NCT04995172

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

Mobile-CT-Assisted Bronchoscopy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo mobile CT-assisted bronchoscopy
OTHER	Electronic Health Record Review	Patients' medical records are reviewed
PROCEDURE	Endobronchial Ultrasound Bronchoscopy	Undergo radial probe EBUS

Timeline

• Start date: 2021-04-19
• Primary completion: 2024-11-27
• Completion: 2024-11-27
• First posted: 2021-08-06
• Last updated: 2024-12-04

Locations

1 site across 1 country: United States