Clinical Impact of Dedicated MR Staging of Ovarian Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Diagnostic performance of DW-MRI to predict a complete cytoreductive surgery
研究概览
简要总结
The only chance of cure for patients with advanced stage ovarian cancer is complete cytoreductive surgery (CRS). The only way to determine whether complete CRS can be achieved is by a laparoscopy. However, diffusion-weighted magnetic resonance imaging (DW-MRI) has a very high sensitivity to detect small volume malignant disease, making it a potentially suitable staging tool. Aim of this study is to determine the performance of DW-MRI for predicting whether complete CRS can be achieved.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced stage (FIGO stage III or IV) ovarian cancer scheduled for primary or interval cytoreductive surgery
- •Age >18 years
- •Written and signed informed consent
- •Able to read and write Dutch
排除标准
- •Patients with contraindications for MRI
- •Patients with contraindications for CRS
- •Known additional malignancy
结局指标
主要结局
Diagnostic performance of DW-MRI to predict a complete cytoreductive surgery
时间窗: 1 month
Patients will undergo an additional MRI, besides their regular diagnostic workup, for assessing the extent of peritoneal carcinomatosis. Whether or not complete cytoreductive surgery is feasible will be determined on DW-MRI independently by two radiologists. The outcome wil be defined as the number of cytoreductive procedures correctly predicted by DW-DWI.
次要结局
未报告次要终点