PET / CT Imaging and Safety of the 68Ga-NOTA-RP25 Molecular Probe in Patients With Lymphoma Who Have Received Prior Therapy Containing CD19 CAR-T Cells
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- SUV value of radioactive material uptake in the region of interest
研究概览
简要总结
The proliferation and distribution of CD19 CAR-T cells in lymphoma patients are investigated 68Ga-NOTA-RP25 by PET / CT imaging.
详细描述
The purpose of this study is to monitor the proliferation and distribution of CD19 CAR-T cells in lymphoma patients by using a novel specific PET tracer 68Ga-NOTA-RP25 for monitoring the proliferation of CAR-T cells.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. The subjects voluntarily signed the informed consent form and were able to complete the test according to the protocol requirements;
- •Over 18 years old, male or female;
- •Diagnosed as lymphoma and intended to receive CD19 car-t treatment;
- •ECOG score is 0-1; The estimated survival time shall not be less than 3 months;
排除标准
- •1. Participate in other clinical trials other than CAR-T treatment at the same time or within 28 days. If participating in a non intervention clinical trial, it can be included in this study;
- •Patients with a history of allergy;
- •Patients who cannot tolerant PET / CT imaging；
- •Patients who are using anticoagulant drugs or need to use anticoagulant drugs during the study;
研究组 & 干预措施
68Ga-NOTA-RP25
Intravenous injection
干预措施: 68Ga-NOTA-RP25 (Diagnostic Test)
结局指标
主要结局
SUV value of radioactive material uptake in the region of interest
时间窗: 1 month
According to the PET / CT imaging results of 68Ga-NOTA-RP25 after iterative reconstruction, PMOD software is used to outline the tumor, brain, liver, heart, tumor and other tissues as regions of interest (ROI)
次要结局
- Safety evaluation index(1 month)
研究者
Miao Liyan
Chief Pharmacist
The First Affiliated Hospital of Soochow University