A RANDOMIZED TRIAL COMPARING PERCUTANEOUS ULTRASOUND-GUIDED NEEDLE ASPIRATION/BIOPSY WITH AND WITHOUT RAPID ON SITE EVALUATION IN PATIENTS WITH SUSPECTED SUPERFICIAL METASTASIS FROM LUNG CANCER
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Diagnostic yield for a tissue diagnosis
研究概览
简要总结
This is an investigator-initiated, single center, controlled, randomized clinical trial with two parallel arms in a 1:1 ratio. The objective of the study is to systematically assess the influence of rapid on-site evaluation (ROSE) on the diagnostic yield for diagnosis and molecular profiling, as well as on the safety, of pulmonologist-performed ultrasound-assisted needle aspiration biopsy (US-NAB) of superficial lesions across different metastatic sites in a series of consecutive patients with suspect locally advanced or advanced lung cancer.
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
- •Known/suspected lung cancer
- •Presence of a suspected "superficial" metastasis at imaging studies (CT and/or PET)
- •Indication to tissue sampling for diagnosis, staging and/or molecular profiling
- •18 years or older
- •Provision of a written informed consent
排除标准
- •Inability or unwillingness to consent
- •Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
- •Use of antiplatelet (excluded aspirin) or anticoagulant drugs that cannot be discontinued
研究组 & 干预措施
US NAB group
Ultrasound-assisted percutaneous needle aspiration without rapid on-site evaluation
ROSE group
Ultrasound-assisted percutaneous needle aspiration with rapid on-site evaluation
干预措施: Rapid on-site evaluation (Diagnostic Test)
结局指标
主要结局
Diagnostic yield for a tissue diagnosis
时间窗: 20 days
次要结局
- Diagnostic yield for PDL1 testing(30 days)
- Diagnostic yield for cancer genotyping(30 days)
- Complication rate(7 days)