Evaluation of TaiHao Breast Ultrasound Diagnosis Software

TaiHao Medical Inc.16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer Breast Diseases

Interventions

Reader Group X - Session 1DIAGNOSTIC_TEST

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 1DIAGNOSTIC_TEST

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 2DIAGNOSTIC_TEST

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.

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Arlington Innovation Center: Health Research - Virginia Tech

Arlington, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: 10 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 10 weeks

Data from ClinicalTrials.gov

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