Androgen Receptor and Estrogen Receptor Imaging in Metastatic Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Sensitivity/ specificity
研究概览
简要总结
Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in treatment-decision making. Patients with ER-positive tumors can be treated with anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy. Whole-body tumor ER-expression can be visualized by 18F-fluoroestradiol PET imaging (FES-PET). In addition to ER, the androgen receptor (AR) is a potential new target in breast cancer. PET imaging with 18F-fluorodihydrotestosterone (18F-FDHT) may allow visualization of tumor AR-expression. In the current study we will perform FES-PET and FDHT-PET in metastatic breast cancer patients and evaluate the concordance with concurrent biopsies. Molecular imaging of tumor AR- and ER-expression may well be of value for future treatment decision-making.
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
- •Metastatic breast cancer, with at least one known metastasis outside of the liver
- •Presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion)
- •Postmenopausal status defined as one of the following:
- •age ≥60 years
- •previous bilateral oophorectomy
- •age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
- •patients age <60 years using an ER-antagonist should have amenorrhea for > 12 months and FSH >24 U/L and LH >14 U/L e. patient age <60 years using LH-RH agonists should continue LH-RH-agonists until after the PET procedures
- •Initially ER-positive tumor histology.
- •ECOG performance status 0-
- •Signed written informed consent
- •Able to comply with the protocol
排除标准
- •Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study
- •Life-expectancy ≤ 3 months
结局指标
主要结局
Sensitivity/ specificity
时间窗: within two months
The concordance between PET (with 18F-FDHT and 18F-FES), and immunohistochemistry (for AR and ER) on concurrent (within 8 weeks) tumor biopsy will be evaluated.
次要结局
- Inter- and intra-patient variation(within six weeks)
- Accuracy(within six weeks)
- Inter-observer variation(approximately two months)