Application of 68Ga-NODAGA-SNA006 in Patients With Solid Tumor or Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of 68Ga-NODAGA-SNA006-emergent Adverse Events
研究概览
简要总结
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in subjects with solid tumor or lymphoma.
详细描述
The aim of this study was to explore the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in patients with solid tumors or lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who were diagnosed with malignant tumors;
- •Patients are between 18 and 80 years of age are between 18 and 80 years of age.
排除标准
- •Participants who were unable or unwilling to provide written informed consent.
- •Participants who were unable to successfully complete the examination and are forced to abort the test in the middle of the test
研究组 & 干预措施
Feasibility and safety of 68Ga-NODAGA-SNA006
68Ga-NODAGA-SNA006 0.05 mCi/Kg, interval time between FDG was within five days
干预措施: 68Ga-NODAGA-SNA006 (Drug)
结局指标
主要结局
Incidence of 68Ga-NODAGA-SNA006-emergent Adverse Events
时间窗: 3 YEAR
Through PET/CT, Visual analysis was positive, or the SUVmax was more than the mediastinum
Biodistribution of 68Ga-NODAGA-SNA006
时间窗: 3 YEAR
Through PET/CT analysis, SUVmax and SUVmean of the organs
次要结局
- Correlation analysis of 68Ga-NODAGA-SNA006 uptake and tumor immune phenotype(3 YEAR)
研究者
Yuxuan Zhao
Clinical Professor
First Hospital of China Medical University