nCLE Guided Randomized Controlled Trial for Lung Cancer Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- First-pass Diagnostic Yield
研究概览
简要总结
This clinical trial compares the addition of needle-based confocal laser endomicroscopy (nCLE) and fluorescein to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) with EBUS TBNA alone for the diagnosis of lung cancer in patients with peripheral pulmonary nodules. EBUS TBNA is a diagnostic procedure that can be used to sample lung tissue. nCLE is a novel high-resolution imaging technique that uses a laser light to create real-time microscopic images of tissues. It can be integrated into needles allowing real-time cancer detection during endoscopy. Fluorescein is an imaging agent that can be used to visualize tissue. Using nCLE and fluorescein in combination with EBUS TBNA may be more effective in diagnosing lung cancer than using EBUS TBNA alone.
详细描述
PRIMARY OBJECTIVE:
I. To compare the first-pass diagnostic yield of the sequential needle passes (rapid on-site evaluation [ROSE]) between the robotic-nCLE-TBNA arm and the robotic-guided arm in peripheral pulmonary nodule (PPNs).
SECONDARY OBJECTIVES:
I. To compare the per-patient diagnostic yield (cumulative pass diagnostic yield: cumulative number of passes until five cumulated passes) of robotic-nCLE-guided TBNA to that of robotic-guided TBNA in PPNs.
II. To compare the proportion of patients with lung cancer treatment in the robotic-nCLE-guided TBNA arm to that of the robotic-guided TBNA arm in PPNs.
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
- Single (Outcomes Assessor)
盲法说明
Raters will be blinded to patient history and cytologic/pathologic diagnosis.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 21 years of age
- •Suspected PPN
- •Nodule size in computed tomography (CT) between 8 mm and 30 mm (largest dimension)
- •Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
排除标准
- •Inability or non-willingness to provide informed consent
- •Failure to comply with the study protocol
- •Patients with known allergy for fluorescein or risk factors for an allergic reaction
- •Use of beta-blocker within 24 hours before the start of the bronchoscopic procedure
- •Possibly pregnant, pregnant or breastfeeding women
- •Patients with hemodynamic instability
- •Patients with refractory hypoxemia
- •Patients with a therapeutic anticoagulant that cannot be held for an appropriate interval before the procedure
- •Patients who are unable to tolerate general anesthesia according to the anesthesiologist
- •Patient undergoing chemotherapy
- •INTRA-OPERATIVE EXCLUSION/STOPPING CRITERIA:
- •The lesions are unable to be localized/confirmed by bronchoscopy
- •The procedure will be terminated if the patient develops a significant procedural complication as determined by the treating physician
- •The procedure will be terminated if the patient develops hemodynamic instability as determined by the treating physician
结局指标
主要结局
First-pass Diagnostic Yield
时间窗: Baseline
Calculated as the proportion of patients for which first-pass transbronchial needle aspiration during bronchoscopic procedure yielded a definitive diagnosis out of the total number of patients that have received a diagnostic procedure.
次要结局
- Per-patient Diagnostic Yield(Baseline to 12 months following procedure)