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Localization of Peripheral Pulmonary Lesions: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536026
Recruitment Status : Withdrawn (Was unable to enroll any participants)
First Posted : May 24, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE May 14, 2018
First Posted Date  ICMJE May 24, 2018
Last Update Posted Date December 20, 2018
Actual Study Start Date  ICMJE April 30, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Localization of Peripheral Pulmonary Lesions: A Pilot Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Lung Lesions
Intervention  ICMJE
  • Procedure: Conventional bronchoscopy
    -Standard of care
  • Device: VIDA Pulmonary Workstation 2
    -Virtual bronchoscopic navigation system
  • Procedure: Biopsy
    -Standard of care
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 18, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)
20
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT03536026
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander Chen, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP