NL-OMON50865招募中不适用
Dynamic and test-retest whole body [18F]FES PET imaging in patients with metastatic ER+ breast cancer. - FEStastic.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histologically proven metastatic ER+ (>10% positive stained cells
- •usingimmunohistochemistry) breast cancer on the latest biopsy
- •- Postmenopausal females aged 18 years or older at screening. Postmenopausal
- •status is defined as one of the following:
- •a. age >=60 years
- •b. age <60 years and amenorrhea for >12 months in the
- •absence of interfering
- •hormonal therapies (such as LH-RH agonists and
- •ER-antagonists)
- •c. patient age <60 years using LH-RH agonists should
- •continue LH-RH-agonists
- •until after the PET procedures
- •d. previous bilateral oophorectomy or medically confirmed
- •ovarian failure
- •- [18F]FDG PET, CT and/or a bone scan should be performed as part of routine
- •clinical staging (<=4 weeks prior to screening)
- •- Patients should have metastases in the scanning field of view, all located
- •outside of the liver
- •- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
- •- Estimated glomerular filtration rate (eGFR) >=30 ml/min
- •- Written and signed informed consent
排除标准
- •- History with another cancer within the last 5 years, except cancer treated
- •with curative intent and no evidence of disease as judged by the treating
- •- Use of selective estrogen receptor modulators (SERMs) or downregulators
- •(SERDs) for current breast cancer such as Tamoxifen/Fulvestrant (<=5
- •weeks prior to screening) or investigational drug therapy
- •- Pregnancy or lactating women
- •- Any medical, psychological or social condition that may interfere with the
- •subject*s safety and participation in the study, will lead to exclusion from
研究者
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