--- title: Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment nct_id: NCT06428799 overall_status: COMPLETED sponsor: Carebot s.r.o. study_type: OBSERVATIONAL primary_condition: Breast Cancer countries: Czechia canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06428799.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06428799" ct_last_update_post_date: 2026-03-18 last_seen_at: "2026-05-12T06:36:58.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment **Official Title:** Evaluation of Carebot AI MMG Medical Device for Detection and Radiographic Assessment of Breast Lesions and Quantitative Analysis of Breast Density: A Multicentric, Multi-Reader Study **NCT ID:** [NCT06428799](https://clinicaltrials.gov/study/NCT06428799) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 122 - **Lead Sponsor:** Carebot s.r.o. - **Conditions:** Breast Cancer, Breast Tumor Benign - **Start Date:** 2022-01-14 - **Completion Date:** 2024-04-24 - **CT.gov Last Update:** 2026-03-18 ## Brief Summary Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2) 1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS) 2. Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS) ## Detailed Description The mammography studies were acquired from three independent sites: Site 1 (EUC Mamocentrum Brno) and Site 2 (Hospital Šumperk, a.s.) specialise in routine screening mammography, and Site 3 (Masaryk Memorial Cancer Institute) is a comprehensive oncology facility primarily dedicated to diagnostic mammography, i.e. performing additional examinations in case of a suspicious finding (recall). The ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods, and 13 and 27 years of experience with mammography image interpretation, respectively. For comparative analysis, a team of five independent radiologists with clinical experience in interpreting mammography images was established. Three of the clinicians were junior (2, 2, and 4 years of experience, respectively) without board-certification; two physicians were senior (7 and 8 years of experience, respectively), board-certified. ## Eligibility - **Minimum age:** 18 Years - **Sex:** FEMALE ``` Inclusion Criteria: * The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography. Exclusion Criteria: * The medical device cannot be used in patients with breast implants. * The medical device cannot be used in male breast examination. * The medical device cannot be used in patients under 18 years of age. ``` ## Arms - **Retrospective collection of DICOM patient files for Site 1** — A total of 60 mammographic studies were retrospectively collected from Site 1 (EUC Mamocentrum Brno). The acquisition of mammography studies from Site 1 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 14 January 2022. - **Retrospective collection of DICOM patient files for Site 2** — A total of 28 mammographic studies were retrospectively collected from Site 2 (Hospital Šumperk, a.s.). The acquisition of mammography studies from Institution 2 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 31 January 2023. - **Retrospective collection of DICOM patient files for Site 3** — A total of 34 mammographic studies were retrospectively collected from Site 3 (Masaryk Memorial Cancer Institute). The acquisition of mammography studies from Institution 3 was enabled by the amendment to the contract for the transfer of X-ray images for medical research purposes, signed on 21 February 2023, which follows the contract for the transfer of X-ray images for medical research purposes, signed on 3 January 2022. ## Interventions - **Carebot AI MMG** (DEVICE) — Carebot AI MMG is a software solution that utilizes artificial intelligence methods, specifically deep learning and computer vision algorithms, to evaluate and localize suspicious regions of potential lesions during the interpretation of digital breast x-rays as part of standard mammography screening procedures. The Carebot AI MMG medical device is not intended for use in diagnostic mammography. The Carebot AI MMG is intended for use in women over the age of 18. The predictive outputs of the Carebot AI MMG medical device are intended to aid decision-making in screening clinical practice, always in conjunction with other relevant patient information and based on the professional judgment of the examining clinician. The Carebot AI MMG is specifically designed to provide a supporting layer of analysis that helps in evaluating or prioritizing mammography images with additional patient information and the professional judgment of the examining physician. ## Primary Outcomes - **Performance Test** _(time frame: 2024)_ — A multicenter, multi-reader, retrospective study was designed to validate the clinical efficacy of the proposed Carebot AI MMG (also referred to as "DLAD"). Using a non-certified medical device, a test set of retrospectively collected mammography studies in standard projections (CC and MLO). The performance of the DLAD was evaluated against the ground truth for individual indications (breast density evaluation, breast lesion detection) using Accuracy. ## Secondary Outcomes - **Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Density Assessment** _(time frame: 2024)_ - **Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Lesion Detection** _(time frame: 2024)_ ## Locations (3) - EUC Mamocentrum Brno, Brno, Czechia - Masaryk Memorial Cancer Institute, Brno, Czechia - Hospital Šumperk, Šumperk, Czechia ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.euc mamocentrum brno|brno||czechia` — added _(2026-05-12)_ - `locations.masaryk memorial cancer institute|brno||czechia` — added _(2026-05-12)_ - `locations.hospital šumperk|šumperk||czechia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06428799.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06428799* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*