NCT01956513撤回不适用
Etude ADC Apport de l'IRM Dans l'évaluation du Coefficient de Diffusion Apparent et prédiction de la réponse à la chimiothérapie néoadjuvante Dans le Cancer du Sein
Centre Jean Perrin0 个研究点开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Variation of apparent diffusion coefficient before / after a cycle of neoadjuvant chemotherapy or before / after modification of the treatment sequence and correlated with histologic response
研究概览
简要总结
The main objective of the study is to assess the sensitivity and the specificity of the variation of apparent diffusion coefficient for prediction, after a course of neoadjuvant chemotherapy or after modification of the treatment sequence, the pathological response at the end of chemotherapy
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years.
- •Patient suffering from a breast tumor, regardless of the stage and size
- •Patient requiring neoadjuvant chemotherapy
- •Patient has the ability to undergo 18F-FDG-PET at baseline, at end of cycle 1 and at the end of neoadjuvant treatment before surgery
- •Compulsory affiliation to a social security system.
- •Obtaining informed consent in writing, signed and dated.
排除标准
- •Patient with cognitive or psychiatric disorders.
- •Patient deprived of liberty by a court or administrative.
- •Patient with signs against the achievement of MRI, mammography and ultrasound
- •Patient metastatic
- •Patient with prior chemotherapy, radiotherapy and hormone therapy for her breast cancer
- •Pregnant women, current lactation
- •Patient suffering from uncontrolled diabetes (> 11 mmol / L)
结局指标
主要结局
Variation of apparent diffusion coefficient before / after a cycle of neoadjuvant chemotherapy or before / after modification of the treatment sequence and correlated with histologic response
时间窗: One year
次要结局
未报告次要终点
研究者
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