[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE: Functional Precision Oncology for Metastatic Breast Cancer Feasibility Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of patients on the FORESEE trial refractory to all combinatorial hormonal therapies that are recruited and imaged with FES-PET/CT prior to switching to non-hormonal therapeutic agents
研究概览
简要总结
This protocol is a companion imaging study that will add FES-PET/CT imaging to the FORESEE trial at HCI. This study will establish the feasibility of using FES-PET/CT imaging to guide therapeutic decision making for functional precision oncology trials. The unique ability of FES-PET/CT to show absence of functional estrogen receptors throughout the entire body may improve confidence among research oncologists that an ER+ metastatic breast cancer patient is truly refractory to hormonal therapies which is a critical determination in the study design of the FORESEE trial.
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
- •Adults aged 18 years or greater.
- •All patients or legal guardians are willing and able to sign written informed consent and HIPAA authorization in accordance with local and institutional guidelines.
- •Enrolled on the FORESEE trial.
- •Biopsy proven estrogen receptor positive breast cancer.
- •Patient deemed refractory to all combinations of hormonal therapies by FORESEE trial investigators.
排除标准
- •Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
- •Patients who require monitored anesthesia for PET/CT scanning.
- •Patients who are too claustrophobic to undergo PET/CT scanning.
- •Patients who are pregnant or currently breast feeding.
- •Any patient that is medically unstable defined as a patient requiring inpatient hospitalization or needing evaluation at an acute care or urgent care facility at the time of imaging.
研究组 & 干预措施
Treatment: all patients
One session of [18F]FES PET/CT Imaging
干预措施: [18F]Fluoroestradiol (FES) PET/CT (Drug)
结局指标
主要结局
Number of patients on the FORESEE trial refractory to all combinatorial hormonal therapies that are recruited and imaged with FES-PET/CT prior to switching to non-hormonal therapeutic agents
时间窗: 12 weeks
establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials
次要结局
- Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy(12 weeks)
- Rate of concordance between positive FES-PET/CT scan and response to hormonal therapies from drug profiling results using patient-derived organoid models(12 weeks)