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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03887598
Enrollment
2000
Registered
2019-03-25
Start date
2019-01-18
Completion date
2020-02-18
Last updated
2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Artificial Intelligence; Ultrasound; Breast nodule; ECI

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.

Interventions

Ultrasound diagnosis of lesions with Samsung S-Detect and ECI technology

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Taizhou Hospital
CollaboratorOTHER
Wuhan Hospital of Traditional Chinese Medicine
CollaboratorOTHER
Macheng People's Hospital
CollaboratorUNKNOWN
Huangshi Central Hospital
CollaboratorOTHER
Affiliated Hospital of Jiangsu University
CollaboratorOTHER
The First People's Hospital of Yichang
CollaboratorUNKNOWN
Yichang Second People's Hospital
CollaboratorOTHER
Xiangyang Central Hospital
CollaboratorOTHER
The Second Hospital of Anhui Medical University
CollaboratorOTHER
Anqing People's Hospital
CollaboratorUNKNOWN
Huainan People's Hospital
CollaboratorUNKNOWN
Wenzhou Central Hospital
CollaboratorOTHER
Xuzhou First People's Hospital
CollaboratorUNKNOWN
The Central Hospital of Lishui City
CollaboratorOTHER
Huai'an First People's Hospital
CollaboratorOTHER
WISCO General Hospital
CollaboratorUNKNOWN
First People's Hospital of Jiangxia District, Wuhan City
CollaboratorUNKNOWN
Enshi State Central Hospital
CollaboratorUNKNOWN
Lianyungang Third People's Hospital
CollaboratorUNKNOWN
First People's Hospital of Xianyang
CollaboratorOTHER
Xin-Wu Cui
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Benign or malignant lesions as determined by pathologyBefore surgery or biopsyThe pathological diagnosis of benign or malignant lesions from surgery samples
Elastic ratioBefore surgery or biopsyClear ECI value

Countries

China

Contacts

Primary ContactLi-Qiang Zhou, MD
zlq_1118@hust.edu.cn15387076275

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026