Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Diagnostic value
研究概览
简要总结
68Ga-PSMA-CYC is a novel radiotracer targeting PSMA. In this study, we investigated the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.
详细描述
Prostate cancer (PCa) is one of the most common malignant tumors among men worldwide. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein that is highly expressed in PCa and its metastatic lesions, making it an ideal target for the precise diagnosis and treatment of PCa. Various low-molecular-weight radiopharmaceuticals targeting PSMA have been developed, such as PSMA-11 and PSMA-617, which can be labeled with 68Ga or 177Lu. 68Ga-PSMA-CYC is a novel radiotracer that has demonstrated favorable in vivo and in vitro stability in preliminary studies, with specific accumulation in PCa, high binding affinity, and good safety profile, making it a promising candidate for further investigation. This prospective study aims to investigate the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •confirmed treated or untreated prostate cancer patients;
- •signed written consent.
排除标准
- •known allergy against PSMA;
- •any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
研究组 & 干预措施
Patients will undergo a 68Ga-PSMA-CYC PET/CT 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT
Prostate Patients received 68Ga-PSMA-CYC 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT imaging within one week. Tracer doses of 68Ga-PSMA-CYC、68Ga-PSMA-617 or 68Ga-PSMA-11 will be used to image lesions of prostate cancer by PET/CT
干预措施: 68Ga-PSMA-CYC (Drug)
68Ga-PSMA-CYC
Experimental: dynamic PET scans PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection
干预措施: CYC (Drug)
结局指标
主要结局
Diagnostic value
时间窗: through study completion, an average of 1year
Sensitivity and Specificity of 68Ga-PSMA-CYC for prostate cancer in comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 PET/CT.
Adverse events
时间窗: Within 7 days following PET/CT
The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
次要结局
- Dosimetry data(through study completion, an average of 3 months)