Evaluation of TaiHao Breast Ultrasound Diagnosis Software
NCT ID: NCT04551105
Last Updated: 2022-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2020-08-15
2020-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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First session: manual review first and then review with CADx
Reader Group X interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system.
Reader Group X - Session 1
Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.
First session: review with CADx first and then manual review
Reader Group Y interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI.
Reader Group Y - Session 1
Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.
Second session: manual review first and then review with CADx
At least 4 weeks after first session for memory washing out. Reader Group X interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI.
Reader Group X - Session 2
Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.
Second session: review with CADx first and then manual review
At least 4 weeks after first session for memory washing out. Rader Group Y interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system.
Reader Group Y - Session 2
Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.
Interventions
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Reader Group X - Session 1
Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.
Reader Group Y - Session 1
Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.
Reader Group X - Session 2
Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS.
Reader Group Y - Session 2
Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS.
Eligibility Criteria
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Inclusion Criteria
* Female, age 21 or older
* Breast lesion images acquired before a biopsy or surgery - these images were retrospectively collected with histology report.
* Non-biopsied benign lesions with negative follow-up for a minimum of 24 months
* At least two orthogonal views of a lesion
Exclusion Criteria
* Any breast surgeries or interventional procedures in the 12 months prior to ultrasound imaging
* Case demonstrating administrative or technical errors
* Multiple lesions in one 2-D ultrasound image
* Breast ultrasound images with Doppler, elastography, or other overlays present
* Case with less than 2-year follow-up and without biopsy confirmation
21 Years
FEMALE
No
Sponsors
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Columbia University
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Virginia Polytechnic Institute and State University
OTHER
TaiHao Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shih Chung Lo, Ph.D.
Role: STUDY_DIRECTOR
Arlington Innovation Center: Health Research - Virginia Tech
Locations
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Arlington Innovation Center: Health Research - Virginia Tech
Arlington, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TaiHao BR-USCAD VT 20-249
Identifier Type: -
Identifier Source: org_study_id
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