Clinical Study of Dynamic Contrast-enhanced Magnetic Resonance Imaging Combined With IVIM-DWI for Early Prediction of Chemosensitivity in Liver Metastasis of Breast Cance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Correlation between DCE-MRI parameters combined with IVIM parameters and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
研究概览
简要总结
The purpose of this study is to further use DCE-MRI and ivim-dwi to predict the chemotherapy sensitivity of liver metastasis of breast cancer at an early stage, and to predict the treatment response of tumor at an early stage by using the changes of their functional parameters, and to compare the efficacy and advantages of IVIM functional parameters and DCE-MRI parameters in predicting the efficacy.To explore the efficacy of "perfusion" and "diffusion" parameters of magnetic resonance imaging as "biomarkers" for early prediction of chemotherapy response and prognosis of breast cancer patients with liver metastasis. And to provide guidance for optimizing the clinical treatment scheme of breast cancer patients with liver metastasis.
At the same time, this study will use the method of artificial intelligence to deeply mine the images, and further find out the indicators for early prediction of the therapeutic effect of liver metastasis of breast cancer.
详细描述
The first MR examination was arranged within 7 days before treatment (baseline). The MRI scanning sequence included conventional T1, T2 weighted imaging, T1+dynamic contrast enhanced imaging, and IVIM-DWI imaging.The second and third MR examinations were arranged within 7 days after the first chemotherapy and the second chemotherapy. The examination steps and parameters were the same as those of the first examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The primary lesion was pathologically confirmed to be breast cancer, and the patients diagnosed by two imaging methods or pathologically confirmed to be liver metastasis of breast cancer had at least one liver metastasis with the longest diameter ≥ 10mm;
- •No second primary malignant tumor;
- •ECOG score, 0-2 ;
- •The organ function is normal and can tolerate chemotherapy and other anti-tumor treatments;
- •The patient plans to receive systemic chemotherapy or systemic anti-tumor treatment, and the whole process of cooperative treatment. The patient has good compliance with the planned treatment and follow-up, can understand the research process of this study and sign a written informed consent；
- •Contraception during the study period and within 6 months after treatment, non lactation period.
排除标准
- •For patients contraindicated to MR examination, such as built-in metal instruments and allergy to contrast agents;
- •The patient had diffuse liver metastasis or the number of liver metastatic tumors was more than 5;
- •Patients who cannot complete 2 cycles of chemotherapy or systemic anti-tumor treatment;
- •Unable to cooperate with follow-up；
- •Patients who are not suitable for the study according to the investigator.
研究组 & 干预措施
Patients with liver metastasis from breast cancer requiring antitumor therapy
Patients with liver metastasis from breast cancer requiring antitumor therapy
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Correlation between DCE-MRI parameters combined with IVIM parameters and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
时间窗: September 2025
Correlation between DCE-MRI parameters (Ktrans, Ve, Kep) combined with IVIM parameters (D\*, D, f) and short-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
Correlation between DCE-MRI parameters combined with IVIM parameters and long-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
时间窗: September 2025
Correlation between DCE-MRI parameters (Ktrans, Ve, Kep) combined with IVIM parameters (D\*, D, f) and long-term efficacy of chemotherapy in patients with liver metastasis of breast cancer
次要结局
- The consistency of DCE-MRI parameters and IVIM parameters between different observers and the same observer.(September 2025)
- Using artificial intelligence method to deeply mine images, find out new indicators to predict the curative effect of liver metastasis treatment of breast cancer in early stage.(September 2025)
研究者
Huang Ping
Clinical Professor
Zhejiang Cancer Hospital