Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ABH2 SPECT/CT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- SPECT/CT-based 99mTc-ABH2 uptake value in tumor lesions
研究概览
简要总结
This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.
详细描述
This study aims to assess the diagnostic performance of 99mTc-ABH2 SPECT/CT for the detection of HER2-positive primary breast cancer and possible metastases. Visual and semiquantitative methods will be utilized to evaluate the acquired SPECT/CT images. A comparative analysis of tumor imaging data and HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples will further be conducted. Results of HER2 expression imaging may have potential significance in screening and monitoring individuals for targeted therapy with monoclonal antibodies, like Trastuzumab.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •clinically suspected primary breast cancer by mammography or ultrasonography and being able to sign the written informed consent form
排除标准
- •pregnancy or lactation, impaired liver or kidney failure, and undergoing any preceding local or systemic therapies that might interfere HER2 binding
研究组 & 干预措施
99mTc-ABH2 SPECT/CT
The patients will be injected with 5.55 to 7.4 MBq per kilogram body weight of 99mTc-ABH2 in one dose intravenously and undergo SPECT/CT scan 1h to 2h later.
干预措施: 99mTc-ABH2 (Drug)
结局指标
主要结局
SPECT/CT-based 99mTc-ABH2 uptake value in tumor lesions
时间窗: 1 year
Uptake of 99mTc-ABH2 in the lesions will be assessed using SPECT/CT and measured in standardized uptake value (SUV).
次要结局
未报告次要终点