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

Trial Summary

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 data supports the effectiveness of the treatment Anxiety Self-management Techniques, Anxiety Management Strategies, Stress Reduction Techniques, Clinical Hypnosis, Hypnotic Medicine, Hypnotherapy, Clinical Hypnotherapy, Magnetic Resonance Imaging (MRI), MRI, Magnetic Resonance Imaging, Breast MRI for high-risk breast cancer?

The research indicates that using MRI for breast cancer screening in high-risk women, particularly those with BRCA2 mutations, improves cancer detection and survival rates compared to no intensive screening. MRI combined with mammography has a high sensitivity for detecting breast cancer, which can lead to better outcomes for these women. ^{1 2 3 4 5}

Is breast MRI safe for humans?

Breast MRI is generally considered safe for humans, but there are concerns about false-positive results, which can lead to unnecessary stress and additional testing. ^{6 7 8 9 10}

How does MRI surveillance differ from other treatments for high-risk breast cancer?

MRI surveillance is unique because it uses magnetic resonance imaging to detect breast cancer in high-risk women, especially those with dense breast tissue, where traditional mammography may be less effective. It offers higher cancer detection rates and can improve survival outcomes compared to no intensive screening, particularly in women with genetic predispositions like BRCA2 carriers. ^{1 3 11 12 13}

What is the purpose of this trial?

This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.

Research Team

Olufunmilayo Olopade, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

MRI breast screening in high-risk women: cancer detection and survival analysis. [2022]

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

Breast MRI surveillance in women with prior curative-intent therapy for breast cancer. [2010]

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

Efficacy of MRI and mammography for breast-cancer screening in women with a familial or genetic predisposition. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Preoperative breast MRI and mortality in older women with breast cancer. [2019]

5. United States 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? [2020]

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

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

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

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

8. 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]

9. 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]

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

Magnetic resonance imaging of the breast prior to biopsy. [2023]

11. England 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. [2022]

12. England 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. [2020]

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

Surveillance Breast MRI and Mammography: Comparison in Women with a Personal History of Breast Cancer. [2023]