Feasibility of Mobile-CT-Assisted Bronchoscopy for the Diagnosis of Lung Lesion
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About
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.
Full 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.
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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
Trial design
72 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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