Breast CancerNCT05792475
Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes
A study testing Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software in people with Breast Cancer and Breast Diseases, run by TaiHao Medical Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 69 years, women only
- Conditions the study is for
- Breast Cancer, Breast Diseases
- What is being tested?
- Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jan 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 20 to 69, including those with and without breast lesions.
Who cannot join
- Have a pacemaker or prosthetic valve.
- A post-surgery follow-up patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of TaiHao Breast Ultrasound Diagnosis Software (Plan for Partial Modification of Diagnostic Performance)
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.
- Conditions
- Breast Cancer, Breast Diseases
- Being tested
- Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Define Standard of Truth (SOT) by 3 experts | Other | Three experts A, B, and C independently define standard of truth (SOT) about 108 cases. Receives: Diagnostic Test: Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start30 Jan 2023
- Primary completion14 Jun 2023
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiHao Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792475
- Sponsor's protocol ID
- TaiHao TVGH2020-07-006AC#1
- Status last verified
- Mar 2023
- First submitted
- 10 Feb 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TaiHao Breast Ultrasound Diagnosis Software (Plan for Partial Modification of Diagnostic Performance)
- ClinicalTrials.gov ID
- NCT05792475
- Acronym / sponsor ID
- TaiHao TVGH2020-07-006AC#1
- Conditions
- Breast Cancer, Breast Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (actual)
- Lead sponsor
- TaiHao Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Define Standard of Truth (SOT) by 3 experts | Other | Diagnostic Test: Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic SoftwareThree experts A, B, and C independently define standard of truth (SOT) about 108 cases. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients aged 20 to 69, including those with and without breast lesions.
Key exclusion criteria (2 listed)
- Have a pacemaker or prosthetic valve.
- A post-surgery follow-up patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic SoftwareTaiHao Breast Cancer Diagnostic Software independently define standard of truth (SOT) about108 cases. | Diagnostic test | Define Standard of Truth (SOT) by 3 experts |
Primary outcome
The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance.
Time frame: 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.
1 secondary outcome
The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance.
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software in people with Breast Cancer and Breast Diseases, run by TaiHao Medical Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.