68Ga-grazytracer PET/CT Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer: a Prospective, Observational Study.
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
- Diagnostic performance 1
研究概览
简要总结
Currently, there are limited methods available in clinical practice to distinguish pseudoprogression after immunotherapy. Most patients rely on follow-up observations to monitor the disease, which does not meet clinical needs. 68Ga-grazytracer is a novel imaging agent targeting granzyme B. By detecting the concentration of granzyme B, it reflects the localization of cytotoxic T cells in the tumor region and their potential ability to kill tumor cells. This study aims to leverage the simplicity, non-invasiveness, visualization, and semi-quantitative advantages of 68Ga-grazytracer PET imaging to evaluate its effectiveness and feasibility in diagnosing pseudoprogression.
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
- •Lung cancer patients who develope lesion enlargement and/or new lesions after treatment with immune checkpoint inhibitors;
- •Pseudoprogression cannot be ruled out in clinical practice;
- •Lung cancer confirmed by pathology or cytology, regardless of pathological type;
- •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;
- •Active phase of hepatitis B；
- •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
Diagnostic performance 1
时间窗: Follow-up for 4-8 weeks, not exceeding 12 weeks.
Sensitivity and specificity of 68Ga-grazytracer PET in diagnosing pseudoprogression
次要结局
- Diagnostic performance 2(Follow-up for 4-8 weeks, not exceeding 12 weeks.)