Remote Breast Cancer Screening Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Ultrasound Imaging; Mass Screening; Cancer Screening; AI (Artificial Intelligence)
• Intervention / Treatment: Diagnostic test: Conventional-reading; Diagnostic test: Second-reading; Diagnostic test: Concurrent-reading; Diagnostic test: Tow views-reading; Diagnostic test: Handheld US-screening

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.

• Study Type: Observational
• Enrollment (Actual): 6333

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • The First Affiliated Hospital of Fourth Military Medical University
    • Xi'an, Shaanxi, China
      • The First Affiliated Hospital of the Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

5714 women are needed (at least 12 cancer cases are expected with 80% power and 20% dropout)

Description

Inclusion Criteria:

1. Any age at 35 and over
2. Screening breast cancer with AB US
3. Obtaining written informed consent

Exclusion Criteria:

1. symptoms of breast cancer
2. surgical of breast within 12 months prior to the study
3. known diagnosis breast cancer
4. poor image quality
5. follow-up was less than 12 months

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Conventional-reading	Diagnostic test: Conventional-reading; Two radiologists interpret at least three views of each breast without AI independently.
Second-reading	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.
Concurrent-reading	Diagnostic test: Concurrent-reading; One radiologist identifies CAD marks first, then quickly browses the entire AB US examination to make the final decision.
Tow-view-reading	Diagnostic test: Tow views-reading; Two radiologists interpret only two views of each breast without AI independently.
Handheld US-screening	Diagnostic test: Handheld US-screening; One radiologist screens the breast cancer using Handheld US and interprets images immediately.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of the Fourth Military Medical University
• Investigators: Principal Investigator: Hongping Song, PHD,MD, Xijing Hospital of the Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: AI; Remote breast cancer screening; AB US; Scanning and reading patterns
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2021LC2210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No