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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TaiHao Medical Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Columbia University
Virginia Polytechnic Institute and State University
Taipei Veterans General Hospital, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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