MRI Screening for High-Risk Breast Cancer Detection

Overseen By Sara Schiller, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Under 40, Pregnant, Male, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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. 1. Conduct a prospective study where patients who are identified as high risk by Mirai guidelines are invited to receive supplemental MRI within 12 months. 2. 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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Breast MRI for high-risk breast cancer detection?

Research shows that MRI is more sensitive than mammography in detecting breast cancer, especially in high-risk women, and can find smaller cancers with less lymph node involvement. This means MRI can catch cancer earlier, which may improve survival rates. ^{1 2 3 4 5}

Is breast MRI generally safe for humans?

Breast MRI is generally considered safe, but it can lead to false-positive results, which might require additional imaging or biopsies that turn out to be unnecessary. ^{3 6 7 8 9}

How is the treatment Breast MRI different from other treatments for high-risk breast cancer detection?

Breast MRI is unique because it uses magnetic fields and radio waves to create detailed images of the breast, making it highly sensitive in detecting breast cancer, especially in high-risk women. Unlike traditional mammograms, MRI can find cancers that are not visible on mammograms, but it is more expensive and may lead to more false positives. ^{1 2 7 10 11}

Research Team

Mohammed Shazeeb, PhD

Principal Investigator

UMass Chan Medical School

Eligibility Criteria

This trial is for women over 40 identified as high risk for breast cancer using the Mirai model or traditional guidelines. They must have had a mammogram at Umass sites with results in the EHR and be willing to undergo an MRI. Pregnant women, those under 40, men, and anyone with poor quality mammogram images are excluded.

Inclusion Criteria

If my MRI shows something unusual, I will need a biopsy to confirm the diagnosis.

Reports of all follow up screening and diagnostic studies documented on PACS

I am a woman over 40 and considered high risk for breast cancer.

Exclusion Criteria

I am a man diagnosed with breast cancer.

Pregnant patients because they do not routinely receive screening mammogram

Your breast cancer screening X-ray has unclear or distorted images.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prospective Study

Patients identified as high risk by Mirai guidelines are invited to receive supplemental MRI

12 months

Outcome Comparison

Compare cancer outcomes between patients identified as high risk by Mirai and those identified by existing guidelines

1.5 years

Follow-up

Participants are monitored for cancer development compared to the general population

1.5 years

Treatment Details

Interventions

• Breast MRI

Trial Overview The MIRAI-MRI study is testing if screening MRIs based on high-risk assessments from a new AI model called Mirai can better detect breast cancer compared to current standards. It involves comparing outcomes of patients identified by Mirai against those by traditional methods.

Participant Groups

Group I: High Risk Participants--MIRAI Experimental Treatment 2 Interventions

Patients who are deemed high risk on standard breast screening mammogram by the MIRAI model

Group II: High Risk Participants--non-MIRAI Active Control 1 Intervention

Patients who are deemed high risk by Tyrer-Cuzick model but not MIRAI

Breast MRI is already approved in United States, European Union for the following indications:

Approved in United States as Breast MRI for:

• Breast cancer screening for high-risk individuals
• Supplemental screening for breast cancer detection

Approved in European Union as Breast MRI for:

• Breast cancer screening for high-risk individuals
• Supplemental screening for breast cancer detection

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Findings from Research

Contrast-enhanced MRI has proven valuable in diagnosing breast cancer, particularly in women with abnormalities detected by mammograms, and can identify multifocal cancers that mammograms may miss.

There is growing interest in using MRI for screening high-risk women for breast cancer, with ongoing studies showing promising preliminary results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of magnetic resonance imaging to early detection of breast cancer. Schnall, MD.[2019]

A study involving 348,955 women found that 82.9% of screening MRIs were performed on women who did not meet professional guidelines for supplemental screening, indicating a significant overuse of MRI in low- and average-risk populations.

Among women with less than 20% lifetime breast cancer risk, those with extremely dense breasts or certain benign conditions showed much higher rates of MRI utilization, suggesting that factors other than established risk guidelines are influencing screening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of breast cancer screening with magnetic resonance imaging in community practice. Hill, DA., Haas, JS., Wellman, R., et al.[2019]

MRI screening for high-risk women can significantly increase the detection of breast cancers, particularly identifying cancers before they spread to lymph nodes.

While MRI offers benefits in cancer detection, it also carries risks of false positives, which may result in unnecessary additional imaging or benign biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening MRI for women at high risk for breast cancer. Lehman, CD.[2019]

Breast MRI screening is effective in detecting early breast cancer, but its impact on reducing breast cancer mortality still needs to be proven.

The ethical implications of MRI screening, including the risks and benefits that must be communicated to participants, are crucial for policymakers in deciding how to allocate healthcare resources for this screening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethical issues in contrast-enhanced magnetic resonance imaging screening for breast cancer. Plevritis, SK., Ikeda, DM.[2019]

MRI screening is recommended as the most sensitive diagnostic tool for women at high risk of breast cancer, allowing for earlier detection of smaller tumors and reducing the incidence of interval cancers, which can improve survival rates.

Despite its advantages, there are some drawbacks to MRI screening that may limit its applicability, and current guidelines do not fully agree on recommendations for certain patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening in patients with increased risk of breast cancer (part 1): pros and cons of MRI screening. Alonso Roca, S., Delgado Laguna, AB., Arantzeta Lexarreta, J., et al.[2021]

In a study of 9,208 women aged 40 to 64, those who underwent breast MRI experienced significantly more downstream medical events (39 additional mammary events and 19.6 additional extramammary events per 100 women) compared to those who had mammograms.

Breast MRI also resulted in higher overall healthcare costs, with an increase of $1,404 per woman in total spending and $31 more in out-of-pocket expenses, suggesting that while MRI may provide more information, it also leads to more procedures and costs that may not always be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Downstream Mammary and Extramammary Cascade Services and Spending Following Screening Breast Magnetic Resonance Imaging vs Mammography Among Commercially Insured Women. Ganguli, I., Keating, NL., Thakore, N., et al.[2022]

A retrospective analysis of 494 MRI-guided breast biopsies from 440 patients over 16 years showed that 73% of the biopsies were benign and 27% were malignant, indicating a consistent distribution of diagnoses during this period.

There was a significant increase in the detection of benign papillary and sclerosing lesions, rising from 13% to 31% between the earlier (2004-2011) and later (2012-2019) years, suggesting a shift in the types of benign conditions identified through MRI-guided biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sixteen-Year Institutional Review of Magnetic Resonance Imaging-Guided Breast Biopsies: Trends in Histologic Diagnoses With Radiologic Correlation. Motanagh, SA., Dwan, D., Azizgolshani, N., et al.[2023]

In a study of 320 high-risk women who underwent 757 breast MRI procedures from 2007 to 2013, the number of false-positive findings (harms) decreased with each subsequent MRI, indicating improved screening efficiency over time.

Despite the initial higher rate of false positives, breast MRI continued to successfully detect cancer, with a total of 6 malignancies identified from 75 biopsy procedures, demonstrating its ongoing utility as a screening tool for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Related Changes in Yield and Harms of Screening Breast Magnetic Resonance Imaging. Pederson, HJ., O'Rourke, C., Lyons, J., et al.[2015]

Breast MRI is particularly beneficial for high-risk patients, those with a new breast cancer diagnosis, and for monitoring treatment responses, showing high sensitivity for earlier and more accurate cancer detection.

Despite its advantages, breast MRI has limitations such as high costs and modest specificity, which can lead to false positives, highlighting the need for careful application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast MRI for cancer detection and characterization: a review of evidence-based clinical applications. DeMartini, W., Lehman, C., Partridge, S.[2008]

In a study of 177 MRI-guided breast biopsies from 152 patients, 71% of the lesions were found to be benign, highlighting the challenge of distinguishing between benign and malignant lesions based solely on MRI characteristics.

MRI can detect breast cancers that other imaging methods might miss, but it also identifies many benign lesions, indicating that biopsy is essential for accurate diagnosis due to overlapping features between benign and malignant lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathologic Findings of Breast Lesions Detected on Magnetic Resonance Imaging. Jabbar, SB., Lynch, B., Seiler, S., et al.[2017]

Combining MRI with annual mammography significantly improves the ability to rule out cancerous lesions in women at very high risk for breast cancer, with a negative likelihood ratio of 0.14 compared to 0.70 for mammography alone.

The study analyzed 11 prospective studies involving various patient populations, indicating that the dual screening method is more effective in detecting potential breast cancer in high-risk women, particularly those with BRCA1 or BRCA2 mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: using magnetic resonance imaging to screen women at high risk for breast cancer. Warner, E., Messersmith, H., Causer, P., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Application of magnetic resonance imaging to early detection of breast cancer. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Utilization of breast cancer screening with magnetic resonance imaging in community practice. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Screening MRI for women at high risk for breast cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Ethical issues in contrast-enhanced magnetic resonance imaging screening for breast cancer. [2019]

5. Spain pubmed.ncbi.nlm.nih.gov

Screening in patients with increased risk of breast cancer (part 1): pros and cons of MRI screening. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Downstream Mammary and Extramammary Cascade Services and Spending Following Screening Breast Magnetic Resonance Imaging vs Mammography Among Commercially Insured Women. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Sixteen-Year Institutional Review of Magnetic Resonance Imaging-Guided Breast Biopsies: Trends in Histologic Diagnoses With Radiologic Correlation. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Time-Related Changes in Yield and Harms of Screening Breast Magnetic Resonance Imaging. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Breast MRI for cancer detection and characterization: a review of evidence-based clinical applications. [2008]

10. United States pubmed.ncbi.nlm.nih.gov

Pathologic Findings of Breast Lesions Detected on Magnetic Resonance Imaging. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Systematic review: using magnetic resonance imaging to screen women at high risk for breast cancer. [2022]