Feasibility Study: FES-PET to Determine ER-expression in Epithelial Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The feasibility of FES-PET to visualize and quantify ER-positive lesions in epithelial ovarian cancer.
研究概览
简要总结
Estrogens are implicated in the development of ovarian cancer and estrogen receptors (ER) alpha and beta are present in 20-100% of ovarian cancer patients. For this reason, antihormonal therapy with anti-estrogens or ER-antagonists is potentially an attractive treatment option. However, only a small proportion of patients (5-19%) will respond to antihormonal therapy. ER-expression in ER-positive breast cancer can be assessed by positron emission tomography (PET) with [18F]fluoroestradiol (FES). In this study the investigators will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian cancer. If these results are positive, this would warrant further exploration of FES-PET imaging in ovarian cancer.
详细描述
Investigators will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian cancer. If these results are positive, this would warrant further exploration of FES-PET imaging in ovarian cancer.
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
- Single (Investigator)
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
- •Histological evidence or high clinical suspicion of epithelial ovarian cancer
- •The presence of at least one measurable lesion (RECIST version 1.1).
- •Histology or cytology can be obtained (may be ascites)
- •Eastern Cooperative Oncology Group performance status 0-
- •Postmenopausal status (defined as either >45 years with amenorrhea >12 months, or prior bilateral ovariectomy)
- •No history of other ER-positive malignancies
- •Signed written informed consent
- •Able to comply with the protocol
排除标准
- •Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, during the 5 weeks before entry into the study
- •Life-expectancy ≤ 3 months
结局指标
主要结局
The feasibility of FES-PET to visualize and quantify ER-positive lesions in epithelial ovarian cancer.
时间窗: approximately 1 month
Ovarian cancer patients planned for surgery or in which histology/cytology will be obtained, will undergo FES-PET/CT. FES-PET/CT will be qualitatively analyzed to determine whether ovarian cancer lesions can be visualized. FES-uptake will be quantified for all known lesions. Patient material will be stained for ER-expression to determine whether ER-positive metastases show FES-uptake.
次要结局
- Correlation between FES-PET and immunohistochemistry (IHC)(approximately 1 month)
- Concordance between CT-scan and FES-PET(approximately 1 month)