Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Breast Diseases
• Interventions: Diagnostic Test: Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software

• Registration Number: NCT05792475
• Lead Sponsor: TaiHao Medical Inc.

Brief Summary

A standard of truth "SOT" is determined based on the interpretation results of the case data by interpretation experts, and the SOT is compared with the detection results of this program's function for detecting suspected breast cancer (CADe function). Estimate the detectability of the CADe function by comparing.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-30
• Study First Submitted: 2023-02-10
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-03-31
• Primary Completion: 2023-06-14
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-27
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• Female patients aged 20 to 69, including those with and without breast lesions.

Exclusion Criteria

• Have a pacemaker or prosthetic valve.
• A post-surgery follow-up patient.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Define Standard of Truth (SOT) by 3 experts	Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software	Three experts A, B, and C independently define standard of truth (SOT) about 108 cases.

Primary Outcome Measures

Name	Time	Method
The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance.	1 week	The average of 4 types of machines (Canon Aplio i800, GE Logiq E10, GE Invenia ABUS, Fuji ARIETTA 60) performance compared to Siemens performance which was submitted to PMDA last time.

Secondary Outcome Measures

Name	Time	Method
The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance.	1 week	Each machine (Canon Aplio i800, GE Logiq E10, GE Invenia ABUS, Fuji ARIETTA 60) performance compared to Siemens performance which was submitted to PMDA last time.

Trial Locations

Locations (1)

TaiHao Medical Inc; 🇨🇳 Taipei, Taiwan