Breast CancerNCT05968157
MIRAI-MRI: Comparing Screening MRI for Patients at High Risk for Breast Cancer Identified by Mirai and Tyrer-Cuzick
A study testing Breast MRI and MIRAI in people with Breast Cancer, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast MRI and MIRAI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2024to 1 Feb 2026
- Phase
- Interventional
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- These patients will be invited to receive a supplemental MRI examination currently considered the most sensitive test for breast cancer detection.
- Any positive diagnosis on MRI will be followed by biopsy to confirm 'truth" of diagnosis.
- To be selected, a given record must include the following:
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- A report of a routine screening mammogram or diagnostic mammogram, and availability of the DICOM images from that report with the PACS system.
- Reports of all follow up screening and diagnostic studies documented on PACS.
- Some may have interventional procedures (as long as all of these are done at one of Umass sites) and documentation of these biopsy results in the hospitals EHR.
Who cannot join
- Under age 40. Women under 40 years are not routinely xrayed with a mammogram.
- Xray breast cancer screening imaging study that has artifacts, corruption, or other image quality degradation.
- Pregnant patients because they do not routinely receive screening mammogram
- Adult male patients with breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School
Worcester, Massachusetts, 01655
About this study
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.
Read more
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.
- Conduct a prospective study where patients who are identified as high risk by Mirai guidelines are invited to receive supplemental MRI within 12 months.
- Compare cancer outcomes between patients only identified as high risk by Mirai and patients identified as high risk by existing guidelines The secondary aim is to study the impact of new guidelines by race and ethnicity, to ensure equitable improvements in cancer screening.
- Conditions
- Breast Cancer
- Being tested
- Breast MRI, MIRAI
- Keywords
- Breast Cancer, Screening, Artificial Intelligence
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast MRIDiagnostic test
Supplemental MRI (in addition to standard of care MRI).
MIRAIDevice
Artificial intelligence software
| Study group | Role | What they receive |
|---|---|---|
| High Risk Participants--MIRAI | Experimental | Patients who are deemed high risk on standard breast screening mammogram by the MIRAI model Receives: Diagnostic Test: Breast MRI; Device: MIRAI |
| High Risk Participants--non-MIRAI | Active comparator | Patients who are deemed high risk by Tyrer-Cuzick model but not MIRAI Receives: Diagnostic Test: Breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 years (duration of patient recruitment and outcome data collection)
Secondary outcomes (1)
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.
Measured: 1.5 years (duration of patient recruitment and outcome data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start4 Feb 2024
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
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.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Mohammad Salman Shazeeb, University of Massachusetts, Worcester
- Investigators
- Mohammed Salman Shazeeb, PhD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968157
- Sponsor's protocol ID
- STUDY000000485
- Other IDs
- MIT_s5822, SPEC-22-015
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRAI-MRI: Comparing Screening MRI for Patients at High Risk for Breast Cancer Identified by Mirai and Tyrer-Cuzick
- ClinicalTrials.gov ID
- NCT05968157
- Acronym / sponsor ID
- STUDY000000485
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Screening, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Breast Cancer Research Foundation
- Study start
- 4 Feb 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 1 Aug 2023 (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.
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.
- Conduct a prospective study where patients who are identified as high risk by Mirai guidelines are invited to receive supplemental MRI within 12 months.
- Compare cancer outcomes between patients only identified as high risk by Mirai and patients identified as high risk by existing guidelines The secondary aim is to study the impact of new guidelines by race and ethnicity, to ensure equitable improvements in cancer screening.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Risk Participants--MIRAI | Experimental | Diagnostic Test: Breast MRI, Device: MIRAIPatients who are deemed high risk on standard breast screening mammogram by the MIRAI model |
| High Risk Participants--non-MIRAI | Active comparator | Diagnostic Test: Breast MRIPatients who are deemed high risk by Tyrer-Cuzick model but not MIRAI |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (4 listed)
- Under age 40. Women under 40 years are not routinely xrayed with a mammogram.
- Xray breast cancer screening imaging study that has artifacts, corruption, or other image quality degradation.
- Pregnant patients because they do not routinely receive screening mammogram
- Adult male patients with breast cancer
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 |
|---|---|---|
| Breast MRISupplemental MRI (in addition to standard of care MRI). | Diagnostic test | High Risk Participants--MIRAI, High Risk Participants--non-MIRAI |
| MIRAIArtificial intelligence software | Device | High Risk Participants--MIRAI |
Primary outcome
CDR Mirai Assessment versus CDR Traditional High Risk Screening
Time frame: 1.5 years (duration of patient recruitment and outcome data collection)
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 secondary outcome
Cancer development within study population versus general population of average risk women
Time frame: 1.5 years (duration of patient recruitment and outcome data collection)
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 8 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Mohammed Salman Shazeeb, PhD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast MRI and MIRAI in people with Breast Cancer, run by University of Massachusetts, Worcester at 1 site in United States.
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 9 inclusion and 4 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
CDR Mirai Assessment versus CDR Traditional High Risk Screening (time frame: 1.5 years (duration of patient recruitment and outcome data collection)). 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 8 Sep 2026.