NCT04527510

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

3 years

First QC Date

August 23, 2020

Last Update Submit

April 28, 2024

Conditions

Breast CancerMass ScreeningCancer ScreeningUltrasound ImagingAI (Artificial Intelligence)

Keywords

Remote breast cancer screeningAB USAIScanning and reading patterns

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Evaluate the performance of AI on 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

    4 years

  • Evaluate the performance of breast cancer screening according to the breast US device

    4 years

Study Arms (5)

Conventional-reading

Diagnostic Test: Conventional-reading

Second-reading

Diagnostic Test: Second-reading

Concurrent-reading

Diagnostic Test: Concurrent-reading

Tow-view-reading

Diagnostic Test: Tow views-reading

Handheld US-screening

Diagnostic Test: Handheld US-screening

Interventions

Conventional-readingDIAGNOSTIC_TEST

Two radiologists interpret at least three views of each breast without AI independently.

Conventional-reading
Second-readingDIAGNOSTIC_TEST

One radiologist reads AB US images without AI first, then combines the indications of AI marks to make the final decision.

Second-reading
Concurrent-readingDIAGNOSTIC_TEST

One radiologist identifies CAD marks first, then quickly browses the entire AB US examination to make the final decision.

Concurrent-reading
Tow views-readingDIAGNOSTIC_TEST

Two radiologists interpret only two views of each breast without AI independently.

Tow-view-reading
Handheld US-screeningDIAGNOSTIC_TEST

One radiologist screens the breast cancer using Handheld US and interprets images immediately.

Handheld US-screening

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Any age at 35 and over
  • Screening breast cancer with AB US
  • Obtaining written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of Fourth Military Medical University

Xi'an, Shaanxi, 710000, China

Location

The First Affiliated Hospital of the Fourth Military Medical University

Xi'an, Shaanxi, China

Location

Related Publications (1)

  • Dang X, Gao Y, Ju Y, Yuan X, Lin H, Ren Y, Xiao Y, Shu R, Gu X, Moon WK, Song H. Automated Breast Ultrasound With Remote Reading for Primary Breast Cancer Screening: A Prospective Study Involving 46 Community Health Centers in China. AJR Am J Roentgenol. 2025 Jan;224(1):e2431830. doi: 10.2214/AJR.24.31830. Epub 2024 Oct 23.

    PMID: 39440797DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hongping Song, PHD,MD

    Xijing hospital of The fourth military medical university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2020

First Posted

August 26, 2020

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion

August 1, 2025

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations

CN(2)