Back to results

Evaluation of TaiHao Breast Ultrasound Diagnosis Software

Primary Purpose

Breast Cancer, Breast Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Reader Group X - Session 1

Reader Group Y - Session 1

Reader Group X - Session 2

Reader Group Y - Session 2

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arlington Innovation Center: Health Research - Virginia Tech

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

First session: manual review first and then review with CADx

First session: review with CADx first and then manual review

Second session: manual review first and then review with CADx

Second session: review with CADx first and then manual review

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04551105

First Posted

September 2, 2020

Last Updated

October 11, 2022

Sponsor

TaiHao Medical Inc.

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04551105

Brief Title

Evaluation of TaiHao Breast Ultrasound Diagnosis Software

Official Title

Evaluation of TaiHao Breast Ultrasound Diagnosis Software

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

August 15, 2020 (Actual)

Primary Completion Date

November 1, 2020 (Actual)

Study Completion Date

November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TaiHao Medical Inc.

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Breast Diseases

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

First session: manual review first and then review with CADx

Arm Type

Active Comparator

Arm Description

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.

Arm Title

First session: review with CADx first and then manual review

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Second session: manual review first and then review with CADx

Arm Type

Active Comparator

Arm Description

Arm Title

Second session: review with CADx first and then manual review

Arm Type

Active Comparator

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Reader Group X - Session 1

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Reader Group Y - Session 1

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Reader Group X - Session 2

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Reader Group Y - Session 2

Intervention Description

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 Outcome Measure Information:

Title

Comparing the Area Under the LROC Curve

Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

10 weeks

Title

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

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shih Chung Lo, Ph.D.

Organizational Affiliation

Arlington Innovation Center: Health Research - Virginia Tech

Official's Role

Study Director

Facility Information:

Facility Name

Arlington Innovation Center: Health Research - Virginia Tech

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22203

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of TaiHao Breast Ultrasound Diagnosis Software

We'll reach out to this number within 24 hrs