跳至主要内容
临床试验/NCT06191926
NCT06191926已完成不适用

Diagnostic Performance of Shear Wave Dispersive Imaging to Differenciate Benign From Malignant Breast Lesions: Comparison With Shear Wave Elastography

Korea University Ansan Hospital1 个研究点 分布在 1 个国家目标入组 594 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
594
试验地点
1
主要终点
Elastography and dispersion parameters to determine benign or malignant tumors

研究概览

简要总结

Human soft tissue such as breast tissue has viscoelasticity property. However, most ultrasound has only been measured for elasticity and viscosity has been neglected. Shear wave elastography (SWE) is a ultrasound technique that quantifies tissue elasticity. Shear wave dispersion (SWD) imaging is a newly developed ultrasound technique that evaluates the dispersion slope of shear waves, which is related to the viscosity of biological tissues. The goal of this retrospective study was to compare diagnostic performance between SWE and SWD to distinguish benign from malignant breast masses and to investigate additional role of SWD. Using histological diagnosis of breast lesions as a standard reference, quantitative indices of SWE and SWD were evaluated to diagnose breast cancer, and the diagnostic performance of SWE and SWD was compared.

详细描述

This retrospective study was approved by our institutional review board, which waved the requrement for informed consent. The investigators obtained quantitative parameters of SWE and SWD of solid breast lesions before biopsy. The investigators measured average tumor elasticity and tumor-to-fat elasticity ratio on SWE and average tumor dispersion and tumor-to-fat ratio and on SWD from each breast lesion. Diagnostic performance of SWE and SWD was compared using the area under the curve (AUC), sensitivity, specificity, and accuracy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with histological results

排除标准

  • patients without histological results

结局指标

主要结局

Elastography and dispersion parameters to determine benign or malignant tumors

时间窗: baseline, pre-biopsy

The elastography and dispersion ultrasound parameter values correlated with histological results.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bo Kyoung Seo

Professor

Korea University Ansan Hospital

研究点 (1)

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