Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass: a Diagnostic Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- specificity of dielectric property test in diagnosing lung nodules/masses
研究概览
简要总结
Patients with lung nodules/mass found by CT (computed tomography) or PET (positron emission tomography) who agree to receive lung resection are arranged to test the dielectric property before receiving the frozen pathological examination. And the final pathological results are recognized as the standard diagnosis. Then the sensitivity and specificity of the dielectric property test will be evaluated comparing with the frozen pathological examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with lung nodules/mass found by CT or PET who agree to receive lung resection;
- •Diameter of the lung nodule/mass is longer than 8 millimeters;
- •More than 50% of the lung nodule/mass is solid component by image examination;
- •Diameter of the solid component is longer than 5 millimeters by intraoperative exploration.
排除标准
- •Cutting open the resected nodule/mass will interfered with the pathological examination;
- •Diameter of the solid component is shorter than 5 millimeters by intraoperative cutting open;
- •Cutting open the lung nodule/mass will cause great damage to the patient, such as inducing allergic shock.
研究组 & 干预措施
dielectric property test
The patient with lung nodules/mass is firstly arranged to be tested for dielectric property after the nodules/mass resection and cutting open.
干预措施: dielectric property test (Diagnostic Test)
frozen pathological examination
The resected lung nodules/mass will be sent for frozen pathological examination after dielectric property test.
干预措施: frozen pathological examination (Diagnostic Test)
final pathological examination
The resected lung nodules/mass will undergo the final pathological examination for final diagnosis after dielectric property test and frozen pathological examination.
干预措施: final pathological examination (Diagnostic Test)
结局指标
主要结局
specificity of dielectric property test in diagnosing lung nodules/masses
时间窗: 3-5 years
true negative rate in diagnosing lung nodules/masses
sensitivity of dielectric property test in diagnosing lung nodules/masses
时间窗: 3-5 years
true positive rate in diagnosing lung nodules/masses
次要结局
未报告次要终点