An observational study in Breast Cancer, Mass Screening and Cancer Screening, sponsored by The First Affiliated Hospital of the Fourth Military Medical University. Active, not recruiting at 2 sites in China. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by The First Affiliated Hospital of the Fourth Military Medical University · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 6,333 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →The First Affiliated Hospital of the Fourth Military Medical University is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
5714 women are needed (at least 12 cancer cases are expected with 80% power and 20% dropout)
Exclusion Criteria:
Diagnostic Test: Conventional-reading
Diagnostic Test: Second-reading
Diagnostic Test: Concurrent-reading
Diagnostic Test: Tow views-reading
Diagnostic Test: Handheld US-screening
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.
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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of the Fourth Military Medical University