Shear Wave Elastography of Rectal Adenomas and Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- SWE accuracy
研究概览
简要总结
The diagnosis of rectal lesions is a challenging task, and the accuracy of the primary staging is important preoperatively. A relatively novel technology makes it possible to measure the tissue stiffness during endorectal ultrasonography.
The purpose of this study is to evaluate the diagnostic value of Shear Wave Elastography (SWE). The hypothesis is that the tissue stiffness is higher in malignant tissue than in benign lesions.
详细描述
This study will include patients with an endoscopy verified rectal lesion referred to the radiology department for pretreatment evaluation.
During the investigation, patients will undergo magnetic resonance imaging (MRI) and endorectal ultrasonography (ERUS). During the ERUS, the tissue stiffness of the lesion and visible lymph nodes will be measured using the SWE technology.
Hypotheses:
- Tumour stiffness measurement by SWE gives a statistically significantly higher value in malignant processes than in benign rectal tumors.
- Tissue stiffness measurement with SWE gives a statistically significantly higher value in lymph node metastases than in reactive enlarged lymph nodes.
- There is a statistically significant correlation between SWE and MRI apparent diffusion coefficient (ADC)
Histopathology report of surgical specimen will serve as endpoint.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults above 18 years of age
- •Rectal lesions discovered during endoscopy
- •Lesions located no more than 15 cm above the anal verge
排除标准
- •Non-eligibility for MRI (e.g. claustrophobia, implants)
- •Preoperative radiotherapy and/or chemotherapy
结局指标
主要结局
SWE accuracy
时间窗: 1 month
The accuracy of SWE value as compared with the histopathology report
次要结局
- SWE and ADC measurement(1 week)