NCT02777463已完成不适用
The Prediction Using Diffusion-weighted MRI of the Response Evaluation in Borderline Resectable Pancreatic Cancer.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The statistical analysis of the correlation between pretreatment ADC value of diffusion MRI and pathologic response evaluated by Evans grade in patients with borderline resectable pancreatic carcinoma (BRPC) who undergo neoadjuvant therapy.
研究概览
简要总结
To investigate the correlation between pretreatment ADC value of diffusion MRI and pathologic response in patients with borderline resectable pancreatic carcinoma who undergo neoadjuvant therapy.
详细描述
Aim: The prediction using diffusion-weighted MRI of the response evaluation in borderline resectable pancreatic cancer.
Study design: Single institution. Single arm. Prospective Phase II Study.
Number of case: 28
Patients: The prediction using dMRI of the response evaluation in borderline resectable pancreatic carcinoma (BRPC) in neoadjuvant therapy.
Disease: Pancreatic carcinoma
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The statistical analysis of the correlation between pretreatment ADC value of diffusion MRI and pathologic response evaluated by Evans grade in patients with borderline resectable pancreatic carcinoma (BRPC) who undergo neoadjuvant therapy.
时间窗: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
次要结局
- The statistical analysis of the correlation between pretreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
- The statistical analysis of the correlation between posttreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
- The statistical analysis of the correlation between the ratio of posttreatment/pretreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
- The statistical analysis of the correlation between pretreatment ADC value of BRPC tumor in a largest diameter and the rate of tumor cell destruction.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
- The statistical analysis of the correlation between the ratio of posttreatment/pretreatment ADC value of BRPC tumor in a largest diameter and the rate of tumor cell destruction.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
- The statistical analysis by ROC curve to investigate ADC Cut-off value which predict more than 50% and less than 10% in tumor cell destruction rate.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
- The statistical analysis of the correlation between the ratio of posttreatment/pretreatment ADC value of BRPC tumor in a largest diameter and the ratio of posttreatment/pretreatment SUV max in PET-CT.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
- The statistical analysis by ROC curve to investigate ADC Cut-off value and SUV max cut-off value which predict survival time after surgery more than 2 years and less than 2 years.(Five years after initial therapy.)
- The statistical analysis of the comparison of the accuracy of prediction for pathological diagnosis at abutment site between the ratio of posttreatment/pretreatment ADC value and CT scan.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
- Three correlation between high ADC value/low ADC value/the ratio of posttreatment/pretreatment ADC value and survival time after surgery.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
- The statistical analysis of the correlation between high ADC value/low ADC value/the ratio of posttreatment/pretreatment ADC value and decreasing rate of CA19-9 value.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
- The statistical analysis of the correlation between tumor's limb sign in diffusion MRI and the rate of tumor cell destruction more than 10%.(The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.)
研究者
Hiroki Yamaue
Second Department of Surgery, Wakayama Medical University
Wakayama Medical University
研究点 (1)
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