Diagnosis of Metastatic Tumors on 68Ga-FAPI-RGD PET-CT and Radioligand Therapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- tandarStandardized uptake value of 177Lu-TATE-RGD in normal organs and tumors.
研究概览
简要总结
FAP and RGD are overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-FAPI-RGD--a new dual-targeted 177Lu therapeutic drug for the first time in the world.
详细描述
Fibroblast activation protein (FAP) and RGD are serine peptidase on the surface of tumor associated fibroblasts. It has special biological characteristics and stable genome. They are usually not expressed or expressed at a low level in the resting tissues of normal adults, but it is highly expressed in diseases related to tissue repair and matrix reconstruction,Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors and used to 177Lu PRRT. We'll try to assess the safety and therapeutic response to 177Lu-FAPI-RGD in patients with metastatic tumors in human.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed treated or untreated metastatic tumors patients;
- •68Ga-FAPI PET/CT and 18F-FDG PET/CT within two weeks;
- •signed written consent.
排除标准
- •pregnancy;
- •breastfeeding;
- •any medical condition that in the opinion of the investigator may significantly interfere with study compliance
研究组 & 干预措施
68Ga-FAPI-RGD PET/CT for scan and 177Lu-FAPI-RGD for therapy
All patients diagnosed with metastatic tumors underwent 68Ga-FAPI-RGD PET/CT scan. If the PET/CT showed high FAPI expression in tumor lesions of some patients, they would intravenously injected with the dose about 2.22-3.33 GBq (60-100 mCi) of 177Lu-FAPI-RGD for therapy.
干预措施: 68Ga-FAPI-RGD for PET / CT scan and 177Lu-FAPI-RGD for therapy (Drug)
结局指标
主要结局
tandarStandardized uptake value of 177Lu-TATE-RGD in normal organs and tumors.
时间窗: through study completion, an average of half-year
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and tumors will be measured.
Adverse events collection
时间窗: through study completion, an average of 2 months
Adverse events within 2 months after the injection and scanning of patients will be followed and assessed.
次要结局
- SUVmax, SUVmean, lesion-based analysis(through study completion, an average of 1 year)
研究者
Zhaohui Zhu
Clinical Professor
Peking Union Medical College Hospital