Evaluation of TaiHao Breast Ultrasound Diagnosis Software

TaiHao Medical

Status: Completed

Conditions: Breast Cancer; Breast Diseases

Treatments: Diagnostic Test: Reader Group Y - Session 1; Diagnostic Test: Reader Group Y - Session 2; Diagnostic Test: Reader Group X - Session 2; Diagnostic Test: Reader Group X - Session 1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04551105

TaiHao BR-USCAD VT 20-249

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

First session: manual review first and then review with CADx

Active Comparator group

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.

Treatment:

Diagnostic Test: Reader Group X - Session 1

First session: review with CADx first and then manual review

Active Comparator group

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.

Treatment:

Diagnostic Test: Reader Group Y - Session 1

Second session: manual review first and then review with CADx

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Reader Group X - Session 2

Second session: review with CADx first and then manual review

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Reader Group Y - Session 2