Localization of Peripheral Pulmonary Lesions: A Pilot Study

• ClinicalTrials.gov Identifier: NCT03536026
• Recruitment Status: Withdrawn
• First Posted: May 24, 2018
• Last Update Posted: December 20, 2018
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Washington University School of Medicine

Tracking Information

• First Submitted Date: May 14, 2018
• First Posted Date: May 24, 2018
• Last Update Posted Date: December 20, 2018
• Actual Study Start Date: April 30, 2018
• Actual Primary Completion Date: November 1, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 14, 2018): Localization of peripheral pulmonary lesions as confirmed using radial probe endobronchial ultrasound [ Time Frame: At the time of bronchoscopy (day 1) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 24, 2018)

• Rate of lesion localization using a conventional chest CT as a reference only [ Time Frame: At the time of bronchoscopy (day 1) ]
• Rate of lesion localization using virtual bronchoscopic navigation if needed (failed lesion localization using conventional chest CT only) [ Time Frame: At the time of bronchoscopy (day 1) ]
• Time to localization of peripheral pulmonary lesions [ Time Frame: At the time of bronchoscopy (day 1) ]
• Diagnostic yield of procedures [ Time Frame: At the time of bronchoscopy (day 1) ]
  -Diagnostic yield based on final cytology and/or histopathology will be determined from the results of the bronchoscopy. A biopsy that results in a specific diagnosis, either malignant or benign, that adequately explains the clinical scenario as determined by the treating physician, will be considered truly positive.

Original Secondary Outcome Measures (submitted: May 14, 2018)

• Rate of lesion localization using a conventional chest CT as a reference only [ Time Frame: At the time of bronchoscopy (day 1) ]
• Rate of lesion localization using virtual bronchoscopic navigation if needed (failed lesion localization using conventional chest CT only) [ Time Frame: At the time of bronchoscopy (day 1) ]
• Time to localization of peripheral pulmonary lesions [ Time Frame: At the time of bronchoscopy (day 1) ]
• Diagnostic yield of procedures [ Time Frame: At the time of bronchoscopy (day 1) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Localization of Peripheral Pulmonary Lesions: A Pilot Study
• Official Title: Localization of Peripheral Pulmonary Lesions: A Pilot Study
• Brief Summary: Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. One significant barrier for the bronchoscopic biopsy of peripheral lesions is the ability to reliably locate peripheral lesions in an efficient manner. The majority of the published literature regarding peripheral lesion biopsy has used diagnostic yield as the primary endpoint. Based on this data, it is unclear if non-diagnostic procedures are due to the inability to locate peripheral lesions, or due to the inability to successfully biopsy lesions once located using currently available instruments. This study will evaluate the bronchoscopists' ability to locate peripheral pulmonary lesions by using a conventional chest computed tomography (CT) scan as a reference and a virtual bronchoscopic navigational system, if needed, for the localization of peripheral pulmonary lesions.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Peripheral Lung Lesions

Intervention

• Procedure: Conventional bronchoscopy
  -Standard of care
• Device: VIDA Pulmonary Workstation 2
  -Virtual bronchoscopic navigation system
• Procedure: Biopsy
  -Standard of care

Study Arms

Experimental: Bronchoscopic evaluation and biopsy

-Bronchoscopy will be performed by pulmonary and/or critical care fellows who have performed fewer than 10 bronchoscopies (inexperienced bronchoscopists) under direct supervision by an attending Interventional Pulmonologist. The inexperienced bronchoscopist will attempt to navigate to the targeted peripheral pulmonary lesion without virtual bronchoscopic navigation, using only standard axial CT images as a reference. The attending physician will directly observe, but will provide no guidance during this period, which will last no longer than 10 minutes. If the lesion is located and confirmed with radial probe endobronchial ultrasound prior to 10 minutes, biopsies will be performed as per routine clinical practice. If the 10 minute time period elapses prior to localization of the peripheral pulmonary lesion, virtual bronchoscopic navigation will be used.

Interventions:

• Procedure: Conventional bronchoscopy
• Device: VIDA Pulmonary Workstation 2
• Procedure: Biopsy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 18, 2018): 0
• Original Estimated Enrollment (submitted: May 14, 2018): 20
• Actual Study Completion Date: November 1, 2018
• Actual Primary Completion Date: November 1, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with peripheral lung lesions 1-5cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
• Are at least 18 years old
• Are able to provide informed consent
• Have CT scans within 30 days suitable for use with the virtual bronchoscopic system

Exclusion Criteria:

• Patients who refuse to participate
• Are less than 18 years of age
• Are pregnant
• Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
• Are unable to provide informed consent

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT03536026
• Other Study ID Numbers: 201711034
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Washington University School of Medicine
• Study Sponsor: Washington University School of Medicine
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alexander Chen, M.D.; Washington University School of Medicine

• PRS Account: Washington University School of Medicine
• Verification Date: December 2018