18F-Fluoroestradiol (FES) Positron Emission Tomography for the Detection and Treatment Response Monitoring in Patients With Metastatic Lobular Breast Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7
- 试验地点
- 14
- 主要终点
- Comparison of FES PET/CT in Metastatic Invasive Lobular Carcinoma/ILC to standard-of-care (SOC) imaging with FDG PET/CT at baseline
研究概览
简要总结
The purpose of this study to compare two types of cancer imaging scans to see which is better at detecting and monitoring metastatic ILC. This study will compare PET/CT (positron emission tomography/computed tomography) scans using the radiotracer fluorine 18 (18F)-fluoroestradiol (FES) with a standard imaging approach for detecting and monitoring ILC, PET/CT scans using the radiotracer 18F-fluorodeoxyglucose (FDG). These scans will be referred to as FES PET/CT scans and FDG PET/CT scans.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patient > 18 years old
- •Biopsy-proven metastatic ILC
- •Confirmed ER+ breast cancer from either primary tumor or metastatic biopsy (ER receptor percent staining ≥ 10% of tumor cells by IHC)
- •HER2-negative per ASCO/CAP
- •ECOG Performance Status Score of 0, 1 or
- •Patient can have received up to 2 lines of therapy in the metastatic setting
- •Life expectancy of at least 12 months
排除标准
- •Low ER expression defined as ER <10% of tumor cells by IHC
- •Patients who have been on adjuvant ER-blocking endocrine therapy with SERM or SERD without an 8- and 24-weeks washout, respectively. (The use of aromatase inhibitors or ovarian suppression is permitted given that they do not block estrogen receptors).
- •Pregnancy or lactation or parturient or nursing mother
- •Patient presents with any other clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who has a life expectancy of <12 months, or for whom study participation may compromise their management; and/or a patient who the investigator judges to be unsuitable for participation in the study for any reason.
研究组 & 干预措施
Biopsy-proven ER+ Metastatic Invasive Lobular Carcinoma/ILC
Participants will have biopsy-proven metastatic ILC, confirmed ER+ breast cancer
干预措施: 18F-Fluoroestradiol PET/CT (Diagnostic Test)
结局指标
主要结局
Comparison of FES PET/CT in Metastatic Invasive Lobular Carcinoma/ILC to standard-of-care (SOC) imaging with FDG PET/CT at baseline
时间窗: 1 year
Disease detection by 18F-FES and 18F-FDG PET/CT images at baseline will be directly compared
次要结局
未报告次要终点