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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
300
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.
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.
University of Rochester
Rochester, New York, United States
Concordance rate
Breast Imaging Reporting and Data System descriptors suggested by S-Detect for Breast are in good agreement with those selected by experts. In other words, the Breast Imaging Reporting and Data System Lexicon values generated by S-Detect for Breast are not statistically different from the consensus of experts. Breast Imaging Reporting and Data System Assessment Category Score: The user makes the final decision on the Assessment Category Score. Using this Score, S-Detect displays the assessment description. Category 0: Incomplete - Need Additional Imaging Evaluation Category 1: Negative Category 2: Benign Category 3: Probably Benign Category 4a: Low suspicion for malignancy Category 4b: Moderate suspicion for malignancy Category 4c: High suspicion for Malignancy Category 5: Highly Suggestive of Malignancy Category 6: Known Biopsy-Proven Malignancy
Time frame: 2 days
Reporting time
Measure reporting time of Breast Imaging Reporting and Data System Lexicon value in Breast imaging by radiologists without S-Detect for Breast and also measured report time by radiologists with S-Detect for Breast.
Time frame: 2 day
Consensus
Evaluate the consensus between manually reading of Breast Imaging without assistance and Automatically detection results(Breast Imaging Reporting and Data System Lexicons). Average of consensus is evaluated in both of Expert group and non-expert group.
Time frame: 2 day
Accuracy
Comparing to the Breast Biopsy results, The accuracy of Breast Imaging results by radiologists with CADx will be evaluated.
Time frame: 7 day
Sensitivity
Comparing to the Breast Biopsy results, The sensitivity of Breast Imaging results by radiologists with CADx will be evaluated.
Time frame: 7 day
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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.
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.
Specificity
Comparing to the Breast Biopsy results, The specificity of Breast Imaging results by radiologists with CADx will be evaluated.
Time frame: 7 day
Area Under Curve
Comparing to the Breast Biopsy results, Area Under Curve (ROC analysis) of Breast Imaging results by radiologists with CADx will be evaluated.
Time frame: 7 day