Clinical trial · Interventional
Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes
Evaluation of TaiHao Breast Ultrasound Diagnosis Software (Plan for Partial Modification of Diagnostic Performance)
NCT05792475CI-TRIAL-00071724unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Define Standard of Truth (SOT) by 3 experts
- description
- Three experts A, B, and C independently define standard of truth (SOT) about 108 cases.
- interventionNames
- Diagnostic Test: Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software
Primary outcomes (1)
- measure
- The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance.
- timeFrame
- 1 week
- 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.
Secondary outcomes (1)
- measure
- The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.