Clinical trial · Interventional
KNUCH CadAI-B-1(KCB-1)
Multinational Clinical Trial of Real-time Artificial Intelligence System (CadAI-B) for Breast Ultrasound: Prospective Clinical Validation Study
- 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 CadAI-B (Computer Aided Design Artificial Intelligence-Breast) system is a real-time AI diagnostic tool for breast ultrasound. It integrates with ultrasound devices to detect suspicious lesions, providing size, BI-RADS, and malignancy probability. After installation and user training, the system displays real-time breast conditions and automatically analyzes lesions when a freeze frame is set, showing results in seconds. This study will assess CadAI-B\'s accuracy and reliability by comparing its findings with biopsy results.
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CadAI-B | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CadAI-B intervention group
- description
- Participants in this arm will receive the CadAI-B system for the detection of lesions. The AI-based tool will assist healthcare professionals in identifying lesions through enhanced image analysis.
- interventionNames
- Diagnostic Test: CadAI-B
Primary outcomes (1)
- measure
- Lesion and Per-patient Diagnostic Performance
- timeFrame
- At the end of the trial, up to 6 months
- description
- AUC (Area Under the Curve), Sensitivity, Specificity
Secondary outcomes (1)
- measure
- Lesion and Per-patient Detection Performance
- timeFrame
- At the end of the trial, up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 20 years or older * Individuals scheduled to undergo breast ultrasound for diagnostic evaluation * Patients whose Ground Truth can be determined through biopsy, surgery, or follow-up Exclusion Criteria: * Images containing artifacts that may affect the interpretation * Presence of breast implants * Significant breast trauma or mastitis at the time of the breast ultrasound that could cause distortion in image interpretation * History of surgery or chemotherapy
References
Publications (0)
Data not yet available