Feasibility of Mobile-CT-Assisted Bronchoscopy for the Diagnosis of Lung Lesion

Study Overview
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Brief Summary
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This study investigates whether using a mobile-CT-assisted bronchoscopy (M-CAB) during a bronchoscopy procedure will better enable the study staff to reach the lung tumor, perform a biopsy, and obtain a diagnosis. One method that doctors use for diagnosing lung tumors is bronchoscopy guided by an X-ray machine (called fluoroscope). Though much better guidance could be provided with a CT scanner when compared to the fluoroscope, the standard CT equipment is very large, fixed in a radiology room, and difficult to use with bronchoscopy. Mobile CT imaging systems may more easily and effectively perform the same tasks of the standard CT imaging in the bronchoscopy room, offering better guidance than the standard fluoroscope.

Detailed Description
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PRIMARY OBJECTIVE I. To determine the added value of mobile-CT)-assisted bronchoscopy (M-CAB) for the diagnosis of peripheral lung nodules defined as the proportion of patients in whom bronchoscopy with radial-probe endobronchial ultrasound (RP-EBUS) and 2-D Fluoroscopy is non-diagnostic (lesion is not reached or rapid-onsite cytology is non-diagnostic) and diagnosis is obtained after utilizing mobile-CT assistance. SECONDARY OBJECTIVES: I. Describe the navigational yield of bronchoscopy with RP-EBUS/2-dimensional (2-D) fluoroscopy for peripheral nodules. II. Describe the diagnostic yield of bronchoscopy with RP-EBUS/2-D fluoroscopy for peripheral nodules. III. Describe the mobile-CT (M-CT) added navigational yield. IV. Describe the sensitivity for malignancy of bronchoscopy with RP-EBUS/2-D fluoroscopy and its increase (if any) provided by mobile-CT assistance. V. Describe anatomical and procedural characteristics that can influence navigational and diagnostic yield (tumor location, tumor characteristics -solid, semisolid-, air-bronchus sign, biopsy tool, relationship between biopsy tool/tumor). VI. Describe procedure duration. VII. Describe time required to obtain mobile CT scans VIII. Describe fluoroscopy time and estimate radiation dose to the patient. IX. Describe procedural complications. OUTLINE: Patients undergo RP-EBUS bronchoscopy per standard of care. If the study staff cannot reach the target lesion or is unable to determine a diagnosis, patients undergo bronchoscopy using mobile CT imaging. Patients' medical records are also reviewed for up to 6 months.

Official Title
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Mobile-CT-Assisted Bronchoscopy

Conditions
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Lung Neoplasm

Intervention / Treatment
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* Procedure: Computed Tomography
* Other: Electronic Health Record Review
* Procedure: Endobronchial Ultrasound Bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of 18 years of age or older undergoing bronchoscopy for diagnosis of a peripheral lung lesion from 1 to 3.5 cm in diameter located in the outer 2/3 of the lung fields Exclusion Criteria: Pregnant or breastfeeding women Patients who cannot tolerate raising both arms above their head (position for obtaining mobile-CT images) Patients with any contraindication 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (CT-assisted bronchoscopy, chart review)<br>Patients undergo RP-EBUS bronchoscopy per standard of care. If the study staff cannot reach the target lesion or is unable to determine a diagnosis, patients undergo bronchoscopy using mobile CT imaging. Patients' medical records are also reviewed for up to 6 months. | Procedure: Computed Tomography<br>* Undergo mobile CT-assisted bronchoscopy<br>* Other names: tomography;Other: Electronic Health Record Review<br>* Patients' medical records are reviewed<br>Procedure: Endobronchial Ultrasound Bronchoscopy<br>* Undergo radial probe EBUS<br>* Other names: Endobronchial Ultrasound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The added value of mobile-computed tomography (CT)-assisted bronchoscopy (M-CAB) | Defined as the proportion of patients in whom bronchoscopy with thin or ultrathin scope, radial-probe endobronchial ultrasound (RP-EBUS) and 2-dimensional (2-D) fluoroscopy is non-diagnostic (lesion is not reached or rapid-onsite cytology is non-diagnostic) and diagnosis is obtained after utilizing mobile-CT assistance. Descriptive statistics (mean standard deviation [SD] or median interquartile range [IQR], frequency [%]) will be used to summarize patient characteristics. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Navigational yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules | Navigational yield for standard of care (SOC) will be estimated along with 95% confidence intervals (CIs). | Up to 6 months | 
| Diagnostic yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules | Diagnostic yield of SOC and diagnostic yield of SOC + M-CT along with their 95% CIs will be estimated. | Up to 6 months | 
| Mobile-CT (M-CT) added navigational yield | M-CT added diagnostic yield in a subgroup with non-diagnostic subjects by SOC will be estimated along with its 95% CI. M-CT added diagnostic yield in a subgroup with non-diagnostic subjects by SOC will be estimated along with its 95% CI. Two-sided exact binomial test will be used to test if diagnostic yield of SOC + M-CT is significantly different from 0.2 in the subgroup. | Up to 6 months | 
| Sensitivity for malignancy of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy and its increase (if any) provided by mobile-CT assistance | Sensitivity for malignancy of SOC and sensitivity for malignancy of SOC + M-CT will be estimated, considering final pathology as the gold standard test. | Up to 6 months | 
| Anatomical and procedural characteristics that can influence navigational and diagnostic yield | Anatomic and procedural characteristics that are associated with navigational and diagnostic yield will be evaluated by multivariate logistic regression models. A p-value of less than 0.05 will indicate a statistical significance. | Up to 6 months | 
| Procedure duration | Will be summarized by mean (standard deviation [SD]) or median (interquartile range [IQR]). | Up to 6 months | 
| Time required to obtain mobile CT scans | Will be summarized by mean (SD) or median (IQR). | Up to 6 months | 
| Fluoroscopy time | Will be summarized by mean (SD) or median (IQR). | Up to 6 months | 
| Radiation dose to the patient | Will be summarized by mean (SD) or median (IQR). | Up to 6 months | 
| Procedural complications | Complications will be tabulated. | Up to 6 months |