NCT03706534

Breast Ultrasound Image Reviewed With Assistance of Deep Learning Algorithms

Breast Ultrasound Image Reviewed With Assistance of Deep Learning

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Samsung Medison · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

This study evaluates a second review of ultrasound images of breast lesions using an interactive "deep learning" (or artificial intelligence) program developed by Samsung Medical Imaging, to see if this artificial intelligence will help the Radiologist make more accurate diagnoses.

Detailed description

Using ultrasound images prospectively acquired, the purpose of this study entails a second review of ultrasound images with suspicious breast lesions using an interactive "deep learning" (or artificial intelligence) program developed by SamsungMedison Co.,Ltd. The images will be reviewed by the radiologists twice: first without, and then with assistance of artificial intelligence program by SamsungMedison Co., Ltd. BIRADS system will be used in this study. The objectives of the study are twofold: to quantify the statistical equivalence of radiologists' opinion and AI's output (CADe), and to check BIRADS score-based diagnostic accuracy (CADx) that is gained by the Radiologists' use of this interactive tool

Conditions

• Breast Cancer
• Breast Lesions
• Breast Mass

Interventions

Type	Name	Description
DEVICE	Ultrasound Image review with CADe	This software is a computer-aided detection (CADe) software application, designed to assist radiologist to analyze breast ultrasound images. S-Detect automatically segments and classifies shape, orientation, margin, lesion boundary, echo pattern, and posterior feature characteristics of user-selected region of interest. The device uses deep learning methods to perform tissue segmentation and classification of images.
DEVICE	Ultrasound Image review with CADx	This software is also a computer-assisted diagnostic(CADx) software application, designed to assist a medical doctor in determining diagnosis by presenting whether a lesion is malignant in a breast ultrasound image obtained from an ultrasound imaging device.
DEVICE	Ultrasound Image manual review	The images will be reviewed by the radiologists using BIRADS scheme without any assistance of artificial assistance. This review will be done off-line using a separate program in entirely manual mode. During this review, BIRADS descriptor choices by each radiologist and the time it takes for the radiologist to make such decision will be stored.
PROCEDURE	Biopsy	Suspicious lesions found on breast ultrasound are then followed either by ultrasound guided biopsy or ultrasound imaging every 6 months for two years. For those who undergo biopsy, ultrasound provides images which are used to localize the lesion and guide the placement of the biopsy needle. The sample is sent to pathology for diagnosis, while the ultrasound guidance images are stored. For those who have imaging follow-up, ultrasound images of the breast mass are obtained, digitally stored and interpreted by the radiologist typically using BIRADS scheme.

Timeline

• Start date: 2018-09-20
• Primary completion: 2019-11-30
• Completion: 2020-01-31
• First posted: 2018-10-16
• Last updated: 2019-10-29

Locations

1 site across 1 country: United States