Clinical trial · Observational
Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast
NCT06352684CI-TRIAL-00075812unknownClinicalTrials.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 purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CadAI-B for Breast | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cancer group
- description
- confirmed as a breast cancer (DCIS or invasive cancer) through the subsequent biopsy conducted within following 1 year of the ultrasound exam.
- interventionNames
- Device: CadAI-B for Breast
- label
- Benign group
- description
- Either confirmed as a benign through the subsequent biopsy conducted within following 1 year of the ultrasound exam or showing stability on more than 2 years of imaging follow-up after initial diagnosis
- interventionNames
- Device: CadAI-B for Breast
- label
- Normal group
- description
- Interpreted as BI-RADS 1 (Negative) with no cancers on the ultrasound exam
- interventionNames
- Device: CadAI-B for Breast
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Women who underwent breast US examination * Women with breast cancer (DCIS or invasive cancer) diagnosed via biopsy * Women who had been followed for more than 2 years after initial US examination Exclusion Criteria: * women who had breast implants * women who had US images containing artifacts affecting the review of images
References
Publications (0)
Data not yet available
No reference posted for this study.