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| ID | Type | Description | Link |
|---|---|---|---|
| MIT_s5822 | Other Grant/Funding Number | Massachusetts Institute of Technology Subaward | |
| SPEC-22-015 | Other Grant/Funding Number | Breast Cancer Research Foundation |
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| Name | Class |
|---|---|
| Massachusetts Institute of Technology | OTHER |
| Breast Cancer Research Foundation | OTHER |
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Accurate risk assessment is essential for the success of population screening programs and early detection efforts in breast cancer. Mirai is a new deep learning model based on full resolution mammograms.
Mirai is a mammography-based deep learning model designed to predict risk at multiple timepoints, leverage potentially missing risk factor information, and produce predictions that are consistent across mammography machines. Mirai was trained on a large dataset from Massachusetts General Hospital (MGH) in the United States and found to be significantly more accurate than the Tyrer-Cuzick model, a current clinical standard.
The primary aim of this study is to prospectively quantify the clinical benefit (i.e. MRI/CEM cancer detection rate) of Mirai-based guidelines and to compare them to the current standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk Participants--MIRAI | Experimental | Patients who are deemed high risk on standard breast screening mammogram by the MIRAI model |
|
| High Risk Participants--non-MIRAI | Active Comparator | Patients who are deemed high risk by Tyrer-Cuzick model but not MIRAI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast MRI | Diagnostic Test | Supplemental MRI (in addition to standard of care MRI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| CDR Mirai Assessment versus CDR Traditional High Risk Screening | Cancer detection rate from breast MRI following Mirai assessment of high risk on a screening mammogram performed less than 1 year ago and compared with established CDR in traditional high risk screening. | 1.5 years (duration of patient recruitment and outcome data collection) |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer development within study population versus general population of average risk women | On subsequent follow-up with standard of care, assessment of what percentage of the study population develops breast cancer as compared to the general population of women at average risk of breast cancer. | 1.5 years (duration of patient recruitment and outcome data collection) |
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Inclusion Criteria:
Women who were identified as high risk on the retrospective study (dating from 2017-2025) using MIRAI will be recruited and consented for the prospective study
Women over 40 years of age identified as high risk according to traditional guidelines will also be potentially eligible for this study
Following consent and enrollment in the study, a participant will subsequently receive the following:
To be selected, a given record must include the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Schiller, MPH | Contact | 7744417731 | sara.schiller1@umassmed.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mohammed Salman Shazeeb, PhD | UMass Chan Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Medical School | Recruiting | Worcester | Massachusetts | 01655 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| MIRAI | Device | Artificial intelligence software |
|
| D017437 |
| Skin and Connective Tissue Diseases |