Clinical trial · Interventional
Evaluation of TaiHao Breast Ultrasound Diagnosis Software
NCT04551105CI-TRIAL-00061893completedN/AResults postedClinicalTrials.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)
The BR-USCAD DS Module is a computer-assisted detection and diagnosis software based on a deep learning algorithm. This retrospective, fully-crossed, multi-reader, multi-case (MRMC) study aims to compare the performances of readers without and with the aid of the Breast Ultrasound Image Reviewed with Assistance of Computer-Assisted Detection and Diagnosis System (BR-USCAD DS) in interpreting breast ultrasound images of lesions.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reader Group X - Session 1 | Diagnostic Test | — | UNRESOLVED |
| Reader Group X - Session 2 | Diagnostic Test | — | UNRESOLVED |
| Reader Group Y - Session 1 | Diagnostic Test | — | UNRESOLVED |
| Reader Group Y - Session 2 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- First session: manual review first and then review with CADx
- description
- Reader Group X interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system.
- interventionNames
- Diagnostic Test: Reader Group X - Session 1
- type
- ACTIVE_COMPARATOR
- label
- First session: review with CADx first and then manual review
- description
- Reader Group Y interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI.
- interventionNames
- Diagnostic Test: Reader Group Y - Session 1
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * B-mode breast ultrasound image * Female, age 21 or older * Breast lesion images acquired before a biopsy or surgery - these images were retrospectively collected with histology report. * Non-biopsied benign lesions with negative follow-up for a minimum of 24 months * At least two orthogonal views of a lesion Exclusion Criteria: * Breast lesion images acquired after biopsy or surgery. * Any breast surgeries or interventional procedures in the 12 months prior to ultrasound imaging * Case demonstrating administrative or technical errors * Multiple lesions in one 2-D ultrasound image * Breast ultrasound images with Doppler, elastography, or other overlays present * Case with less than 2-year follow-up and without biopsy confirmation
References
Publications (0)
Data not yet available
No reference posted for this study.