NCT04527510

Remote Breast Cancer Screening Study

Remote Breast Cancer Screening Based on Automated Breast Ultrasound Among Chinese Women: a Multi-center, Prospective, Cohort Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6,333 (actual)
• Sponsor: The First Affiliated Hospital of the Fourth Military Medical University · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Mass Screening
• Cancer Screening
• Ultrasound Imaging
• AI (Artificial Intelligence)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Conventional-reading	Two radiologists interpret at least three views of each breast without AI independently.
DIAGNOSTIC_TEST	Second-reading	One radiologist reads AB US images without AI first, then combines the indications of AI marks to make the final decision.
DIAGNOSTIC_TEST	Concurrent-reading	One radiologist identifies CAD marks first, then quickly browses the entire AB US examination to make the final decision.
DIAGNOSTIC_TEST	Tow views-reading	Two radiologists interpret only two views of each breast without AI independently.
DIAGNOSTIC_TEST	Handheld US-screening	One radiologist screens the breast cancer using Handheld US and interprets images immediately.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-31
• Completion: 2025-08-01
• First posted: 2020-08-26
• Last updated: 2024-04-30

Locations

2 sites across 1 country: China