A Study to Evaluate 68Ga-N188 PET/CT Imaging of Nectin-4 Expression in Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors
研究概览
简要总结
The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant imaging target for malignancies.
[68Ga]N188, a novel molecular probe of PET imaging agent that targets Nectin-4, can be used in the diagnosis and research of a wide variety of Nectin-4 high-expression malignancies, including bladder cancer.
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 —（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]N188
Subjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-N188 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]N188 (Drug)
结局指标
主要结局
The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors
时间窗: 1 year
Compare the number of lesions detected by 68Ga-N188 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.
次要结局
- The dosimetry of 68Ga-N188(1 year)
- Correlation with pathological expression(1 year)
- Quantitative evaluation of 68Ga-N188(1 year)
研究者
Jianhua ZHANG
Principal Investigator
Peking University First Hospital