Clinical trial · Interventional
Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound
Multi-Reader Multi-Case, Cross-Over, Retrospective Study to Evaluate the Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound
- 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)
This is a retrospective, fully-crossed, multi-reader, multi-case (MRMC) study to evaluate the effectiveness of 'CadAI-B Dx' (CadAI-B) for decision support in breast ultrasound. The study compares the diagnostic performance of readers interpreting breast ultrasound images with and without the aid of CadAI-B. A total of 797 patient cases will be included, comprising 350 cases with a confirmed diagnosis of malignancy and 447 cases with a confirmed benign diagnosis. Sixteen readers will participate in the study to evaluate the device.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CadAI-B Dx | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- CadAI- Dx(AI) Unaided Reading
- description
- Readers evaluate each ultrasound image without access to AI assistance. Readers use only the provided radiological images and their professional clinical expertise to determine their final diagnosis and relevant findings
- type
- EXPERIMENTAL
- label
- CadAI-DX (AI)-aided Reading
- description
- Readers have access to CadAI-B's decision-support outputs, which include a pixel-level heatmap (CadAI-Map), auto-segmented lesion boundary, BI-RADS lexicon descriptors, a suggested malignancy probability score (CadAI-Score), and BI-RADS category.
- interventionNames
- Device: CadAI-B Dx
Primary outcomes (1)
- measure
- Area Under the Localization Receiver Operating Characteristic (LROC) Curve (AULROC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 22 years or older at the time of the breast ultrasound examination. 2. Standard B-mode breast ultrasound images available for analysis. 3. Lesions must have a confirmed diagnosis based on one of the following reference standards: 3-1. Malignant Cases: Diagnosis of breast cancer confirmed through biopsy or surgery. 3-2. Benign Cases: Confirmed as benign through biopsy or surgical excision, or confirmed as having no evidence of malignancy for at least 2 years of follow-up. Exclusion Criteria: 1. mages containing modes other than standard B-mode ultrasound, such as Doppler, elastography, or other annotations/overlays. 2. Patients who have breast implant(s). 3. Patients suffering from significant breast trauma or mastitis at the time of the breast ultrasound examination. 4. Images of post-surgical resection sites. 5. Images where multiple lesions are present within a single 2D ultrasound image
References
Publications (0)
Data not yet available