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临床试验/NCT02786199
NCT02786199Unknown不适用

Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Recurrence-free survival

研究概览

简要总结

Histological grade of hepatocellular carcinoma (HCC) is an important prognostic factor affecting patient survival. It has been divided into four grades from I to IV on the basis of histological differentiation. Grade I is the best differentiated consisting of small tumor cells arranged in thin trabeculae. Cells with higher grade are larger and less differentiated with hyperchromatic nuclei and loss of trabecular pattern.

Ultrasound is an imaging modality frequently used to evaluate liver tumors because of its convenience, real-time, less expensive and no radiation exposure. However, ultrasonographic evaluation by conventional B-mode image is semi quantitative and subjective. It still cannot replace liver biopsy for the evaluation of HCC.

This study is aimed to quantify the image characters of B-mode image and the scatterer properties using Nakagami distribution. Nakagami parameter is a general model to describe the distribution of scatterers. Therefore, the investigators hypothesized that Nakagami parameter may also reflect the histological changes in different grades of HCC.

In this study, the resected HCC tumor samples will be collected from the participants who are going to receive surgical resection, and the tumor US images and Nakagami values will be obtained via the single-element ultrasound system. The correlation between the ultrasound backscatter parameter and the differentiation grade will be analyzed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 to 75
  • Patients with HCC who underwent surgery
  • The resected tumor was measured larger than 3 cm

排除标准

  • Patients who have received other treatment in 6 months
  • Patients who couldn't regular follow-up

结局指标

主要结局

Recurrence-free survival

时间窗: within two years after surgery

Suspected recurrences will be confirmed by CT or MRI.

Liver-related mortality

时间窗: five years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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