Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment
研究概览
简要总结
The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of rectal cancer.
详细描述
Rectal cancer is the second cause of mortality after lung cancer in industrialized countries and represent 28% of colorectal carcinomas. Despite major improvements in diagnosis and treatment made those last years,mortality and morbidity remains high, because of high prevalence of metastasis and local recurrence. A accurate initial staging is of paramount importance for an appropriate treatment (neoadjuvant chemiotherapy and radiotherapy, surgery).
Actually, there is no international consensus concerning imaging for the staging of rectal cancer and modalities used are variable from one center to another.
WB-MRI represented a attractive and promising technique for the staging of rectal cancer, free of ionizing radiation .
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rectal cancer T3 N+ or T3 or T4
排除标准
- •renal failure
- •allergy to iodinated contrast medium
- •contraindication to MRI
结局指标
主要结局
Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment
时间窗: baseline and 1 week before surgery
We will compare for each body region the findings of the whole-body MRI to the FDG-PET-CT considered as the gold-standard and measure sensibility/specificity and diagnostic accuracy of the whole-body MRI for distant lesions of rectal cancer.
次要结局
- Tumoral regression after neoadjuvant treatment(baseline and six weeks after the end of the neoadjuvant treatment)
研究者
Milena Cerny
Dr. Milena Cerny
University of Lausanne Hospitals