A Study to Evaluate 68Ga-Her2-affibody PET/CT Imaging of Her2 Expression in Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer
研究概览
简要总结
This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.
详细描述
This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2 in whole body cancer lesions, aiming to provide a new imaging method for the determination of HER2 status in breast cancer and supplement more overall information that is difficult to obtain by traditional core needle biopsy. At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.
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
- 否
入选标准
- •patients with confirmed or suspected cancer; Signed written informed consent
排除标准
- 未提供
研究组 & 干预措施
68Ga-Her2-affibody
Subjects with suspected or confirmed breast cancer will receive an intravenous injection of 68Ga-Her2-affibody followed by PET imaging.
干预措施: 68Ga-Her2-affibody (Drug)
结局指标
主要结局
The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer
时间窗: 1 year
the standardized Uptake Value (SUV) of lesions on 68Ga-Her2-affibody PET/CT
次要结局
- Quantitative evaluation of 68Ga-Her2-affibody(1 year)
- Correlation with pathological expression(1 year)
- The dosimetry of 68Ga-Her2-affibody(1 year)
研究者
Lei YIN
Principal Investigator
Peking University First Hospital