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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional-reading |
| ||
| Second-reading |
| ||
| Concurrent-reading |
| ||
| Tow-view-reading |
| ||
| Handheld US-screening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional-reading | Diagnostic Test | Two radiologists interpret at least three views of each breast without AI independently. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 years |
| Evaluate the performance of the image acquisition and interpretation modes in breast cancer screening based on AB US with remote reading mode |
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Inclusion Criteria:
Exclusion Criteria:
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5714 women are needed (at least 12 cancer cases are expected with 80% power and 20% dropout)
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| Name | Affiliation | Role |
|---|---|---|
| Hongping Song, PHD,MD | Xijing hospital of The fourth military medical university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fourth Military Medical University | Xi'an | Shaanxi | 710000 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39440797 | Derived | Dang X, Gao Y, Ju Y, Yuan X, Lin H, Ren Y, Xiao Y, Shu R, Gu X, Moon WK, Song H. Automated Breast Ultrasound With Remote Reading for Primary Breast Cancer Screening: A Prospective Study Involving 46 Community Health Centers in China. AJR Am J Roentgenol. 2025 Jan;224(1):e2431830. doi: 10.2214/AJR.24.31830. Epub 2024 Oct 23. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Second-reading | Diagnostic Test | One radiologist reads AB US images without AI first, then combines the indications of AI marks to make the final decision. |
|
| Concurrent-reading | Diagnostic Test | One radiologist identifies CAD marks first, then quickly browses the entire AB US examination to make the final decision. |
|
| Tow views-reading | Diagnostic Test | Two radiologists interpret only two views of each breast without AI independently. |
|
| Handheld US-screening | Diagnostic Test | One radiologist screens the breast cancer using Handheld US and interprets images immediately. |
|
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) |
| 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) | 4 years |
| The First Affiliated Hospital of the Fourth Military Medical University |
| Xi'an |
| Shaanxi |
| China |
| D017437 |
| Skin and Connective Tissue Diseases |