Evaluation of TaiHao Breast Ultrasound Diagnosis Software

October 11, 2022 updated by: TaiHao Medical Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Arlington, Virginia, United States, 22203
        • Arlington Innovation Center: Health Research - Virginia Tech

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional 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
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
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.
Active Comparator: 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.
Diagnostic test: 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.
Active Comparator: 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.
Diagnostic test: 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.
Active Comparator: 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
10 weeks
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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TaiHao Medical Inc.

Collaborators

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

Investigators

  • Study Director: Shih Chung Lo, Ph.D., Arlington Innovation Center: Health Research - Virginia Tech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2020

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TaiHao BR-USCAD VT 20-249

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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