N/A
N=16
Evaluation of TaiHao Breast Ultrasound Diagnosis Software
Breast Cancer · Breast Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04551105 ↗Enrolled (actual)
16
Serious AEs
—
Results posted
Nov 2022
Primary outcome: Primary: Comparing the Area Under the LROC Curve — 0.7786; 0.8160 probability — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reader Group X - Session 1 (Diagnostic_test); Reader Group Y - Session 1 (Diagnostic_test); Reader Group X - Session 2 (Diagnostic_test); Reader Group Y - Session 2 (Diagnostic_test)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- TaiHao Medical Inc.
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparing the Area Under the LROC Curve |
0.7786; 0.8160 | <0.05 sig |
| SECONDARY The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies. |
31.75; 18.96 | <0.05 sig |
| SECONDARY The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies. |
0.9225; 0.9353; 0.3165; 0.3611; 0.4876; 0.5056 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT04551105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.