A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Verify the subtype value of dual-PET in extrahepatic metastases
研究概览
简要总结
Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer
详细描述
A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects voluntarily joined the study, signed informed consent, and had good compliance.
- •Female patients aged over 18 years (including cutoff value).
- •an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Recurrence or metastatic breast cancer confirmed by histopathology, or expect to be feasible metastasis puncture or surgery to confirm histopathological recurrence or metastatic breast cancer.
排除标准
- •Pregnancy or lactation.
- •Alcohol allergy is not suitable for FES-PET/ C.
- •There are contraindications for patients who are expected to have metastasis puncture or surgery.
- •Mental disorders or other conditions affecting patient compliance.
研究组 & 干预措施
Metastatic breast cancer patients
50 metastatic breast cancer patients
干预措施: biopsy or surgical pathology in metastases (Procedure)
Metastatic breast cancer patients
50 metastatic breast cancer patients
干预措施: 68Ga-HER2 affibody,18F-FDG, 18F-FES (Drug)
结局指标
主要结局
Verify the subtype value of dual-PET in extrahepatic metastases
时间窗: 2 year
Verify whether the subtype value of FES-PET and HER2-PET is consistent with biopsy or surgical pathology in extrahepatic metastases.
次要结局
- Verify the HER2-PET value in brain metastasis(2 year)
- Verify the HER2-PET value in liver metastasis(2 year)
- Heterogeneity in metastatic lesions(2 year)
研究者
Xichun Hu
Director of department of medical oncology
Fudan University