Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy
研究概览
简要总结
18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.
We propose to conduct a prospective study to evaluate early therapeutic response using 18F-FDG PET before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer patients.
Variation of 18F-FDG PET uptake is compared to clinical and echographical tumor response evaluated after 3 cycles of chemotherapy.
The purpose is to estimate the capacity of 18F-FDG PET to differentiate responder and non-responder patients.
详细描述
Further study details as provided by Centre Oscar Lambret
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Breast cancer treated by neo-adjuvant chemotherapy (T>2cm)
- •Measurable lesions ,assessed clinically and by ultrasound
- •Delay minimum between biopsy and PET: 15 days
- •PS-WHO: 0
排除标准
- •Inflammatory breast cancer (T4d)
- •Diabetic patients unbalanced (glycemia>1.40)
- •Pregnant or lactating women
研究组 & 干预措施
1
干预措施: FDG-PET (Other)
结局指标
主要结局
Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy
时间窗: before and 3 weeks after 1st cycle
次要结局
- Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy(3 weeks after the 3rd cycle)