Breast CancerEMBLEDDA-MMGNCT06428799
Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment
An observational study of Breast Cancer and Breast Tumor Benign, run by Carebot s.r.o. at 3 sites in Czechia.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Tumor Benign
- What is being tested?
- Carebot AI MMG
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 3 sitesCzechia
- Study dates
- 14 Jan 2022to 24 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: A total of 122 mammography studies (488 images, the so-called "test data") were obtained from the reference sites for the evaluation by radiologists and the Carebot AI MMG v2.2. The target sites used different mammography X-ray machines: Site 1 and Site 2 used the Senographe Essential mammography machine from GE HealthCare to image patients, and Site 3 used the Selenia Dimensions mammography machine from Hologic and the MAMMOMAT Revelation mammography machine from Siemens Healthineers.
Who may be able to join
- The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
EUC Mamocentrum Brno
Brno, 60200
Masaryk Memorial Cancer Institute
Brno, 60200
Hospital Šumperk
Šumperk, 78701
About this study
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
Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2)
- Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS)
- Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS)
Read the 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.
- Conditions
- Breast Cancer, Breast Tumor Benign
- Being tested
- Carebot AI MMG
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carebot AI MMGDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Carebot AI MMG | |
| 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. Receives: Device: Carebot AI MMG | |
| 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. Receives: Device: Carebot AI MMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Test
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.
Measured: 2024
Secondary outcomes (2)
Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Density Assessment
Carebot AI MMG v2.2 classified mammography studies according to the ACR BI-RADS 5th edition, i.e. breast tissue density assessment into A/B/C/D classes. The performance of the Carebot AI MMG device was assessed relative to the ground truth and then compared with the performance of five independent radiologists with varying levels of experience (RAD 1-RAD 5). A rigorous statistical analysis was used in the BI-RADS breast density classification to evaluate the performance of each method - the proposed Carebot AI MMG v2.2 medical device and the compared radiologists in the multi-reader study. The analysis focused on key metrics including Accuracy, F1 Score (Macro-Averaged), Precision (Macro-Averaged), Recall (Macro-Averaged) and Cohen's Kappa (κ) to assess the strength of agreement. Given that all scans were evaluated by all radiologists in the comparison, a bootstrapping method that involves resampling the test data 1000 times.
Measured: 2024
Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Lesion Detection
The medical device (DLAD, Carebot AI MMG v2.2) analyzed mammography studies in standard projections (CC and MLO) and classified the presence of lesions ("present" x "absent") at the mammography study level. DLAD performance was assessed relative to the ground truth and then compared to the performance of five independent radiologists with varying levels of experience (RAD 1-RAD 5). The investigators quantified the performance of diagnostic tests based on Sensitivity, Specificity and Balanced Accuracy. The investigators further assessed the statistical significance of differences between DLAD and individual radiologists using appropriate statistical tests. To determine the reliability of the metrics examined, the investigators calculated 95% confidence intervals using Wilson scores. To evaluate the statistical significance of differences in Sensitivity and Specificity between DLAD and individual radiologists, the investigators applied McNemar's test with a continuity correction.
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start14 Jan 2022
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carebot s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428799
- Sponsor's protocol ID
- CB-MMG-01-MC
- Acronym
- EMBLEDDA-MMG
- Status last verified
- Mar 2026
- First submitted
- 7 May 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06428799
- Acronym / sponsor ID
- EMBLEDDA-MMG / CB-MMG-01-MC
- Conditions
- Breast Cancer, Breast Tumor Benign
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Carebot s.r.o.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2)
- Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective collection of DICOM patient files for Site 1 | – | Device: Carebot AI MMGA 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 | – | Device: Carebot AI MMGA 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 | – | Device: Carebot AI MMGA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- A total of 122 mammography studies (488 images, the so-called "test data") were obtained from the reference sites for the evaluation by radiologists and the Carebot AI MMG v2.2. The target sites used different mammography X-ray machines: Site 1 and Site 2 used the Senographe Essential mammography machine from GE HealthCare to image patients, and Site 3 used the Selenia Dimensions mammography machine from Hologic and the MAMMOMAT Revelation mammography machine from Siemens Healthineers.
Key inclusion criteria (1 listed)
- The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carebot AI MMGCarebot 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. | Device | Retrospective collection of DICOM patient files for Site 1, Retrospective collection of DICOM patient files for Site 2, Retrospective collection of DICOM patient files for Site 3 |
Primary outcome
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.
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Tumor Benign, run by Carebot s.r.o. at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Test (time frame: 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.