PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy
研究概览
简要总结
Predict and follow thanks to imaging the response to neoadjuvant chemotherapy in locally advanced breast carcinoma. Hypothesis : FLT-(18F)PET will be a predictor superior to both FDG-(18F) PET and MRI
详细描述
PET/CT with FDG-(18F) and FLT-(18F) and MRI are performed at the initial staging, 3 times during sequential adjuvant chemotherapy and prior to surgery, aiming to find the most efficient modality to predict the response to neoadjuvant chemotherapy of the primary breast cancer and its possible lymph node metastases. Post-surgical histology and a 6 month follow-up (to detect occult metastases) will constitute the standard of truth for determination and comparison of diagnostic performances.
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
- •Breast cancer scheduled for neoadjuvant chemotherapy followed by surgery
- •Exclusion criteria:
- •Indicated chemotherapy without that a curative tumorectomies is foreseen(planned)
- •Patient presenting an evolutionary infectious or inflammatory pathology, including an inflammatory breast cancer, being able to be source(spring) of false-positive results(profits) in TEP-FDG
- •Patient in the course of radiotherapy or of chemotherapy or operated at the level of the thorax in 4 weeks preceding the date foreseen(planned) by the examination TEP (pose(installation) of implantable room(chamber) excludes)
- •Diabetic waits
- •Patient already includes in the other protocols of search(research) for Nuclear Medicine or for imaging using ionization radiations
- •Patient not having given her lit(enlightened) assent
- •Wait among which the surveillance TEP or the MRI during the chemotherapy will be impossible (that is by geographical or professional imperative, or if contraindication in the MRI, ex: port(bearing) of a pacemaker, cochlear magnetic implants, metal foreign bodies cf protocol)
- •Of less than 18 years old or pregnant patient.
- •Breast cancer stage(stadium) IV
- •Biopsy on the already realized mammary tumor, for the period(delay) lower than 15 j.
- •In case of alcoholic poisoning or of antecedents of reaction to the injection of ethanol: not inclusion to be discussed.
排除标准
- 未提供
研究组 & 干预措施
1
Fluoro-L-thymidine-(18F)
干预措施: Fluoro-L-thymidine-(18F) (Drug)
结局指标
主要结局
Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy
时间窗: during de study
Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy
次要结局
未报告次要终点