Remote Breast Cancer Screening Study

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04527510
• Other study ID #: 2021LC2210
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital of the Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 6333
• Est. completion date: August 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Fourth Military Medical University	Xi'an	Shaanxi
China	The First Affiliated Hospital of the Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of the Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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