A multi-center, prospective, cohort study to evaluate the efficiency of breast cancer screening based on Automated Breast Ultrasound (AB US) with remote reading mode.
The burden of breast cancer incidence and mortality is rapidly growing during the past two decades in China. Screening has been proven to be effective in detecting early-stage disease and reducing mortality of 10% to 39% due to breast cancer. US is used as a primary screening method among Chinese women because Asian women characteristically have higher-density breasts than other ethnic groups. However, US is dependent on operator experience, lack of standardized scanning protocols, limited ultrasound physician and heavy workloads. In order to improve the efficiency and quality of breast cancer screening among Chinese women, a new remote screening pattern based on AB US was proposed and studied for breast cancer in China. This multi-center, prospective, cohort study aims to evaluate the efficiency of breast cancer screening based on AB US with remote reading mode. In addition, we will also explore the practice value of AI on AB US screening and efficient image acquiring and reading modes of AB US.
Study Type
OBSERVATIONAL
Enrollment
6,333
Two radiologists interpret at least three views of each breast without AI independently.
One radiologist reads AB US images without AI first, then combines the indications of AI marks to make the final decision.
One radiologist identifies CAD marks first, then quickly browses the entire AB US examination to make the final decision.
The First Affiliated Hospital of Fourth Military Medical University
Xi'an, Shaanxi, China
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, China
The performance of breast cancer screening based on AB US with remote reading mode
The performance of breast cancer screening based on AB US with remote reading mode will be evaluated by cancer detection rate, recall rate, sensitivity, specificity, positive predictive value, early detection of breast cancer, interval cancers and time for image acquisition and interpretation.
Time frame: 4 years
Evaluate the performance of AI on breast cancer screening based on AB US with remote reading mode
Evaluate the performance of AI on breast cancer screening based on AB US with remote reading mode (Conventional-reading vs. Second-reading / Concurrent-reading)
Time frame: 4 years
Evaluate the performance of the image acquisition and interpretation modes in breast cancer screening based on AB US with remote reading mode
Evaluate the performance of the image acquisition and interpretation modes in breast cancer screening based on AB US with remote reading mode (two views vs. three views)
Time frame: 4 years
Evaluate the performance of breast cancer screening according to the breast US device
Evaluate the performance of breast cancer screening according to the breast US device (Hand-held US vs. AB US)
Time frame: 4 years
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Two radiologists interpret only two views of each breast without AI independently.
One radiologist screens the breast cancer using Handheld US and interprets images immediately.