NCT06937112招募中不适用
Clinical Application of a Novel 18F Labeled Fibroblast Activation Protein (FAP) Targeted Molecular Probe in Early Tumor Diagnosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- SUVmax of lesion uptake value
研究概览
简要总结
Evaluate the safety of the novel FAP targeted molecular probe 18F-FAPI-YQ104 labeled with radioactive isotopes in clinical applications and verify its effectiveness in tumor diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer for the trial, with the patient or their legal guardian signing the informed consent form;
- •Volunteers are not limited by gender, and the age range is from 18 to 75 years old, including both ends;
- •Other imaging examination methods (CT, MRI, etc.) revealed tumor occupying lesions;
- •Patients with lung cancer, thyroid cancer, pancreatic cancer, melanoma, and neuroendocrine tumors who can obtain the final pathological results.
- •Kidney: GFR > 50 ml/min, ERPF > 280 ml/min, platelet count (PLT) > 75,000/μL, white blood cell (WBC) > 3,000/μL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the normal value.
排除标准
- •Individuals with a history of allergies to similar drugs (drugs with similar chemical or biological components to FAPI), allergic constitution, or current allergic diseases;
- •Those who are currently conducting clinical research on other drugs or have participated in any clinical research on drugs (excluding vitamins and minerals);
- •There are other clinical problems that are difficult to control (such as HIV, hepatitis C virus infection or active hepatitis B, or other serious chronic infections and serious mental, neurological, cardiovascular, respiratory and other system diseases);
- •Red blood cell RBC<4 × 1012, white blood cell WBC<3 × 109, hemoglobin<110g/L, PLT<75000×109；
- •Significant abnormalities in liver and kidney function, with GFR less than 50 ml/min;
- •Tumor burden greater than 50%, or significant spinal cord compression;
- •Expected survival period is less than six months; Chemotherapy within June;
- •Having severe acute comorbidities or severe refractory mental disorders;
- •Pregnant and lactating women (where pregnancy is defined as a positive urine pregnancy study);
- •Patients whose physical condition is not suitable for radiation examination;
- •Other situations that researchers consider unsuitable for participating in the experiment.
结局指标
主要结局
SUVmax of lesion uptake value
时间窗: 60 minutes after administration
次要结局
未报告次要终点
研究者
Feng Wang
Chief physician
Nanjing First Hospital, Nanjing Medical University
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Clinical Study of 18F-FAPI-RGD in Interstitial Lung Disease Associated With Connective Tissue DiseaseInterstitial Lung DiseaseNCT06143540Sichuan Provincial People's Hospital30
招募中
不适用
99mTc Labeled FAP Targeted Molecular Probe in Early Diagnosis of TumorsHead and Neck TumorLung CancerPancreatic CancerNCT06438705Nanjing First Hospital, Nanjing Medical University20
招募中
不适用
[18F]AlF-NOTA-FAPI-04 PET/CT in Inflammation and Fibrosis in Renal Diseases18F-FAPI PET/CT ExaminationRenal Puncture BiopsyNCT05752097Sichuan Provincial People's Hospital30
已完成
不适用
Clinical Study of 18F-FAPI-RGD in Ovarian CancerObservationalNCT06614062Sichuan Provincial People's Hospital30
已完成
不适用
Clinical Study of 18F-FAPI-RGD in Breast TumorsBreast TumorsNCT05976620Sichuan Provincial People's Hospital30