Evaluation of TaiHao Breast Ultrasound Diagnosis Software

NCT04551105 | Completed Results DMC FDA Device

• 1 other identifier: TaiHao BR-USCAD VT 20-249
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks

Secondary Outcomes (2)

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

  10 weeks

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

  10 weeks

Study Arms (4)

First session: manual review first and then review with CADx

ACTIVE COMPARATOR

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

First session: review with CADx first and then manual review

ACTIVE COMPARATOR

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

Second session: manual review first and then review with CADx

ACTIVE COMPARATOR

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

Second session: review with CADx first and then manual review

ACTIVE COMPARATOR

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

Interventions

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.

First session: manual review first and then review with CADx

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.

First session: review with CADx first and then manual review

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.

Second session: manual review first and then review with CADx

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.

Second session: review with CADx first and then manual review

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TaiHao Medical Inc.: lead
• Columbia University: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Arlington Innovation Center: Health Research - Virginia Tech

Arlington, Virginia, 22203, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director of Clinical Trials
• Organization: Virginia Tech

dcben0@gmail.com

+1 (301) 820-5225

Study Officials

• Shih Chung Lo, Ph.D.

  Arlington Innovation Center: Health Research - Virginia Tech

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 16, 2020
• Study Start: August 15, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 2, 2022
• Results First Posted: November 2, 2022

Record last verified: 2022-10

Locations

US (1)