCIPAL_INVESTIGATOR, Penn State University, University Park, PA 16802
  • Rebecca Bascom, MD, STUDY_DIRECTOR, Penn State Milton S. Hershey Medical Center, Hershey, PA 17033

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-16
Study Completion Date2025-10

Study Record Updates

Study Start Date2023-06-16
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • bronchoscopy
  • computer-assisted surgery
  • image-guided surgery
  • surgical navigation
  • image-guided biopsy
  • multimodal imaging

Additional Relevant MeSH Terms

  • Lung Cancer