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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called Mirai, which uses mammograms to predict breast cancer risk more accurately. It aims to determine if women identified as high risk by Mirai guidelines benefit from additional MRI scans (Breast MRI) compared to those identified by current methods. The trial will also examine how these new guidelines affect different racial and ethnic groups. Women identified as high risk based on Mirai or traditional guidelines and who have had screening mammograms might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance breast cancer risk assessment for diverse populations.

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 prior data suggests that the Mirai model is safe for breast cancer screening?

Research has shown that breast MRI (magnetic resonance imaging) is a well-known tool for screening women at high risk for breast cancer. Studies have found that MRI is safe and can effectively complement regular mammograms for these women. It uses strong magnets and radio waves to create detailed pictures of the breast, aiding in more accurate cancer detection.

In a large study, adding MRI to mammograms improved cancer detection in high-risk women. The American Cancer Society recommends an annual breast MRI for certain high-risk groups. While MRIs are generally well-tolerated, some individuals might feel uncomfortable due to the machine's small space or noise. However, these are not serious safety concerns.

Overall, breast MRI is considered safe and effective for screening, especially for those at high risk for breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of MRI screening specifically for people at high risk of breast cancer, identified through two different models, MIRAI and Tyrer-Cuzick. Unlike traditional mammograms, which are the standard for breast cancer screening, an MRI can provide more detailed images, potentially catching cancers that might be missed otherwise. This is particularly important for high-risk patients, where early detection can significantly impact treatment outcomes. By comparing the effectiveness of MRI in individuals identified as high-risk by these two different models, researchers hope to improve how we screen for breast cancer and tailor it more effectively to those who need it most.

What evidence suggests that the Mirai model is effective for high-risk breast cancer detection?

Research shows that Breast MRI effectively detects early breast cancer, especially in women at high risk. Studies have found that MRI can identify small growths that mammograms might miss. For women with very dense breast tissue, MRI screening outperforms mammograms alone. In this trial, high-risk participants will be assessed using different models. The MIRAI model will identify one group as high risk, while the Tyrer-Cuzick model will identify another. A large study found that combining MRI and mammograms improves cancer detection. MRI screening is associated with finding more early-stage cancers, which is crucial for better health outcomes. ^{1 4 6 7 8}

Who Is on the Research Team?

Mohammed Shazeeb, PhD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38142230/

Outcomes of High-Risk Breast MRI Screening in Women ... High-risk screening breast MRI was effective at detecting early breast cancer and associated with favorable outcomes.

2. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/breast-mri

Breast Magnetic Resonance Imaging (MRI) Research has found that MRI can locate some small breast lesions sometimes missed by mammography. It can also help detect breast cancer in women with breast ...

3. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-024-01653-4

The paradox of MRI for breast cancer screening: high-risk and ... In 2019, the results of the “DENSE” RCT were published in favour of breast MRI screening of women with extremely dense breasts compared to ...

4. breastsurgeons.org breastsurgeons.org/docs/statements/Consensus-Guideline-on-Diagnostic-and-Screening-Magnetic-Resonance-Imaging-of-the-Breast.pdf

Diagnostic and Screening Magnetic Resonance Imaging of ... In a 2015 pooled analysis of women at high risk for breast cancer, Phi et al reported that MRI and mammography increased screening sensitivity of cancer.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8178936/

Magnetic Resonance Imaging in Screening of Breast Cancer In this group, MR imaging has been found to increase detection of early-stage cancer compared with mammography (14 per 1000 vs 5 per 1000 cancers; P<.0003).

6. mayoclinic.org mayoclinic.org/tests-procedures/breast-mri/about/pac-20384809

Breast MRI A breast MRI makes pictures of the inside of the breast. It uses powerful magnets, radio waves and a computer to make images with a lot of detail.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4014797/

Magnetic resonance imaging in breast cancer: A literature ... MRI has an important role in screening high-risk patients. The American Cancer Society Guidelines for the Early Detection of Cancer advices annual breast MRI ...

8. radiologyinfo.org radiologyinfo.org/en/info/breastmr

Breast MRI MRI as an addition to mammography has been shown to be useful in evaluating women at high risk for breast cancer. MRI can successfully image the dense breast ...