Magnetomotoric Ultrasound (MMUS) in the Staging of Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology
研究概览
简要总结
Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. The aim is to improve diagnosis of mesolectal lymph nodes.
详细描述
Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. Nanoparticles are injected close to the rectal cancer and migrate to adjacent lymph nodes.The time-varying magnetic field will influence the nano particles in the lymph node enhancing diagnosis of affected lymph nodes. The aim is to improve diagnosis of mesolectal lymph nodes and compare the results of magnetomotoric ultrasound with MRI and final histopathology.
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
- •Rectal cancer
- •Scheduled for total mesorectal surgery
- •Informed consent
排除标准
- •Not able to give informed consent
- •Synchronus colorectal cancer
结局指标
主要结局
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology
时间窗: Approximately 1 hour after MMUS
Evaluation of the accuracy of MMUS in detecting lymph node metastases in rectal cancer. The results of the MMUS (malignant or benign lymph nodes) will be compared with final histopathology. The accuracy will be expressed in sensitivity (%), specificity (%) and overall accuracy (% correctly staged lymph nodes with MMUS)
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with preoperative MRI
时间窗: Approximately 1 hour after MMUS
Evaluation of the accuracy of MMUS in detecting lymph node metastases in rectal cancer in comparison to standard staging (MRI). The results of the MMUS (malignant nodes or benign nodes) will be compared with the results of preoperative MRI (malignant or benign lymph nodes) and the final histopathology. The accuracy will be expressed in sensitivity (%), specificity (%) and overall accuracy (% correctly staged lymph nodes) with MMUS and MRI.
次要结局
未报告次要终点