Remote Breast Cancer Screening Study
- Conditions
- Cancer ScreeningAI (Artificial Intelligence)Breast CancerUltrasound ImagingMass Screening
- Interventions
- Diagnostic Test: Conventional-readingDiagnostic Test: Tow views-readingDiagnostic Test: Second-readingDiagnostic Test: Concurrent-readingDiagnostic Test: Handheld US-screening
- Registration Number
- NCT04527510
- Lead Sponsor
- The First Affiliated Hospital of the Fourth Military Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 6333
- Any age at 35 and over
- Screening breast cancer with AB US
- Obtaining written informed consent
- symptoms of breast cancer
- surgical of breast within 12 months prior to the study
- known diagnosis breast cancer
- poor image quality
- follow-up was less than 12 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Conventional-reading Conventional-reading - Tow-view-reading Tow views-reading - Second-reading Second-reading - Concurrent-reading Concurrent-reading - Handheld US-screening Handheld US-screening -
- Primary Outcome Measures
Name Time Method The performance of breast cancer screening based on AB US with remote reading mode 4 years 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.
- Secondary Outcome Measures
Name Time Method Evaluate the performance of AI on breast cancer screening based on AB US with remote reading mode 4 years Evaluate the performance of AI on breast cancer screening based on AB US with remote reading mode (Conventional-reading vs. Second-reading / Concurrent-reading)
Evaluate the performance of the image acquisition and interpretation modes in breast cancer screening based on AB US with remote reading mode 4 years 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)
Evaluate the performance of breast cancer screening according to the breast US device 4 years Evaluate the performance of breast cancer screening according to the breast US device (Hand-held US vs. AB US)
Trial Locations
- Locations (2)
The First Affiliated Hospital of the Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China
The First Affiliated Hospital of Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China