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

Completed

• Conditions: Lung Neoplasm
• Interventions: Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Endobronchial Ultrasound Bronchoscopy

• Registration Number: NCT04995172
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-04-19
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-06
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (CT-assisted bronchoscopy, chart review)	Computed Tomography	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.
Observational (CT-assisted bronchoscopy, chart review)	Electronic Health Record Review	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.
Observational (CT-assisted bronchoscopy, chart review)	Endobronchial Ultrasound Bronchoscopy	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.

Primary Outcome Measures

Name	Time	Method
The added value of mobile-computed tomography (CT)-assisted bronchoscopy (M-CAB)	Up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity for malignancy of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy and its increase (if any) provided by mobile-CT assistance	Up to 6 months	Sensitivity for malignancy of SOC and sensitivity for malignancy of SOC + M-CT will be estimated, considering final pathology as the gold standard test.
Fluoroscopy time	Up to 6 months	Will be summarized by mean (SD) or median (IQR).
Anatomical and procedural characteristics that can influence navigational and diagnostic yield	Up to 6 months	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.
Procedure duration	Up to 6 months	Will be summarized by mean (standard deviation \[SD\]) or median (interquartile range \[IQR\]).
Diagnostic yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules	Up to 6 months	Diagnostic yield of SOC and diagnostic yield of SOC + M-CT along with their 95% CIs will be estimated.
Time required to obtain mobile CT scans	Up to 6 months	Will be summarized by mean (SD) or median (IQR).
Radiation dose to the patient	Up to 6 months	Will be summarized by mean (SD) or median (IQR).
Navigational yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules	Up to 6 months	Navigational yield for standard of care (SOC) will be estimated along with 95% confidence intervals (CIs).
Mobile-CT (M-CT) added navigational yield	Up to 6 months	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.
Procedural complications	Up to 6 months	Complications will be tabulated.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States