MRI Surveillance for High-Risk Breast Cancer

(CAPS Trial)

Overseen By Cancer Clinical Intake Office

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Active cancer treatment, Pregnancy, Pacemaker, Bilateral mastectomy, Kidney disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on using Magnetic Resonance Imaging (MRI) to detect breast cancer early in women at high risk. Participants will have MRI scans twice a year, in addition to their regular annual mammogram. This trial suits women who carry certain genetic mutations related to cancer risk or have a high calculated risk of developing breast cancer, particularly if they have undergone chest radiation before age 35 or have a family history of breast or ovarian cancer. Eligible women must be cancer-free for at least two years and not currently receiving active cancer treatment. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance early detection methods for high-risk women.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, you can continue hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, or Parp Inhibitors if you are using them as part of your treatment.

What prior data suggests that Magnetic Resonance Imaging (MRI) is safe for high-risk breast cancer surveillance?

Research shows that MRI (Magnetic Resonance Imaging) is generally safe for detecting breast cancer. It uses strong magnets and radio waves to create detailed images of the body's interior. Studies have found that combining MRI with mammograms can help detect cancer early, especially in women at high risk.

Most people tolerate MRI well. The test doesn't involve cuts or injections, but some may feel uncomfortable due to the enclosed and noisy machine. Unlike some other imaging tests, MRI doesn’t use harmful radiation.

No clear evidence indicates major risks from regular MRI use for breast cancer screening. However, experts agree that more research is needed to fully understand all the benefits and any possible risks of using MRI for screening. Currently, MRI is considered a safe option for those at higher risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRI for high-risk breast cancer surveillance because it offers more frequent and detailed imaging compared to the standard annual mammogram. Unlike traditional mammograms, MRI can provide clearer images of dense breast tissue, which is common in younger women and those at higher risk. By incorporating MRI every six months, this approach aims to catch any potential issues earlier, potentially leading to better outcomes for those at high risk.

What evidence suggests that Magnetic Resonance Imaging (MRI) is effective for early detection of high-risk breast cancer?

Research has shown that Magnetic Resonance Imaging (MRI), which participants in this trial will undergo every six months, effectively detects breast cancer early in women at high risk. Studies have found that MRI identifies more breast cancers than mammograms. One study detected eight more cases per 1,000 women screened compared to mammograms alone. MRI's higher sensitivity allows it to find tumors that other methods might miss, particularly in women with dense breast tissue. This reduces the number of cancers that develop between regular screenings. Overall, MRI is a promising tool for screening high-risk women, potentially leading to better outcomes by catching cancer early. ^{4 5 6 7 8}

Who Is on the Research Team?

Olufunmilayo Olopade, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for women at high risk of breast cancer, including those with a history of breast or ovarian cancer who are now cancer-free for two years, have had chest radiation before age 35, or carry certain genetic mutations. African Ancestry women under 45 with family history of these cancers are also eligible. Participants must be willing to travel for imaging studies and follow-up procedures, give informed consent, and meet specific risk criteria based on genetic and non-genetic factors.

Inclusion Criteria

I am a woman under 45 of African Ancestry with a family history of breast or ovarian cancer.

I had breast or ovarian cancer but have been cancer-free for two years after completing all treatments.

I received radiation on my chest before I was 35.

Exclusion Criteria

I am currently on hormone therapy or participating in a chemoprevention trial.

I am currently receiving treatment for my cancer.

I have had kidney disease or problems with my kidney function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surveillance

Participants undergo intensive surveillance with MRI every 6 months and an annual screening mammogram

5 years

2 MRI visits per year, 1 mammogram visit per year

Follow-up

Participants are monitored for safety and effectiveness after surveillance

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Anxiety Self-management Techniques
• Clinical Hypnosis
• Magnetic Resonance Imaging (MRI)

Trial Overview The study is establishing a registry to monitor high-risk women using intensive surveillance methods like Magnetic Resonance Imaging (MRI) to detect early signs of breast cancer. It aims to improve early detection in those who have a significantly higher chance due to personal or familial factors.

How Is the Trial Designed?

Group I: Screening Arm Experimental Treatment 1 Intervention

Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram.

Magnetic Resonance Imaging (MRI) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as MRI for:

• Breast cancer screening for high-risk women
• Supplemental screening for women with dense breasts or personal history of breast cancer

Approved in European Union as MRI for:

• Breast cancer screening for high-risk women
• Supplemental screening for women with dense breasts or personal history of breast cancer

Approved in Canada as MRI for:

• Breast cancer screening for high-risk women
• Supplemental screening for women with dense breasts or personal history of breast cancer

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

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]

The introduction of MRI alongside mammography for breast cancer screening in high-risk women showed a high sensitivity of 93%, leading to the detection of fewer lymph node-positive cancers compared to mammography alone.

While there was no significant difference in 10-year survival rates between the MRI + mammography and mammography-only groups, the MRI-screened group had a significantly higher survival rate (95.3%) compared to those with no intensive screening (73.7%), indicating a potential benefit of MRI in high-risk populations, especially BRCA2 carriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI breast screening in high-risk women: cancer detection and survival analysis. Evans, DG., Kesavan, N., Lim, Y., et al.[2022]

In a study involving 1561 women at intermediate and high breast cancer risk, standard imaging with MRI did not result in greater psychological distress compared to standard imaging alone, indicating that both modalities are similarly safe in terms of psychological impact.

Women with a personal history of breast cancer or those who perceived their risk as higher experienced greater psychological distress, highlighting the need for targeted support and information for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety and specific distress in women at intermediate and high risk of breast cancer before and after surveillance by magnetic resonance imaging and mammography versus standard mammography. Brédart, A., Kop, JL., Fall, M., et al.[2022]

In a study of 385 breast surveillance MRI examinations and clinical breast examinations (CBEs) for women at high risk of breast cancer, MRI showed a significantly higher cancer detection rate of 1.6% compared to 0% for CBE, highlighting the superior sensitivity of MRI in identifying breast cancer.

The recall rate for MRI was 11.2%, which exceeded the UK guideline target of 7%, suggesting that current guidelines may not accurately reflect achievable outcomes in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the utility of clinical breast examination and MRI in the surveillance of women with a high risk of breast cancer. Mihalco, SP., Keeling, SB., Murphy, SF., et al.[2020]

In a study of 1909 high-risk women screened for breast cancer, MRI demonstrated a significantly higher sensitivity (79.5%) for detecting invasive cancers compared to mammography (33.3%), making it a more effective screening tool.

The use of MRI led to the detection of a higher proportion of smaller tumors (43.2% were 10 mm or less) in the surveillance group compared to control groups, indicating that MRI may help identify cancers at an earlier stage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of MRI and mammography for breast-cancer screening in women with a familial or genetic predisposition. Kriege, M., Brekelmans, CT., Boetes, C., 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]

Current evidence suggests that breast MRI improves outcomes primarily for BRCA mutation carriers and women with a strong family history of breast cancer, but its routine use in newly diagnosed patients remains debated.

MRI may offer potential benefits in evaluating responses to neoadjuvant therapy, indicating its role in predicting treatment effectiveness, although further research is needed to clarify its impact on surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 2013 Society of Surgical Oncology Susan G. Komen for the Cure Symposium: MRI in breast cancer: where are we now? McLaughlin, S., Mittendorf, EA., Bleicher, RJ., et al.[2020]

In a study of 141 women treated for breast cancer, only 0.9% of surveillance breast MRIs detected new cancers, indicating a low yield for this imaging method in identifying recurrences or new cancers post-treatment.

Factors such as patient age, Gail score, and tumor characteristics did not predict the use of breast MRI surveillance, highlighting the need for standardized guidelines to avoid unnecessary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast MRI surveillance in women with prior curative-intent therapy for breast cancer. Elmore, L., Margenthaler, JA.[2010]

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, when used alongside mammography, demonstrated high sensitivity (88.1%) for detecting breast cancer in a study of 821 patients, correctly identifying 356 out of 404 cancer cases.

While MRI showed a higher positive predictive value (72.4%) compared to mammography (52.8%), it still had moderate specificity (67.7%), indicating that further tissue sampling is necessary even after MRI results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of the breast prior to biopsy. Bluemke, DA., Gatsonis, CA., Chen, MH., 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]

In a study of 4454 women with non-metastatic breast cancer, preoperative MRI did not show a significant benefit in reducing breast cancer-specific or all-cause mortality, with 20.6% of participants undergoing MRI.

The results suggest that while preoperative MRI is commonly used, it does not improve surgical outcomes or survival rates, indicating a need to focus on patient-reported outcomes and decision-making confidence regarding treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative breast MRI and mortality in older women with breast cancer. Onega, T., Zhu, W., Weiss, JE., et al.[2019]

Breast MRI has a higher cancer detection rate (10.8 per 1000 examinations) compared to mammography (8.2 per 1000 examinations), indicating it may be more effective in identifying second breast cancer events in women with a history of breast cancer.

However, breast MRI also results in a significantly higher biopsy rate (10.1% vs. 4.0% for mammography) without showing improved sensitivity or lower interval cancer rates, suggesting that while it detects more cancers, it may lead to more unnecessary biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surveillance Breast MRI and Mammography: Comparison in Women with a Personal History of Breast Cancer. Wernli, KJ., Ichikawa, L., Kerlikowske, K., et al.[2023]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9997824/

Magnetic resonance imaging in screening women at high ... Among the 1000 screened women, MRI alone increased the detection rate of breast cancer by 8 compared with mammography alone (RR 0.48, 95% CI ...

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 ... Breast MRI screening of women with extremely dense breasts has not been adopted although the evidence of a large reduction in interval cancer rate from a RCT.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa031759

Efficacy of MRI and Mammography for Breast-Cancer ... MRI appears to be more sensitive than mammography in detecting tumors in women with an inherited susceptibility to breast cancer.

5. 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.

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

Breast MRI A possible leak or tear of a breast implant. A high risk of breast cancer. This means lifetime risk of 20% or more. Risk tools that look at ...

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

Breast Magnetic Resonance Imaging (MRI) A breast MRI is a procedure in which large magnets and radiofrequencies are used to search for cancer. Learn in-depth information about this procedure.

8. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening

Recommendation: Breast Cancer: Screening The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of supplemental screening for breast ...