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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Recruitment Status : Withdrawn (Was unable to enroll any participants)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

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.

Condition or disease Intervention/treatment Phase
Peripheral Lung Lesions Procedure: Conventional bronchoscopy Device: VIDA Pulmonary Workstation 2 Procedure: Biopsy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Localization of Peripheral Pulmonary Lesions: A Pilot Study
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.
Procedure: Conventional bronchoscopy
-Standard of care

Device: VIDA Pulmonary Workstation 2
-Virtual bronchoscopic navigation system

Procedure: Biopsy
-Standard of care




Primary Outcome Measures :
  1. Localization of peripheral pulmonary lesions as confirmed using radial probe endobronchial ultrasound [ Time Frame: At the time of bronchoscopy (day 1) ]

Secondary Outcome Measures :
  1. Rate of lesion localization using a conventional chest CT as a reference only [ Time Frame: At the time of bronchoscopy (day 1) ]
  2. 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) ]
  3. Time to localization of peripheral pulmonary lesions [ Time Frame: At the time of bronchoscopy (day 1) ]
  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536026


Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Alexander Chen, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03536026    
Other Study ID Numbers: 201711034
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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