Study Results
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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ACTIVE_NOT_RECRUITING
6333 participants
OBSERVATIONAL
2021-01-01
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Conventional-reading
Conventional-reading
Two radiologists interpret at least three views of each breast without AI independently.
Second-reading
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
Concurrent-reading
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
Two radiologists interpret only two views of each breast without AI independently.
Handheld US-screening
Handheld US-screening
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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Screening breast cancer with AB US
3. Obtaining written informed consent
Exclusion Criteria
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
35 Years
FEMALE
No
Sponsors
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The First Affiliated Hospital of the Fourth Military Medical University
OTHER
Responsible Party
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Song Hongping
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
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, China
Countries
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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.
Other Identifiers
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2021LC2210
Identifier Type: -
Identifier Source: org_study_id
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