Application of Ultrasound Artificial Intelligence and Elastography in Differential Diagnosis of Breast Nodules

• Conditions: Breast Cancer
• Interventions: Device: Ultrasound diagnosis

• Registration Number: NCT03887598
• Lead Sponsor: Xin-Wu Cui

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2019-01-18
• Status Verified: 2019-03
• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-21
• Last Update Submitted: 2019-03-23
• Study First Posted: 2019-03-25
• Last Update Posted: 2019-03-26
• Primary Completion: 2020-01-18
• Study Completion: 2020-02-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

1. Had breast lesions detected by ultrasound
2. Age 18 or older
3. Upcoming FNAB or surgery
4. Signing informed consent

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
breast nodule	Ultrasound diagnosis	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.

Primary Outcome Measures

Name	Time	Method
Elastic ratio	Before surgery or biopsy	Clear ECI value
Benign or malignant lesions as determined by pathology	Before surgery or biopsy	The pathological diagnosis of benign or malignant lesions from surgery samples

Trial Locations

Locations (1)

Xin-Wu Cui; 🇨🇳 Wuhan, Hubei, China