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临床试验/NCT03887598
NCT03887598Unknown不适用

A Multi-center Study of Differential Diagnosis Breast Nodules by Ultrasound Artificial Intelligence and Ultrasound Elastography

Xin-Wu Cui1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2019年1月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Elastic ratio

研究概览

简要总结

The application of computer-aided diagnosis (CAD) technology "S-Detect" enables qualitative and quantitative automated analysis of ultrasound images to obtain objective, repeatable and more accurate diagnostic results. The Elastic Contrast Index (ECI) technique, unlike conventional strain-elastic imaging techniques, can evaluate the elastic distribution in the region of interest. The purpose of the study was to evaluate the differential diagnosis value of ultrasound S-Detect technology for benign and malignant breast nodules and evaluate the differential diagnosis consistency of the ultrasound S-Detect technique and the examiner for benign and malignant breast nodules and explore the differential diagnosis value of Samsung ultrasound elastic contrast Index (ECI) technique for benign and malignant breast nodules.

详细描述

Breast cancer is the most common malignancy in women and the second leading cause of cancer deaths worldwide. Therefore, early detection of breast cancer and timely treatment are of great significance for controlling and reducing breast cancer mortality. Breast ultrasound is an adjunct to extensive use in the detection of breast cancer, but ultrasound is highly technically dependent on the examiner, and the results are greatly influenced by the subjective nature of the examiner, adding unnecessary surgery and puncture, which causes great problems for clinicians and patients.Moreover, the value of conventional ultrasound in the differential diagnosis of breast mass is still limited, and the emergence of new technologies such as artificial intelligence and elastography has improved the accuracy of ultrasound diagnosis to varying degrees.

S-Detect technology is a computer-aided (CAD) system recently developed by Samsung Medical Center for breast ultrasound to assist in morphological analysis based on the Breast Imaging Reporting and Data System (BI-RADS) description and final assessment.This provides a new way to identify the benign and malignant breast nodules.

The E-Breast technique, unlike conventional strain-elastic imaging technology, performs an elastic analysis of the entire two-dimensional image.Moreover, when measuring the elastic ratio, it is only necessary to place a region of interest (ROI) at the nodule.Compared with the average elasticity of the surrounding area, it is more reflective of the elastic ratio of the mass to the surrounding tissue.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Had breast lesions detected by ultrasound
  • Age 18 or older
  • Upcoming FNAB or surgery
  • Signing informed consent

排除标准

  • Patients who had received a biopsy of breast lesion before the ultrasound examination
  • Can not cooperate with the test operation
  • Patients who were pregnant or lactating
  • Patients who were undergoing neoadjuvant treatment.

结局指标

主要结局

Elastic ratio

时间窗: Before surgery or biopsy

Clear ECI value

Benign or malignant lesions as determined by pathology

时间窗: Before surgery or biopsy

The pathological diagnosis of benign or malignant lesions from surgery samples

次要结局

未报告次要终点

研究者

发起方
Xin-Wu Cui
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xin-Wu Cui

Professor

Tongji Hospital

研究点 (1)

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