Application of Ultrasound Artificial Intelligence and Elastography in Differential Diagnosis of Breast Nodules
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|ClinicalTrials.gov Identifier: NCT03887598|
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment|
|Breast Cancer||Device: Ultrasound diagnosis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||A Multi-center Study of Differential Diagnosis Breast Nodules by Ultrasound Artificial Intelligence and Ultrasound Elastography|
|Actual Study Start Date :||January 18, 2019|
|Estimated Primary Completion Date :||January 18, 2020|
|Estimated Study Completion Date :||February 18, 2020|
Those with one or more breast nodules, age 18 or older, upcoming FNAB or surgery and signed informed consent.Those without adverse effects on the test or threatening other candidates, such as mental illness, pregnancy, poor ultrasound image quality, history of breast surgery or breast biopsy, simple cystic nodules, calcification, excessive mass or too small, the S-DetectTM system can not identify the boundary of the tumor, the basic information is incomplete.
Device: Ultrasound diagnosis
Ultrasound diagnosis of lesions with Samsung S-Detect and ECI technology
- Benign or malignant lesions as determined by pathology [ Time Frame: Before surgery or biopsy ]The pathological diagnosis of benign or malignant lesions from surgery samples
- Elastic ratio [ Time Frame: Before surgery or biopsy ]Clear ECI value
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887598
|Contact: Li-Qiang Zhou, MDfirstname.lastname@example.org|
|Wuhan, Hubei, China, 430030|
|Contact: Xin-Wu Cui, PhD,MD 15927103161 email@example.com|
|Contact: You-Bin Deng, PhD,MD 13871197838 firstname.lastname@example.org|
|Study Chair:||Xin-Wu Cui, PhD,MD||Tongji Hospital|
|Study Chair:||You-Bin Deng, PhD,MD||Tongji Hospital|