Additive Value of EBUS TBNA for Staging Non-Small Cell Lung Cancer in Patients Evaluated for Stereotactic Body Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Lymphnode Staging Accuracy
研究概览
简要总结
This clinical trial studies how well endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) after positron emission tomography/computed tomography (PET/CT) scan works in diagnosing patients with stage I-IIA non-small cell lung cancer evaluated for stereotactic body radiation therapy (SBRT). Performing EBUS-TBNA after PET/CT scan may help doctors learn more about the accuracy and ways to find early stage lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To assess the use of EBUS-TBNA after a PET/CT as a means of improving the accuracy of lymph node staging in patients considered for SBRT.
SECONDARY OBJECTIVES:
I. To assess the usefulness of PET/CT as a diagnostic test in identifying N1 versus N0 staging.
II. To compare survival and recurrence rates in patients with discordant PET/CT and EBUS-TBNA.
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
- •Patient must be > 18 years old
- •Patient must have proven or suspected non small cell lung cancer (NSCLC) and be clinical Stage I or IIa, according to the 7th edition staging system of the American Joint Commission on Cancer for lung cancer (T1 or T2a, N0 or N1, M0)
- •Patient must have a PET/CT obtained within 40 days of having the EBUS-TBNA
- •Patient is being considered for SBRT
- •Patient or the patient's legally authorized representative must provide written informed consent prior to registration and any study-related procedures
- •If the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a) Patient has undergone potentially curative therapy for all prior malignancies b) No evidence of active / recurrent disease within 5 years
排除标准
- •Patient has received prior chemotherapy or radiotherapy for this cancer
- •Patients already scheduled to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression)
- •Patients malignancy is consistent with well differentiated neuroendocrine (carcinoid) histology
- •Patients who are planning to undergo treatment in a different institution
结局指标
主要结局
Lymphnode Staging Accuracy
时间窗: 1 day
The use of EBUS-TBNA after a PET/CT as a means of improving the accuracy of lymphnode staging in patients considered for SBRT estimated as the proportion of patients identified concordantly as having N0 disease with both PET/CT and EBUS-TBNA.
次要结局
未报告次要终点