Radiomics of Multiparametric MRI for Neoadjuvant Chemotherapy Outcomes Assessment in Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- predicting pathological complete response (pCR) or no response (NR)
研究概览
简要总结
This is a single-arm, multicentre study that aims to assess whether Radiomics combining multiparametric MRI and clinical data could be a good predictor of the responses to neoadjuvant chemotherapy in Breast Cancer.
详细描述
Patients undergo multiparametric MRI (including T2WI, DWI and DCE-MRI) at baseline, after 2 courses of neoadjuvant chemotherapy, and prior to the surgery at least 8 weeks after the treatment procedure. Patients undergo biopsy test in one week after the baseline MRI scan to detect the biomarkers including ER, PR, Her-2 and Ki-67, which can be used to select the treatment plan referring to the NCCN clinical guidelines. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens.
After completion of treatment procedure, patients are followed up for 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •biopsy-proven invasive breast cancer;
- •received complete neoadjuvant chemotherapy and no treatment has been done before;
- •surgery was performed after completion of neoadjuvant chemotherapy, after which pCR was confirmed by postoperative pathological examination;
- •pretreatment MRI data within a month before the start of the treatment was eligible, including T2WI, DWI and DCE-MRI.
排除标准
- •not completing neoadjuvant chemoradiotherapy;
- •not undergoing surgery at our hospital, or pCR was not assessed;
- •lack of T2WI, or DWI or DCE-MRI data;
- •insufficient MRI quality to obtain measurements (e.g., owing to motion artifacts);
- •had unilateral multifocal cancers, and the correlation between the tumor in MR images and postoperative pathological examination was uncertain.
结局指标
主要结局
predicting pathological complete response (pCR) or no response (NR)
时间窗: 20 weeks
The value of Radiomics of multiparametric MRI in predicting responses to neoadjuvant chemotherapy, including pathological complete response (pCR) and no response (NR).
5 years for Overall survival
时间窗: 5 years
The association between Radiomics of multiparametric MRI and overall survival (OS), which defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes.
5 years for Disease free survival
时间窗: 5 years
The association between Radiomics of multiparametric MRI and disease free survival (DFS), which defined as the time from the beginning of neoadjuvant chemotherapy to the confirmed time of recurrence or metastatic disease, or death due to any other cause.
次要结局
未报告次要终点
研究者
Zhenyu Liu
Associate Professor
Chinese Academy of Sciences