Artificial Intelligence in Mammography-Based Breast Cancer Screening
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|ClinicalTrials.gov Identifier: NCT04156880|
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Breast cancer (BC) is the most common cancer among women in worldwide and the second leading cause of cancer-related death.
As the corner stone of BC screening, mammography is recognized as one of useful imaging modalities to reduce BC mortality, by virtue of early detection of BC. However, mammography interpretation is inherently subjective assessment, and prone to overdiagnosis.
In recent years, artificial intelligence (AI)-Computer Aided Diagnosis (CAD) systems, characterized by embedded deep-learning algorithms, have entered into the field of BC screening as an aid for radiologist, with purpose to optimize conventional CAD system with weakness of hand-crafted features extraction. For now, stand-alone performance of novel AI-CAD tools have demonstrated promising accuracy and efficiency in BC diagnosis, largely attributed to utilization of convolution neural network(CNNs), and some of them have already achieved radiologist-like level. On the other hand, radiologists' performance on BC screening has shown to be enhanced, by leveraging AI-CAD system as decision support tool. As increasing implementation of commercial AI-CAD system, robust evaluation of its usefulness and cost-effectiveness in clinical circumstances should be undertaken in scenarios mimicking real life before broad adoption, like other emerging and promising technologies. This requires to validate AI-CAD systems in BC screening on multiple, diverse and representative datasets and also to estimate the interface between reader and system. This proposed study seeks to investigate the breast cancer diagnostic performance of AI-CAD system used for reading mammograms. In this work, we will employ a commercially available AI-CAD tool based on deep-learning algorithms (IBM Watson Imaging AI Solution) to identify and characterize the suspicious breast lesions on mammograms. The potential cancer lesions can be labeled and their mammographic features and malignancy probability will be automatically reported. After AI post-processing, we shall further carry out statistical analysis to determine the accuracy of AI-CAD system for BC risk prediction.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: mammography|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Breast Cancer Screening With Mammography: Diagnostic Assessment of an Artificial|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||June 2024|
- Other: mammography
standard mammography including craniocaudal (CC) and mediolateral oblique (MLO) views
- area under curve (AUC) [ Time Frame: 3 years ]area under receiver operating characteristic (ROC) curve in percentage (%)
- accuracy [ Time Frame: 3 years ]proportion of true results(both true positives and true negatives) among whole instances
- sensitivity [ Time Frame: 3 years ]true positive rate in percentage(%) derived by ROC analysis
- specificity [ Time Frame: 3 years ]true negative rate in percentage (%) derived by ROC analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156880
|Contact: Chiu Wing CHUfirstname.lastname@example.org|