A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors
研究概览
简要总结
Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.
[68Ga]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.
详细描述
Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.[68Ga]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with confirmed or suspected cancer; 18F-FDG PET/CT within 1 week; Signed written informed consent
排除标准
- •Pregnant and lactating women; Female patients plan to become pregnant within 6 months.
研究组 & 干预措施
[68Ga]P3
Subjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-P3 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.
干预措施: [68Ga]P3 (Drug)
结局指标
主要结局
The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors
时间窗: 1 year
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-P3 and 18F-FDG PET/CT
The detection efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors
时间窗: 1 year
Compare the number of lesions detected by 68Ga-P3 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.
次要结局
- The dosimetry of 68Ga-P3(1 year)
- Correlation with pathological expression(1 year)
- Quantitative evaluation of 68Ga-P3(1 year)
研究者
Xing YANG
Principal Investigator
Peking University First Hospital