Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT03706534
Status:
UNKNOWN
Last Update Posted:
2019-10-29
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Ultrasound Image Reviewed With Assistance of Deep Learning Algorithms
Sponsor:
Samsung Medison
Organization:
Study Overview
Official Title:
Breast Ultrasound Image Reviewed With Assistance of Deep Learning
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
ACTIVE_NOT_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:
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: