The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer: a Prospective, Observationa Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Predictive performance 1
研究概览
简要总结
Neoadjuvant immunotherapy can significantly improve the pathological complete response (pCR) and major pathological response (MPR) rates in resectable stage III non-small cell lung cancer (NSCLC), and extend the event-free survival (EFS). However, the current means for evaluating its efficacy are limited. This study aims to utilize the convenient and non-invasive 68Ga-grazytracer PET imaging to detect the aggregation of CD8+ T cells in target lesions after neoadjuvant immunotherapy for stage III NSCLC, and to assess its value in efficacy monitoring, providing valuable information for clinical treatment decisions.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage III NSCLC, after assessment according to clinical guidelines, require neoadjuvant immunotherapy;
- •Fully-informed written consent obtained from patients;
- •Patient ability to comply with protocol requirements;
- •Age 18-75 years;
- •Life expectancy of at least 6 months.
排除标准
- •Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;
- •Intestinal perforation, complete intestinal obstruction;
- •Patients with uncontrolled diabetes mellitus or a fasting blood glucose value of ≥11 mmol/L on the day of the test;
- •Pregnant women and women who are potentially pregnant, as well as nursing mothers;
- •Patients with poor compliance.
结局指标
主要结局
Predictive performance 1
时间窗: up to the end of surgery
Sensitivity and specificity of 68Ga-grazytracer PET in predicting pathological response.
次要结局
- Predictive performance 2(3 years)