Ignite Creation Date:
2024-05-06 @ 12:56 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03887598
Status:
UNKNOWN
Last Update Posted:
2019-03-26
First Post:
2019-03-21
Brief Title:
Application of Ultrasound Artificial Intelligence and Elastography in Differential Diagnosis of Breast Nodules
Sponsor:
Xin-Wu Cui
Organization:
Tongji Hospital
Study Overview
Official Title:
A Multi-center Study of Differential Diagnosis Breast Nodules by Ultrasound Artificial Intelligence and Ultrasound Elastography
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientsMoreover 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 assessmentThis 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 imageMoreover when measuring the elastic ratio it is only necessary to place a region of interest ROI at the noduleCompared with the average elasticity of the surrounding area it is more reflective of the elastic ratio of the mass to the surrounding tissue
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 assessmentThis 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 imageMoreover when measuring the elastic ratio it is only necessary to place a region of interest ROI at the noduleCompared with the average elasticity of the surrounding area it is more reflective of the elastic ratio of the mass to the surrounding tissue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None