Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
Investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.
详细描述
At present, low-dose scanning protocol is widely used in computed tomography-guided interventions because these procedures usually require repeat scans, which causes more radiation exposure to the patients. Computed tomography-guided core needle biopsy is widely used in diagnosis of lung nodules with an overall diagnostic accuracy of 93%-97%. Compared with the large lung lesions, computed tomography-guided core needle biopsy for lung nodules might require more scanning to adjust the position of needle tip. Therefore, it might expose the patients to more radiation. However, studies regarding computed tomography-guided core needle biopsy for lung nodules are still lacking.
In this study, investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-diagnostic lung lesions (no definitive pathological diagnosis);
- •Lesion size between 5 and 30 mm;
- •Solid lung lesions.
排除标准
- •The lesion which has been punctured previously;
- •A lesion that had shrunk in size or a lesion with a stable size for 1 year;
- •Severe dysfunction in heart, lung and coagulation function;
- •Patients who refused to provide informed consent.
结局指标
主要结局
Diagnostic accuracy
时间窗: From the date of randomization until the date of first documented final diagnosis, assessed up to 12 months
Diagnostic accuracy is defined as the biopsy diagnosis matches with the final diagnosis. The final diagnosis is made according to the surgical or follow-up findings.
次要结局
- Radiation dose(From the date of randomization until the date of first documented biopsy procedures, assessed up to 1 day.)