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NCT07287111
Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound
NA trial testing CadAI-B Dx in Breast Cancer in 797 participants. Completed in 24 November 2025.
7 October 2025
Quick facts
| Lead sponsor | BeamWorks Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | diagnostic |
| Enrollment | 797 |
| Start date | 30 August 2025 |
| Primary completion | 7 October 2025 |
| Estimated completion | 24 November 2025 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- CadAI-B Dx
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Breast Neoplasms — all drugs for Breast Neoplasms →
Sponsor
BeamWorks Inc.
Who can join
22 and older, female only, with Breast Cancer or Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07287111
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other BeamWorks Inc. trials
Trials by the same sponsor.
- NCT06352684 — Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07287111 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BeamWorks Inc.
- Last refreshed: 17 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07287111.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing