Dynamic and Test-retest Whole Body [18F]FES PET Imaging in Patients With Metastatic ER+ Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- FES uptake in lesions: Ki (net influx rate) or VT (volume of distribution) values
研究概览
简要总结
16a-18F-fluoro-17b-estradiol ([18F]FES) is radioactive labeled estradiol, developed for in vivo visualization of the estrogen receptor (ER) using positron emission tomography (PET). To date, [18F]FES PET has been mainly explored as a diagnostic imaging tool to assess ER expression, thereby identifying locations of disease and their potential sensitivity to endocrine therapy, respectively. The primary aim of this project is to extend the application of [18F]FES PET as a baseline diagnostic imaging biomarker for ER expression to use it as an (early) treatment response marker. However, for such an application, visual assessment alone may not be sufficient and a more rigorous quantitative image analysis is needed. Therefore, in this project we shall first derive the optimal pharmacokinetic model for full quantitative analysis of [18F]FES uptake and, subsequently, we shall assess the validity of simplified, clinically feasible, quantitative parameters of [18F]FES uptake in 5 patients with metastatic estrogen receptor positive (ER+) breast cancer (part A). In addition, the repeatability of these simplified parameters will then be investigated in another 10 patients (part B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Histologically proven metastatic ER+ (>10% positive stained cells using immunohistochemistry) breast cancer on the latest biopsy
- •Postmenopausal females aged 18 years or older at screening. Postmenopausal status is defined as one of the following:
- •age ≥60 years
- •age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
- •patient age <60 years using LH-RH agonists should continue LH- RH-agonists until after the PET procedures
- •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 physician
- •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 this study
研究组 & 干预措施
Part A: dynamic FES PET imaging
All patients included in part A will receive a dynamic FES PET/CT scan.
干预措施: FES (Drug)
Part B: whole body static FES PET imaging
All patients included in part B will receive a whole body static FES PET/CT scan twice within 1 week.
干预措施: FES (Drug)
结局指标
主要结局
FES uptake in lesions: Ki (net influx rate) or VT (volume of distribution) values
时间窗: 1 year
FES uptake in lesions will be expressed as Ki or VT values
次要结局
- SUV and TBR values(1 year.)
研究者
C. Menke- van der Houven van Oordt
Principal investigator
Amsterdam UMC, location VUmc