16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Response rate six months after induction or major change in hormone therapy for metastatic breast cancer.
研究概览
简要总结
Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.
详细描述
Main objective: Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline.
Secondary objectives:
- evaluate diagnostic performance of FES PET/CT
- determine whether FES PET/CT is able to detect metastases that are not visible on FDG PET/CT. This point may constitute a direct benefit for the patient
- precise the nature of discordant FES/FDG foci
- validate and improve the interpretation criteria for FES PET/CT
- confirm the perfect tolerance
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Post menopausal
- •age > 17
- •Metastatic adenocarcinoma of the breast
- •Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment
- •Life expectancy > 6 months
- •Hormone-dependent cancer initially demonstrated by hormone receptors in the tumour
- •Presence of oestrogen receptors proven with immunohistochemistry (> 10%) and HER2 determined by immunohistochemistry or FISH (on primary tumour or a metastasis)
- •Metastatic recurrence on FDG PET dating less than 1 month, confirmed by another modality (contrast-enhanced CT, MRI, ultrasonography, bone scintigraphy or PET/CT, other)
- •FDG PET/CT available on PACS or CD DICOM III format 11
- •Informed consent obtained
排除标准
- •Other evolutive malignant disease or acute or chronic infectious disease
- •Chemotherapy during the last 3 months or change in treatment since FDG PET/CT.
- •Isolated liver metastasis (high FES uptake by normal liver)
研究组 & 干预措施
Fluoroestradiol (18F)
干预措施: Fluoroestradiol (18F) (Drug)
结局指标
主要结局
Response rate six months after induction or major change in hormone therapy for metastatic breast cancer.
时间窗: at 6 months
Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. Response will be determined according to RECIST 1.1 criteria for each patient.
次要结局
- Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers.(at 6 months)