Breast Cancer Clinical Trial

Evaluation of TaiHao Breast Ultrasound Diagnosis Software

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.

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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 12 months
At least two orthogonal views of a lesion
All the cases in this study are collected from at least 3 different ultrasound apparatuses

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

16

Study ID:

NCT04551105

Recruitment Status:

Active, not recruiting

Sponsor:

TaiHao Medical Inc.

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There is 1 Location for this study

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Arlington Innovation Center: Health Research - Virginia Tech
Arlington Virginia, 22203, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

16

Study ID:

NCT04551105

Recruitment Status:

Active, not recruiting

Sponsor:


TaiHao Medical Inc.

How clear is this clinincal trial information?

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