Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,614
- 试验地点
- 11
- 主要终点
- Predictive value of eary MRI (14-16 days MRI) for assessing pathological complete response(pCR) at surgery
研究概览
简要总结
The purpose of this study is to investigate if MRI scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.
详细描述
We proposed to constructed multi-parameter predictive model for predicting therapeutic response and pathological complete response(pCR) of patients with rectal cancer who received neoadjuvant chemoradiation. MR radiomics,convolutional neural networks, morphological parameters and quantitative functional parameters derived from diffusion-weighted MR images will be integrated for model construction.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •T3/4 or node positive biopsy-proved primary rectal cancer
- •Suitable for pre-operative chemoradiotherapy and surgical resection
- •No contraindication to MRI
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •History or concurrent of other cancer
- •Previous therapy to pelvis
- •Unable/unwilling to have MRI
- •Pacemaker or implanted defibrillator
- •Pregnancy, lactation or inadequate contraception
- •Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study
- •Unwilling or unable to give informed consent
结局指标
主要结局
Predictive value of eary MRI (14-16 days MRI) for assessing pathological complete response(pCR) at surgery
时间窗: 2 years
A scoring system for predicting pCR will be developed based on MRI parameters and their changes between baseline and early MRI. No viable cancer cells seen in the resection specimen is regarded as pCR
Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pCR
时间窗: 2 years
A scoring system for predicting pCR will be developed based on MRI parameters
次要结局
- Predictive value of eary MRI (14-16 days after initiation of preoperative radio-chemotherapy) for assessing pathological response according to Tumour Regression Grade (TRG)(2 years)
- Feasibility of conducting MRI scans at 7-9 weeks after preoperative radio-chemotherapy(2 years)
- MRI-predicted pCR and MRI-predicted response on long-term disease control and survival(3 years)
- Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pathological response according to Tumour Regression Grade (TRG)(2 years)
研究者
Sun Ying-Shi
Chairman of Department of Radiology
Peking University Cancer Hospital & Institute