NCT05792475

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

November 27, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

February 10, 2023

Last Update Submit

November 22, 2023

Conditions

Breast CancerBreast Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 week

Secondary Outcomes (1)

  • 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

Study Arms (1)

Define Standard of Truth (SOT) by 3 experts

OTHER

Three experts A, B, and C independently define standard of truth (SOT) about 108 cases.

Diagnostic Test: Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software

Interventions

Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic SoftwareDIAGNOSTIC_TEST

TaiHao Breast Cancer Diagnostic Software independently define standard of truth (SOT) about108 cases.

Define Standard of Truth (SOT) by 3 experts

Eligibility Criteria

Age20 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TaiHao Medical Inc

Taipei, 10663, Taiwan

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2023

First Posted

March 31, 2023

Study Start

January 30, 2023

Primary Completion

June 14, 2023

Study Completion

November 30, 2023

Last Updated

November 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)