Diffusion-weighted Images as an Additional Method for Diagnosing Histological Types of Nephroblastoma in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children
研究概览
简要总结
Initially, or after preoperative chemotherapy, patients with a kidney tumor are examined on 3T MR scanner or 1.5T MR scanner. A standard MRI study of the abdomen with contrast enhancement is performed. DWI (diffusion weighted) images are included in the standard investigation package and consist of diffusion maps. Then, using Philips workstation (ISP 9.0, Philips, Netherlands), DWI mapping and ADC values collection (mm2/s) are performed. The placement of region of interest (ROI) is selected in the kidney mass in a solid and cystic area with a size up to 100 mm2.
After the preoperative abdomen MRI, a surgical treatment is performed. Histological material is directed to the pathologist, who carried out the histological staging by the malignancy degree (low, intermediate, high). The data is entered into the database and the relationship between ADC values and histological degrees of malignancy of nephroblastoma is investigated
详细描述
Initially, or after preoperative chemotherapy, patients with a kidney tumor are examined on 3T MR scanner or 1.5T MR scanner, using 8-channel body coil. A standard MRI study of the abdomen with contrast enhancement is performed. DWI (diffusion weighted) images are included in the standard investigation package and consist of diffusion maps (DWI 3b) with 3 b-factors (50; 600; 800 or others, optional). Then, using Philips workstation (ISP 9.0, Philips, Netherlands), DWI mapping and ADC values collection (mm2/s) are performed. The placement of region of interest (ROI) is selected in the kidney mass in a solid and cystic area with a size up to 100 mm2. The values are entered in the table due to the stage of the chemotherapy.
After the preoperative abdomen MRI, a surgical treatment is performed. Histological material is directed to the pathologist, who carried out the histological staging by the malignancy degree (low, intermediate, high). The data is entered into the database and the relationship between ADC values and histological degrees of malignancy of nephroblastoma is investigated.
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
- 6 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age under 18 y.o.;
- •Renal mass with confirmed histology.
排除标准
- •Absolute contraindications to magnetic resonance imaging (pacemaker, ferromagnetic implants, etc.);
- •Refusal to sign the informed consent.
结局指标
主要结局
To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children
时间窗: Point 2. after pre-operative chemotherapy up to 1 week
次要结局
- To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children(Point 2. after pre-operative chemotherapy up to 1 week)
- To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;(Point 2. after pre-operative chemotherapy up to 1 week)
- To evaluate the reproducibility and compatibility of the ADC values measurement;(Point 2. after pre-operative chemotherapy up to 1 week)
- To assess the ADC values change in depending according to the provided chemotherapy.(Point 2. after pre-operative chemotherapy up to 1 week)