Usefulness of Angiomammography for Predicting the Response to Neoadjuvant Chemotherapy in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients with a pCR accoreding to angiomammography, based on a 50% reduction in lesion size at angiomammography
研究概览
简要总结
The best prognostic factor following neoadjuvant chemotherapy is the pathological complete response (pCR). pCR is defined as the absence of invading cells in the breast and lymph nodes following neoadjuvant chemotherapy treatment. Since patients with pCR have a better prognosis than those without pCR, some studies have evaluated different methods to predict pCR early in treatment. Thus, patients who do not respond optimally to treatment could be identified early and changed treatment in order to maximize the chances of pCR and avoid the morbidity of poorly effective treatments. To do this, several modalities have been proposed, including MRI, mammography, ultrasound, positron emission tomography, elastography, and serial biopsies, but these techniques have shown predictive and sometimes expensive. Nevertheless, assessment of tumor response after cycle 2 has been suggested to be appropriate for the prediction of pCR.
The main objective of this study is to compare the performance of two diagnostic modalities, namely CESM and MRI, in the evaluation of the response of a malignant breast tumor to neoadjuvant chemotherapy and the prediction of pCR. The radiological response will also be compared to the clinical response.
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
- •Female aged 18 and over
- •Histologically proven breast cancer by large gauge needle
- •No evidence of distant metastasis
- •Neoadjuvant chemotherapy with or without concomitant targeted therapy
- •Breast tumor initially measurable by clinical examination
排除标准
- •Refusal to perform the biopsy or surgery
- •Pregnant or possibly pregnant woman
- •Usual contraindication to contrast product
- •Significant kidney failure
- •Allergy to contrast medium
- •frank hyperthyroidism
- •Usual contraindications to MRI
研究组 & 干预措施
Neoadjuvant chemotherapy
干预措施: Angiomammography (Diagnostic Test)
结局指标
主要结局
Number of patients with a pCR accoreding to angiomammography, based on a 50% reduction in lesion size at angiomammography
时间窗: Cycle 2 (each cycle being 21 days), i.e., after the chemotherapy on day 1 of cycle 2 and before cycle 3.
Prediction of pCR using angiomammography after cycle 2 of neoadjuvant chemotherapy, based on a 50% reduction in lesion size at angiomammography
次要结局
未报告次要终点
