CBCT in Guiding Bronchoscopy in Patients With Lung Lesions

Study Overview
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Brief Summary
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This pilot clinical trial studies how well cone-beam computed tomography (CBCT) works in guiding bronchoscopy in patients with lung lesions. CBCT during bronchoscopy may help doctors to biopsy lung lesions that are harder to reach.

Detailed Description
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PRIMARY OBJECTIVES: I. To describe the feasibility of using CBCT as an additional aid to guided-bronchoscopy with radial probe endobronchial ultrasound (RP-EBUS)/hybrid scope for the diagnosis of peripheral lung nodules. SECONDARY OBJECTIVES: I. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS (RP-EBUS-navigation yield) and confirmed with CBCT. II. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS and samples are diagnostic (diagnostic yield-RP-EBUS). III. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is identified by RP-EBUS, samples were non-diagnostic, and CBCT prompted further tool re-location (i.e. change of needle angle, change of tool) leading to diagnosis. IV. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is not identified by RP-EBUS, and CBCT-aided navigation allowed the operator to reach the lesion (CBCT-added navigation yield). V. Describe the proportion of patients with peripheral nodules undergoing bronchoscopy in whom the lesion is not identified by RP-EBUS and CBCT-aided navigation allowed the operator to reach the lesion and obtain a diagnosis (CBCT-added diagnostic yield). VI. Describe the relationship between RP-PROBE and target (contact/no contact; central/peripheral). VII. Describe the relationship between needle tip and target (contact/no contact; central/peripheral). VIII. Describe the influence of points 6 and 7 on diagnostic yield. IX. Describe fluoroscopy time. X. Describe estimated amount of radiation generated by CBCT use. XI. Describe bronchoscopy time (first scope in/last scope out). XII. Describe the proportion of patients in whom molecular analysis for lung cancer (i.e. EGFR, K-RAS, ALK) can be performed. OUTLINE: Patients undergo CBCT during standard of care bronchoscopy. After completion of study, patients with lesions found not to be cancerous are followed up for 6 months to watch for changes (standard care).

Official Title
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A New Guide for Our Guided-Bronchoscopy: The Use of Cone-Beam CT to Enhance Navigation and Diagnostic Yield of RP-EBUS and Hybrid Bronchoscope for Peripheral Lung Nodules Suspicious for Malignancy: A Pilot Study

Conditions
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Pulmonary Mass

Intervention / Treatment
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* Procedure: Cone-Beam Computed Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing guided-bronchoscopy for diagnosis of peripheral lung lesion/s > 1 and < 3 cm in diameter located in the outer 2/3 of the lung fields Exclusion Criteria: Pregnant or breastfeeding women Patient with indications for mediastinal lymph node (LN) sampling per 13th American College of Clinical Pharmacy (ACCP) guidelines Patient with metastatic disease (from primaries other than lung) who have suspicious mediastinal or hilar LN that require sampling Patients with contraindication/s for general anesthesia (e.g., severe and active coronary artery disease, chronic obstructive pulmonary disease [COPD] with forced expiratory volume in 1 second [FEV1] < 1 liter, uncontrolled hypertension, increased intracranial pressure, history of intolerance to general anesthesia) Dementia or other severe cognitive impairment causing inability to understand or consent to the procedure and study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (CBCT)<br>Patients undergo CBCT during standard of care bronchoscopy. | Procedure: Cone-Beam Computed Tomography<br>* Undergo CBCT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility based on percentage of patients where researchers can locate target and bronchoscopic tools with cone-beam computed tomography | Will be considered feasible if researchers can locate target and bronchoscopic tools with cone-beam computed tomography in at least 80% of the patients (16 out of the 20 participants) that are enrolled. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with peripheral nodules undergoing bronchoscopy in different subsample | Will conduct extensive descriptive analyses of the data collected. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate. | Up to 6 months | 
| Localization of the tip with respect to targets | Will assess the relationship between radial probe/needle tip and target. Will conduct extensive descriptive analyses of the data collected. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate. | Up to 6 months | 
| Diagnostic yield | Will assess the influence of points 6 and 7 on diagnostic yield. Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate. | Up to 6 months | 
| Amount of radiation generated by cone-beam computed tomography use | Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate. | Up to 6 months | 
| Fluoroscopy/bronchoscopy time | Descriptive statistics (e.g., frequencies, ranges, means, proportions, standard deviations, and measures of skewness and kurtosis), including 90% confidence intervals will be calculated. Will closely examine distribution characteristics of the variables using box plots, histograms, and scatter plots, where appropriate. | Up to 6 months |