Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Overall Diagnostic Yield
研究概览
简要总结
The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.
详细描述
This clinical trial examines the effectiveness of a treatment comparing it to another known treatment.
The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease.
The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease.
This research study involves a screening period, a procedure and follow up visits.
The names of the study interventions involved in this study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants ≥18 years old.
- •Participants with lesions having an intermediate pre-test probability of malignancy (pCA, 0.05 to 0.65) as determined by Swensen-Mayo nodule risk calculator and in whom bronchoscopic biopsy was determined to be the next best treatment step by the treating pulmonologist.
- •Participants with higher risk lesions (pCA > 0.65) in need of a diagnosis for nonsurgical treatment or prior to surgery.
- •Participants are willing and able to provide informed consent.
排除标准
- •The participant is pregnant as confirmed by urine or serum pregnancy testing.
- •There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in participant's with a nodule in the outer 1/3 lung zone (i.e. The participant would not go on for a CT guided TTNA).
- •Lacked fitness according to physician judgement to undergo bronchoscopy.
- •Contraindication for temporary interruption of the use of anticoagulant therapy.
- •Uncontrolled or irreversible coagulopathy.
- •Known allergy for lidocaine.
- •Uncontrolled pulmonary hypertension.
- •Recent (< 4 weeks) and/or uncontrolled cardiac disease.
- •Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis such that endobronchial access is considered unsafe).
- •ASA classification ≥
- •COVID-19 positive participant at the time of procedure.
结局指标
主要结局
Overall Diagnostic Yield
时间窗: 6 months
The overall diagnostic yield will be calculated by adding the number of true positives (TP) for both malignancy and benign disease in the numerator and dividing by the total number of procedures performed for each arm of the study. Proportions will be compared with the Chi-Square Test as this test is equivalent to the z-test of two proportions (26). A p-value \<0.05 will be considered as statistically significant.
次要结局
- Overall Incidence of Procedure-related Complications(6 months)
- Additional Diagnostic Procedures in Navigational Bronchoscopy Alone and CBCT Guided Bronchoscopy.(6 Months)
- Navigational Time in Bronchoscopy Alone and CBCT Guided Bronchoscopy.(6 Months)
研究者
Adnan Majid, MD
Principal Investigator
Beth Israel Deaconess Medical Center