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Completed

NCT Number: NCT04551105

Evaluation of TaiHao Breast Ultrasound Diagnosis Software

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arlington Innovation Center: Health Research - Virginia Tech

Arlington, Virginia, 22203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reader Group X - Session 1

Diagnostic 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 1

Diagnostic 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 2

Diagnostic 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.

Reader Group Y - Session 2

Diagnostic Test

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.

Primary outcomes

  1. Comparing the Area Under the LROC Curve

    Time frame: 10 weeks

    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.

Secondary outcomes

  1. The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.

    Time frame: 10 weeks

    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.

  2. The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.

    Time frame: 10 weeks

    The mean sensitivity, specificity, PPV, and NPV of 16 readers were calculated and compared between the aided and unaided sessions using McNemar's test.

Sponsors and collaborators

Lead sponsor

TaiHao Medical Inc.

Industry

Collaborators

  • Columbia University
  • Taipei Veterans General Hospital, Taiwan
  • Virginia Polytechnic Institute and State University

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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