Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast
NCT ID: NCT06352684
Last Updated: 2024-04-08
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
1000 participants
OBSERVATIONAL
2023-11-24
2025-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cancer group
confirmed as a breast cancer (DCIS or invasive cancer) through the subsequent biopsy conducted within following 1 year of the ultrasound exam.
CadAI-B for Breast
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.
Benign group
Either confirmed as a benign through the subsequent biopsy conducted within following 1 year of the ultrasound exam or showing stability on more than 2 years of imaging follow-up after initial diagnosis
CadAI-B for Breast
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.
Normal group
Interpreted as BI-RADS 1 (Negative) with no cancers on the ultrasound exam
CadAI-B for Breast
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.
Interventions
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CadAI-B for Breast
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.
Eligibility Criteria
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Inclusion Criteria
* Women with breast cancer (DCIS or invasive cancer) diagnosed via biopsy
* Women who had been followed for more than 2 years after initial US examination
Exclusion Criteria
* women who had US images containing artifacts affecting the review of images
19 Years
FEMALE
Yes
Sponsors
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Severance Hospital
OTHER
BeamWorks Inc.
INDUSTRY
Responsible Party
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Locations
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Yonsei University Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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RS-2023-00227526
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DP0001-SEV-CAB-II
Identifier Type: -
Identifier Source: org_study_id
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