Evaluation of TaiHao Breast Ultrasound Diagnosis Software

Study Overview
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Brief Summary
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The BR-USCAD DS Module is a computer-assisted detection and diagnosis software based on a deep learning algorithm. This retrospective, fully-crossed, multi-reader, multi-case (MRMC) study aims to compare the performances of readers without and with the aid of the Breast Ultrasound Image Reviewed with Assistance of Computer-Assisted Detection and Diagnosis System (BR-USCAD DS) in interpreting breast ultrasound images of lesions.

Official Title
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Evaluation of TaiHao Breast Ultrasound Diagnosis Software

Conditions
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Breast Cancer, Breast Diseases

Intervention / Treatment
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* Diagnostic Test: Reader Group X - Session 1
* Diagnostic Test: Reader Group Y - Session 1
* Diagnostic Test: Reader Group X - Session 2
* Diagnostic Test: Reader Group Y - Session 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: B-mode breast ultrasound image 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: Breast lesion images acquired after biopsy or surgery. 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First session: manual review first and then review with CADx<br>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. | Diagnostic Test: Reader Group X - Session 1<br>* 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.<br>|
| Active Comparator: First session: review with CADx first and then manual review<br>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. | Diagnostic Test: Reader Group Y - Session 1<br>* 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.<br>|
| Active Comparator: Second session: manual review first and then review with CADx<br>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. | Diagnostic Test: Reader Group X - Session 2<br>* 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.<br>|
| Active Comparator: Second session: review with CADx first and then manual review<br>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. | Diagnostic Test: Reader Group Y - Session 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the Area Under the LROC Curve | The area under the LROC curve (AUC_LROC) on the diagnosis of benign and malignant lesions was computed and compared for Aim 1 (baseline) and Arm 2 (with BU-CAD assistance) studies. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies. | Each reader's reading time of a case was automatically recorded by the BU-CAD system. the average reading times of 16 readers with and without outlier reading times were compared between the aided and unaided sessions using the paired t-test. | 10 weeks | 
| The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies. | The mean sensitivity, specificity, PPV, and NPV of 16 readers were calculated and compared between the aided and unaided sessions using McNemar's test. | 10 weeks |