To Compare the Clinical Application of 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG PET/CT in Tumor Diagnosis, Staging and Recurrence Detection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 120
- 主要终点
- To evaluate the sensitivity and specificity of 18F-LNC1007 (18F-FAPI-RGD) PET/CT at the patient level compared with 18F-FDG PET/CT;
研究概览
简要总结
To evaluate the safety of 18F-LNC1007 injection in the diagnosis of suspected tumor, initial stage, or recurrence monitoring; to explore the biological distribution of 18F-LNC1007 injection in patients; To compare the diagnostic efficacy of 18F-LNC1007 injection PET/CT versus 18F-FDG PET/CT imaging in patients with tumor with clinical suspicion, initial stage, or recurrence monitoring.
详细描述
This is a prospective, controlled, open-label (with blind members), single-center clinical trial to evaluate the diagnostic efficacy and safety of 18F-LNC1007 injection PET/CT for suspected tumor or tumor initial staging, recurrence monitoring, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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) Age ≥18 years old; (2) Clinically suspected or confirmed tumor patients; (3) As judged by doctors, the expected survival time is 3 months; (4) Voluntarily sign informed consent; (5) Willing and able to follow the research protocol; (6) The subject must be able to lie on the scanning bed for at least 1 hour.
排除标准
- •(1) known allergic history to 18F-LNC1007 injection; (2) Patients who cannot tolerate intravenous drug administration (such as needle fainting and blood fainting history); (3) Those who are not suitable for PET/CT and other imaging examinations or cannot complete them due to special reasons, including claustrophobia and radiophobia; (4) pregnant and lactating women; (5) Workers who are exposed to radiation for a long period of time; (6) serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis; (7) Participating in other interventional clinical trials within 1 month before screening; (8) Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy; (9) There are other circumstances that the researcher considers inappropriate to participate in this study.
研究组 & 干预措施
Compare 18F-LNC1007 injection (18F-FAPI-RGD) PET/CT and 18F-FDG PET/CT imaging
This is a prospective, controlled, open-label (with blind members), single-center clinical trial to evaluate the diagnostic efficacy and safety of 18F-LNC1007 injection PET/CT for suspected tumor or tumor initial staging, recurrence monitoring, etc.
干预措施: 18F-LNC1007（18F-FAPI-RGD） PET/CT 和 18F-FDG PET/CT (Other)
结局指标
主要结局
To evaluate the sensitivity and specificity of 18F-LNC1007 (18F-FAPI-RGD) PET/CT at the patient level compared with 18F-FDG PET/CT;
时间窗: 3 months
To evaluate the sensitivity and specificity of 18F-LNC1007 (18F-FAPI-RGD) PET/CT at the patient level compared with 18F-FDG PET/CT;
次要结局
- Compare the difference of the uptake of imaging agent between 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG injection in tumor lesions or metastases(3 months)
研究者
Jiang Wu
archiater
Jinling Hospital, China