Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time course of uptake on FAPI-PET
研究概览
简要总结
PET / CT examination using [18F] FAPI-74 is performed on patients diagnosed with malignant tumor, and the pathological condition is determined by comparing with FDG-PET/CT examination of conventional diagnostic imaging.
详细描述
Cancer stroma accounts for more than 90% of all tumors, and cancer-related fibroblasts (CAFs) play an important role in the growth and progression of cancer. FAP expressed in CAF has been found to be expressed in many cancers, and [68Ga] FAPI-04 and [18F] FAPI-74, which are PET diagnostic agents for FAP ligand FAPI, have been used all over the world. The purpose of this study is to perform PET / CT using [18F] FAPI-74 injection for patients diagnosed with malignant tumors, mainly pancreatic cancer and gastric cancer to evaluate the pathology in detail by comparing with the FDG-PET/CT.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet any of the following conditions.
- •Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination.
- •Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy.
- •Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor
排除标准
- •Pregnant women or patients who may be pregnant
- •Pediatric patients requiring sedation
- •Those who are judged to be inappropriate as subjects.
研究组 & 干预措施
FAPI-PET/CT group
干预措施: PET/CT ([F-18]FAPI-74) (Drug)
结局指标
主要结局
Time course of uptake on FAPI-PET
时间窗: Approximately 6 months after initial FAPI-PET
Time course of uptake on FAPI-PET before and after treatment compared with conventional imaging
Comparison of the uptake on FAPI-PET with conventional imaging
时间窗: Within 2 hours after administration of [F-18]FAPI-74 injection
Comparison of SUV (standardized uptake value) of primary site and metastatic lesions between FAPI-PET and FDG-PET
Comparison with pathological specimens
时间窗: Within one month after FAPI-PET
Comparison of expression level (staining score) in FAP immunostaining and SUV in FAPI-PET (FAP staining is graded by scoring evaluation: high expression (3 points), moderate expression (2 points), mild expression (1 point), and no significant expression (0 point).)
次要结局
未报告次要终点
研究者
Tadashi Watabe
Assistant Professor
Osaka University