Evaluation of TaiHao Breast Ultrasound Diagnosis Software

Breast Cancer Clinical Trial

Official title:

Evaluation of TaiHao Breast Ultrasound Diagnosis Software

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551105
• Other study ID #: TaiHao BR-USCAD VT 20-249
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: October 2022
• Source: TaiHao Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Arlington Innovation Center: Health Research - Virginia Tech	Arlington	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
TaiHao Medical Inc.	Columbia University, Taipei Veterans General Hospital, Taiwan, Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	10 weeks
Secondary	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.	10 weeks