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NCT07298252: CARE-MMG-MRMC
Diagnostic Accuracy of Carebot AI MMG in Mammography Screening: Multicenter MRMC Study
trial testing Carebot AI MMG software analysis in Breast Neoplasms in 222 participants. Completed in 3 November 2025.
3 November 2025
Quick facts
| Lead sponsor | Carebot s.r.o. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 222 |
| Start date | 1 January 2025 |
| Primary completion | 3 November 2025 |
| Estimated completion | 3 November 2025 |
| Sites | 4 locations across Slovakia, Czechia |
Drugs / interventions tested
- Carebot AI MMG software analysis
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
- Breast Cancer Detection — all drugs for Breast Cancer Detection →
- Breast Cancer - Female — all drugs for Breast Cancer - Female →
- Breast Cancer Screening — all drugs for Breast Cancer Screening →
Sponsor
Carebot s.r.o. — full company profile →
Who can join
18 and older, female only, with Breast Neoplasms or Breast Cancer Detection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates the diagnostic performance of Carebot AI MMG, an artificial intelligence (AI)-enabled medical device for evaluating mammograms. The software analyzes standard full-field digital mammography (FFDM) images and classifies each examination as having no suspicious finding ("Low Risk"), a probably benign mass ("Medium Risk"), or a suspicious malignant mass ("High Risk"). The study is retrospective and observational. It uses anonymized mammography examinations from four screening centers, without any additional imaging or contact with patients. Three experienced breast radiologists independently read the same set of cases, and their assessments are used as the human benchmark. A histopathology-based reference standard, supplemented by radiologist consensus and follow-up information for negative cases, is used to determine whether cancer is present. The main goal is to compare the AI system with human radiologists in terms of sensitivity and specificity for detecting breast cancer, and to assess whether the AI can achieve non-inferior performance at two predefined operating points: one favoring higher sensitivity and negative predictive value (rule-out) and one favoring higher specificity and positive predictive value (rule-in).
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 NCT07298252
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Carebot s.r.o. trials
Trials by the same sponsor.
- NCT06644391 — Enhancing Diagnostic Accuracy in Fracture Identification on Musculoskeletal Radiographs Using Deep Learning · completed
- NCT05963945 — Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Pra · completed
- NCT05594485 — Retrospective Study of Carebot AI CXR Performance in Preclinical Practice · completed
- NCT06428799 — Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment · completed
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 NCT07298252 (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 Carebot s.r.o.
- Last refreshed: 14 January 2026
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/NCT07298252.
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