- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536026
Localization of Peripheral Pulmonary Lesions: A Pilot Study
December 18, 2018 updated by: Washington University School of Medicine
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
-Standard of care
-Virtual bronchoscopic navigation system
-Standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Localization of peripheral pulmonary lesions as confirmed using radial probe endobronchial ultrasound
Time Frame: At the time of bronchoscopy (day 1)
|
At the time of bronchoscopy (day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of lesion localization using a conventional chest CT as a reference only
Time Frame: At the time of bronchoscopy (day 1)
|
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)
|
At the time of bronchoscopy (day 1)
|
|
Time to localization of peripheral pulmonary lesions
Time Frame: At the time of bronchoscopy (day 1)
|
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.
|
At the time of bronchoscopy (day 1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alexander Chen, M.D., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start (Actual)
April 30, 2018
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
May 14, 2018
First Submitted That Met QC Criteria
May 14, 2018
First Posted (Actual)
May 24, 2018
Study Record Updates
Last Update Posted (Actual)
December 20, 2018
Last Update Submitted That Met QC Criteria
December 18, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 201711034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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