Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Treatment in Patients With Mammary Gland Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 275
- 试验地点
- 2
- 主要终点
- difference of Δ SUV (Standardised Uptak Value) between 18F-FDG PET 1 and 18F-FDG PET2 to predict pCR during neoadjuvant chemotherapy
研究概览
简要总结
Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The rate of pCR is about 20%, although there are important variations according to tumor subtype and the type of treatment. The objective of the new therapeutic strategies is to increase this response rate.
The purpose of this study is to investigate the possibility of early evaluation of neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.
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
- •patient having been informed of the study
- •patient affiliated to a social health insurance
- •≥ 18 years
- •patient presenting a breast cancer histologically confirmed
- •indication of neoadjuvant chemotherapy treatment (classification UICC: II or III)
- •patient agrees with exploitation of his clinical, biological and image data
排除标准
- •distant metastasis
- •contraindications to chemotherapy
- •contraindications to surgery
- •serious illness not balanced, subjacent infection
- •pregnancy or breast feeding
- •diabetes not controlled (glycemia> 8 mmol/L)
- •psychiatric disease
- •patient under supervision, trusteeship or safeguard of justice
结局指标
主要结局
difference of Δ SUV (Standardised Uptak Value) between 18F-FDG PET 1 and 18F-FDG PET2 to predict pCR during neoadjuvant chemotherapy
时间窗: early metabolic response mesure by 18F-FDG PET (difference of Δ SUV) at 3 weeks after neoadjuvant chemotherapy to predict pathologic Complete Response (pCR) by exploiting PET data realized before treatment (PET1) and after a cure of chemothrapy (PET2)
次要结局
- Δ SUV (Standardised Uptak Value) threshold at 3 weeks(Δ SUV threshold at 3 weeks allowing to show the absence of response to treatment)
- Progression free survival(relation between early metabolic response (difference of Δ SUV ) assessed by 18F-FDG PET at 3 weeks and Progression-free survival)
- modification of tumor perfusion by 18F-FDG PET(modifications of tumor perfusion befoire and after one cycle(3 weeks) neoadjuvant chemotherapy by exploiting PET/PDG data (PET1 and PET2))