A Prospective Study of the Predictive and Prognostic Value of Multimodalitic Imaging in the N-stage of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The diagnostic efficacy of18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA in the lymph node staging of NSCLC
研究概览
简要总结
This study aims to evaluate the diagnostic efficacy and differences between 18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA, 18F-FDG PET/CT combined with EBUS-TBNA, and MR STIR sequences combined with EBUS-TBNA - three types of multimodal imaging for assessing NSCLC N-stage, in order to select the best assessment protocol to guide treatment decisions and prognostic assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Biopsy pathologically confirmed NSCLC, or clinically highly suspicious NSCLC (assessed as highly suspicious by the MDT team of this study);
- •N1, N2, or N3 confined to the mediastinum and hilum, as assessed by imaging;
- •Proposed systematic lymph node dissection without any treatment;
- •Appropriate laboratory tests (serum tumor markers);
- •All examination intervals ≤ 4 weeks;
- •KPS score ≥ 50 (ECOG/WHO equivalent);
- •Aged > 18 years;
- •Patients can fully understand and voluntarily participate in this trial and sign the informed consent; the examination can be completed independently.
排除标准
- •Contraindication to EBUS-TBNA operation;
- •Presence or history of other malignancies within 10 years;
- •Inability to understand the examination procedure or to cooperate.
研究组 & 干预措施
PET/CT+MR+EBUS
Subjects will receive 18F-FDG PET/CT and MR STIR sequence combined with EBUS-TBNA, to diagnose the N-stage of NSCLC
干预措施: 18F-FDG (Drug)
PET/CT+MR+EBUS
Subjects will receive 18F-FDG PET/CT and MR STIR sequence combined with EBUS-TBNA, to diagnose the N-stage of NSCLC
干预措施: MR STIR (Device)
PET/CT+MR+EBUS
Subjects will receive 18F-FDG PET/CT and MR STIR sequence combined with EBUS-TBNA, to diagnose the N-stage of NSCLC
干预措施: EBUS-TBNA (Procedure)
PET/CT+EBUS
Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC
干预措施: 18F-FDG (Drug)
PET/CT+EBUS
Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC
干预措施: EBUS-TBNA (Procedure)
MR+EBUS
Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC
干预措施: MR STIR (Device)
MR+EBUS
Subjects will receive 18F-FDG PET/CT and EBUS-TBNA, to diagnose the N-stage of NSCLC
干预措施: EBUS-TBNA (Procedure)
结局指标
主要结局
The diagnostic efficacy of18F-FDG PET/CT and MR STIR sequences combined with EBUS-TBNA in the lymph node staging of NSCLC
时间窗: 1 year
Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of three multimodal methods for diagnosing mediastinal lymph node staging in NSCLC based on patients.
次要结局
- The diagnostic efficacy of18F-FDG PET/CT combined with MR STIR in the lymph node staging of NSCLC(1 year)
- The diagnostic efficacy of18F-FDG PET/CT combined with EBUS-TBNA in the lymph node staging of NSCLC(1 year)