[18F]Fluoroestradiol (FES) PET/CT Imaging to Evaluate in Vivo ER in Endocrine Refractory Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Evaluate [18F]FES PET/CT Uptake
研究概览
简要总结
In this study, positron emission tomography (PET/CT) imaging will be used to evaluate estrogen receptor (ER) activity in sites of metastatic disease using the investigational radiotracer [18F]fluoroestradiol (FES).
详细描述
This study will evaluate [18F]FES PET/CT uptake as a predictor of progression free survival in endocrine refractory recurrent or metastatic breast cancer patients starting a new therapy regimen including endocrine targeted therapy. Imaging will occur prior to starting new therapy. Some patients may also undergo a second FES PET/CT scan at the time of suspected progression of disease to compare for changes in FES uptake measures. This is an observational study in that [18F]FES PET/CT will not be used to direct therapy decisions.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Recurrent or metastatic cancer that is of known or suspected breast origin - may be biopsy proven or identified on standard imaging (e.g. CT, bone scan, MRI, FDG PET/CT)
- •History of ER+ pathology (ER+ may be confirmed from surgery or biopsy of primary breast cancer or lymph nodes, and/or surgery or biopsy of a metastatic site, metastatic biopsy is not required)
- •At least one site of disease outside of the liver that is seen on standard imaging (e.g. CT, bone scan, MRI, FDG PET/CT); patients with measurable or nonmeasurable disease are allowed.
- •History of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening
- •Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures
排除标准
- •Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential.
- •Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- •Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- •History of HER2/neu positive cancer (IHC 3+ and/or FISH positive) as assessed by medical record review at screening
研究组 & 干预措施
FES PET/CT
All subjects will receive an [18F]FES PET/CT scan.
干预措施: [18F]FES (Drug)
结局指标
主要结局
Evaluate [18F]FES PET/CT Uptake
时间窗: 4 years
Evaluate \[18F\]FES PET/CT uptake as a predictor of progression free survival in endocrine refractory recurrent or metastatic breast cancer patients starting a new therapy regimen including endocrine targeted therapy
次要结局
- Compare FES Uptake Measures at Baseline and Progression(4 years)
- Correlate [18F]FES Uptake Measures with Standard Immunohistochemistry(4 years)
- Evaluate the utility of combined [18F]FES PET/CT and FDG PET/CT(4 years)
- Correlate FES uptake measures with number of ER+ Circulating Tumor Cells(4 years)
- Evaluate Overall Survival in Patients(4 years)