Remote Breast Cancer Screening Study

NCT ID: NCT04527510

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

6333 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-08-31

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional-reading

Conventional-reading

Intervention Type DIAGNOSTIC_TEST

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

Second-reading

Second-reading

Intervention Type DIAGNOSTIC_TEST

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

Concurrent-reading

Concurrent-reading

Intervention Type DIAGNOSTIC_TEST

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

Tow-view-reading

Tow views-reading

Intervention Type DIAGNOSTIC_TEST

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

Handheld US-screening

Handheld US-screening

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Conventional-reading

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Concurrent-reading

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

Intervention Type DIAGNOSTIC_TEST

Tow views-reading

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

Intervention Type DIAGNOSTIC_TEST

Handheld US-screening

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of the Fourth Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Song Hongping

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hongping Song, PHD,MD

Role: PRINCIPAL_INVESTIGATOR

Xijing hospital of The fourth military medical university

Locations

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The First Affiliated Hospital of Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status

The First Affiliated Hospital of the Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 39440797 (View on PubMed)

Other Identifiers

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2021LC2210

Identifier Type: -

Identifier Source: org_study_id

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