18F-grazy-02 PET/CT of Granzyme B Expression for Monitoring Immunotherapy in Patients With Lymphoma or Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of 18F-grazy-02-emergent Adverse Events
研究概览
简要总结
This is an open-label PET/CT study to investigate the safety and clinical monitoring value of 18F-grazy-02 in patients with lymphoma or solid tumors receiving immunotherapy, including immune checkpoint inhibition and CAR-T cell therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
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
- 是
入选标准
- •18-75 years old;
- •ECOG score 0 or 1 point;
- •Participants with suspected or confirmed non-small cell lung cancer or melanoma who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.
排除标准
- •Pregnant or nursing;
- •Severe hepatic or renal dysfunction;
- •Low WBC (less than 3 x 10^9/L);
- •Unable to comply with the PET/CT imaging procedures.
研究组 & 干预措施
experimental 18F-grazy-02 PET/CT imaging
The purpose of the study is to evaluate the safety and early monitoring performance of 18F-grazy-02 for immunotherapy.
干预措施: 18F-grazy-02 (Drug)
结局指标
主要结局
Incidence of 18F-grazy-02-emergent Adverse Events
时间窗: 1 year
Any adverse events following the administration of the radiotracer will be monitored.
Biodistribution of 18F-grazy-02 in participants
时间窗: 1 year
The distribution of 18F-grazy-02 in tumors and healthy tissues will be examined through PET/CT imaging.
次要结局
- Assessing 18F-grazy-02 PET for monitoring immunotherapy responses(3 years)
研究者
Nan Li
Study Director
Peking University Cancer Hospital & Institute