Back to resultsEvaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes
Primary Purpose
Breast Cancer, Breast Diseases
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- TaiHao Medical Inc
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Define Standard of Truth (SOT) by 3 experts
Arm Description
Three experts A, B, and C independently define standard of truth (SOT) about 108 cases.
Outcomes
Primary Outcome Measures
The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance.
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
The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05792475
Brief Title
Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes
Official Title
Evaluation of TaiHao Breast Ultrasound Diagnosis Software (Plan for Partial Modification of Diagnostic Performance)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TaiHao Medical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Define Standard of Truth (SOT) by 3 experts
Arm Type
Other
Arm Description
Three experts A, B, and C independently define standard of truth (SOT) about 108 cases.
Intervention Type
Diagnostic Test
Intervention Name(s)
Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software
Intervention Description
TaiHao Breast Cancer Diagnostic Software independently define standard of truth (SOT) about108 cases.
Primary Outcome Measure Information:
Title
The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance.
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance.
Description
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.
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
TaiHao Medical Inc
City
Taipei
ZIP/Postal Code
10663
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes
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