Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 14
- 主要终点
- Diagnostic Accuracy
研究概览
简要总结
This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy:
- a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and
- navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.
详细描述
Endpoints:
Primary:
• To evaluate diagnostic accuracy through 12 months of clinical follow-up
Secondary:
- To evaluate rate of pneumothorax.
- To evaluate rate of pneumothorax requiring chest tube placement.
- To evaluate clinically significant bleeding (defined by bleeding requiring intervention).
- To evaluate need for hospitalization after procedure.
- To evaluate duration of the procedure.
- To evaluate procedural factors associated with improved yield (type of biopsy, number of biopsies, use of radial ultrasound, presence of a bronchus sign, biopsy site).
- To evaluate need for additional nodule biopsy.
- To evaluate need for additional procedure for staging.
- To evaluate radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy.
- To evaluate need for F-Nav (digital tomosynthesis) during navigation bronchoscopy.
- To evaluate diagnostic yield
- To evaluate the rate at which the biopsy procedure yields a confident clinical diagnosis (including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens).
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
- 否
入选标准
- •Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of malignancy:
- •Intermediate pre-test probability of malignancy as defined by a pre-test probability of malignancy between 10% and 100%, using a validated clinical prediction model, which is either:
- •The Brock model14 if no PET scan data are available, or
- •The Herder model15 if PET-CT data are available.
- •Size between 10 and 30 mm (long diameter).
- •Location peripheral, here defined as occupying the middle or outer third lung zones.
- •Accessible via navigation bronchoscopy and also accessible via CT-guided biopsy (i.e. the nodule is clinically suited to equal access by either procedure), as confirmed by an independent interventional panel.
排除标准
- •Patients with proximal nodules, as defined by nodules present in the proximal 1/3 of the lung by dedicated software analysis (described below) will not be eligible for the study.
- •Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).
研究组 & 干预措施
Navigation Bronchoscopy (NB) with F-Nav
干预措施: Navigation bronchoscopy (Device)
CT-guided Biopsy
干预措施: CT-Guided Biopsy (Device)
结局指标
主要结局
Diagnostic Accuracy
时间窗: Up to 12 months
Proportion of biopsies leading to a definitive diagnosis, comparing the bronchoscopy pathway to the CT-guided biopsy pathway. Definitive diagnoses are pre-defined as any of the following: * Malignant, OR * Abnormal tissue (excluding normal or absence of lung parenchyma) followed by a surgical lung biopsy yielding the same histological diagnosis, OR * Specific benign histopathologic finding which accounts for the presence of a lung nodule (specifically including organizing pneumonia, frank purulence, granulomatous inflammation, or other specific benign finding) AND * Absence of malignancy (true negative) through 1-year CT follow-up, defined as: * The nodule markedly regresses or resolves on follow-up imaging, OR * A persistent nodule has not been diagnosed as malignant, AND * No plans for repeat invasive diagnostic procedures through 12 months follow-up. Normal or absence of lung parenchyma, atypia and non-specific inflammation will be considered non-diagnostic.
次要结局
- Diagnostic Yield(Up to 12 months)
- Rate of Pneumothorax(Up to 12 months)
- Rate of Pneumothorax Requiring Chest Tube Placement(Up to 12 months)
- Need for Hospitalization After Procedure(Up to 12 months)
- Duration of Procedure(Up to 12 months)
- Procedural Factors Associated With Improved Yield (Type of Biopsy)(Up to 12 months)
- Procedural Factors Associated With Improved Yield (Number of Biopsies)(Up to 12 months)
- Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound)(Up to 12 months)
- Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign)(Up to 12 months)
- Procedural Factors Associated With Improved Yield (Biopsy Site)(Up to 12 months)
- Need for Additional Nodule Biopsy(Up to 12 months)
- Need for Additional Procedure for Staging(Up to 12 months)
- Radiation Exposure From Fluoroscopy-guided Bronchoscopy(Up to 12 months)
- Need for F-Nav During Navigation Bronchoscopy(Up to 12 months)
- Confident Clinical Diagnosis(Up to 12 months)
- Radiation Exposure From CT for CT-guided Biopsy(Up to 12 months)
- Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group(Up to 12 months)
研究者
Fabien Maldonado
Principal Investigator
Vanderbilt-Ingram Cancer Center