Mobile-CT-Assisted Bronchoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The added value of mobile-computed tomography (CT)-assisted bronchoscopy (M-CAB)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The added value of mobile-computed tomography (CT)-assisted bronchoscopy (M-CAB)
时间窗: 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.
次要结局
- 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)
- Fluoroscopy time(Up to 6 months)
- Anatomical and procedural characteristics that can influence navigational and diagnostic yield(Up to 6 months)
- Procedure duration(Up to 6 months)
- Diagnostic yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules(Up to 6 months)
- Time required to obtain mobile CT scans(Up to 6 months)
- Radiation dose to the patient(Up to 6 months)
- Navigational yield of thin/ultrathin scope/RP-EBUS/2-D fluoroscopy for peripheral nodules(Up to 6 months)
- Mobile-CT (M-CT) added navigational yield(Up to 6 months)
- Procedural complications(Up to 6 months)