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Study: Should biannual MRIs replace annual mammograms in high-risk women?

The risk of breast cancer is exceptionally high in women who have a personal or family history of breast cancer or who carry a mutation in BRCA or certain other genes. More frequent screening is one strategy for early detection of breast cancer for these women. Study results presented at the 2017 San Antonio Breast Cancer Symposium suggest that MRI screening every 6 months may be more effective than the currently recommended annual breast MRI and annual mammogram in detecting early stage breast cancers-which are more treatable-in high-risk women. (2/1/18)

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Most relevant for: Women at increased risk for breast cancer due to an inherited mutation.

It may also be relevant for:

previvors
people with a genetic mutation linked to cancer risk
people with breast cancer

Relevance: High

Strength of Science: High

Research Timeline: Post Approval

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Breast Cancer News

Biannual MRI better than annual mammogram at detecting breast cancer in high-risk women, study finds
This article rates 4.0 out of 5 stars

Science Daily

For women with genetic risk, semi-annual MRI beats mammograms
This article rates 3.5 out of 5 stars

At a glance	Questions for your doctor
Findings	In-depth
Clinical trials	Limitations
Guidelines	Resources

STUDY AT A GLANCE

This study is about:

Whether women at high risk for breast cancer benefit from biannual breast screening.

Why is this study important?

The National Comprehensive Cancer Network and the American Cancer Society recommend a screening breast MRI and a each year for high-risk women, typically starting at age 30. In studies of annual MRI, the cancer detection rates are quite variable. In most studies of annual MRI, only about half of the women in the study were diagnosed with small tumors (<1 cm) and some were diagnosed with lymph node positive tumors. Both the diagnosis of tumors larger than 1cm and lymph node positive tumors translates into more advanced disease.

Is the recommended screening regimen for high-risk women the best screening protocol? Questions remain, and many experts are concerned that the increased sensitivity of MRIs may result in false positives that require follow-up screening or biopsy, and increased psychosocial distress that may negatively impact a women’s quality of life. Three posters presented at the 2017 San Antonio Breast Cancer Symposium addressed these issues.

Study findings:

Between 2004 and 2016, researchers at the University of Chicago recruited high-risk women into a clinical trial to prospectively evaluate semiannual MRI and annual . Eligible participants had a lifetime breast cancer risk greater than 20% and/or an in , , , , or other cancer susceptibility gene. (More than half of the enrolled women had a mutation in a high-risk gene.) The participants’ median age was 44 (ranging from 21-73).

The 295 enrolled women were given a clinical breast exam and an MRI scan every 6 months, and a digital mammogram every 12 months:

At a median follow-up of 3.3 years (range 0-12 years), 3 cases of and 13 cases of invasive breast cancers were detected:
- 14 in women with inherited mutations (11 BRCA1, 2 BRCA2, 1 CDH1).
- Among all subjects, the annual incidence rate was 1.3%, but it was 3.5 % in BRCA1 carriers.
MRI correctly identified all 13 invasive cancers at a mean size of .61 cm, (about the size of a pea) (range .1-1.0 cm); none of the women had lymph node involvement.
Semiannual breast MRI demonstrated high sensitivity without substantially increasing recall rates or biopsy rates to an unacceptable value.
- Patients with BRCA1 mutations had the lowest biopsy rates needed to detect one cancer as well as higher cancer detection rates than non-BRCA1 carriers.
Semiannual breast MRI did not increase anxiety, depression or contribute to a decline in mental health over time.

What does this mean for me?

If you are at high risk for breast cancer, this study suggests that having an MRI every 6 months may be more effective for detecting early-stage breast cancer than an annual MRI and mammogram. In this study, the MRI cancer detection rates are comparable to previous studies looking at MRI. Where this study is unique and meaningful is that it was able to detect earlier stage cancers that are likely more curable and consequently may lead to improved survival in high-risk women.

This study also suggests that semiannual MRIs do not substantially increase recall or biopsy rates; nor do they increase anxiety or depression. This study also suggests that biannual MRI may be an especially effective screening tool for BRCA1 mutation carriers. The study’s lead author, Olufunmilayo Olopade, MD, professor of medicine and human genetics and director of the University of Chicago's Center for Clinical Cancer Genetics was quoted in the media articles, saying " remain important for most women. But for women at high risk who are getting an MRI every six months, annual mammograms could probably be eliminated."

Screening breast MRIs for women are not without controversy. Guidelines recommend that they be given with a contrast agent—an intravenous substance that enhances MRI imaging and makes it easier to identify abnormalities. Most contrast agents used for MRI include gadolinium, a metal-based chemical. Experts have expressed concern about the safety of gadolinium, primarily because it remains in patients’ brains and bodies for months to years. The required that labels for gadolinium-based contrast agents be updated to include a warning and safety measures that should be followed before the agents are given to patients.

Posted 2/1/18

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References

Whitaker K, Guindalini R, Abe H, Huo D, Hong S, Churepek J, Verp M, Obeid E, Zheng Y, Amico A, Yoshimatsu T, Olopade O. “Breast cancer surveillance in high-risk women with dynamic contrast-enhanced magnetic resonance imaging every 6 months: Results from a single institution study.” Poster presented at San Antonio Breast Cancer Symposium, December 8, 2017.

Whitaker K, Abe H, Sheth D, Huo D, Yoshimatsu TF, Zheng Y, Karczmar G, Guindalini R, Olopade O. “Recall rates during breast cancer surveillance in high-risk women with dynamic contrast-enhanced magnetic resonance imaging every 6 months: Results from a singl institution study”. Poster presented at San Antonio Breast Cancer Symposium, December 8, 2017.

Amico A, Fang R, Raoul A, Wroblewski K, Nielsen S, Weipert C, Abe H, Sheth D, Romero I, Kulkarni K, Schacht D, Patrick-Miller L, Verp M, Bradbury AR, Hlubocky F, Olopade O. “Psychosocial impact of a multi-modality surveillance program for women at high-risk for breast cancer”. Poster presented at San Antonio Breast Cancer Symposium, December 8, 2017.

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

This article is also relevant for:

previvors
people with a genetic mutation linked to cancer risk
people with breast cancer

IN-DEPTH REVIEW OF RESEARCH

Study background:

Women with a personal or family history of breast cancer or a mutation in BRCA1, BRCA2 or certain other genes have a higher-than-normal risk of breast cancer. An intensified screening regimen—annual MRI and annual mammogram–is currently recommended as an early detection strategy for these high-risk women. However, experts still have questions regarding the type and frequency of screening that is best for high-risk women.

Researchers of this study wanted to know:

Whether women at high risk for breast cancer benefit from biannual breast MRI screening.

Population(s) in the study:

Women enrolled in the study had mutations in one of 11 known breast cancer-related genes, a diagnosis of breast cancer or carcinoma in situ before age 35, or a mother or sister who was diagnosed with breast cancer before age 50 (before age 40 for African Americans). The mean age at participation was 43.3 years.

Participants had semiannual breast MRI and annual mammography. During the study, researchers performed 2,111 MRIs (averaging about 7 per participant) and 1,223 mammograms (4 per participant). Biopsy was recommended when mammography results were categorized as suspicious or highly suspicious. Further imaging was recommended and biopsy was performed if clinically indicated when MRI results were incomplete and mammography was suspicious or highly suspicious. Patients also completed psychosocial assessments when they began the study and at subsequent 6-month visits; psychosocial assessments were completed for 232 of 295 (79%) participants.

All study subjects were tested for inherited mutations in 12 genes that are associated with increased breast cancer risk via panel testing. Women with high-risk mutations who completed 5 years of the study protocol were offered continued screening.

Study findings:

At a median follow-up of 3.3 years (range 0-12 years), 3 cases of DCIS and 13 cases of early-stage, invasive breast cancers were detected:
- 14 cases were in subjects with inherited mutations (11 BRCA1, 2 BRCA2, 1 CDH1).
- Among all subjects, the annual incidence rate was 1.3%, but it was 3.5 % in BRCA1 carriers.
- None of the 16 diagnosed patients had lymph node involvement.
- 13 invasive cancers were detected (mean size of 0.61 cm, range 0.1-1.0 cm).
- 7 breast cancers were identified by MRI at the 6-month screening interval.
Semiannual breast MRI did not cause elevated states of anxiety or depression or a decline in mental health over time.
Participants had no significant demographic differences (age, race, income, mutation, and cancer type or cancer history) or psychosocial factors (baseline anxiety, depression or quality-of-life measures.
Semiannual breast MRI demonstrated high sensitivity (correctly identified breast cancers) and specificity (correctly identified the absence of breast cancer) without increasing rates of recall (being called back for an additional screening) and biopsy beyond an acceptable threshold.
- MRI sensitivity and specificity was 93.7% and 96.6%, respectively
- mammogram sensitivity and specificity was 50% and 97.7%, respectively
- The recall rate was 4.2% for MRI and 2.6% for mammography.
- 89 women had 106 recalls: 74 from MRI imaging alone, 18 from mammography and 14 from combined MRI and mammography.
- 56 biopsies were performed, resulting in the diagnosis of 3 DCIS and 13 invasive breast cancers.
- On average, MRI caused more recalls and follow-up per diagnosis than mammography: statistically, almost 6 women were recalled with 3.3 biopsies per diagnosis, compared to 4 women recalled with 2.1 biopsies per diagnosis, respectively.

Limitations:

This single-institution research shows bi-annual breast MRIs, radiology reader expertise, careful clinical decision making, and improved MRI technology at the University of Chicago can detect early-stage breast cancer more effectively than an annual MRI and mammogram. Other institutions with different cohorts of women may observe varying rates of success with biannual MRI screening. In addition, this study involved a relatively small sample size: only 295 women. Thus, this innovative screening approach needs to be further evaluated to refine and personalize breast cancer risk assessment and prevention.

Conclusions:

In this study, biannual breast MRI accomplished the ultimate goal of breast cancer screening—detecting node-negative, invasive tumors smaller than 1 cm. Semiannual MRI performed especially well in BRCA1 mutation carriers who are at increased risk for the most aggressive subtype of breast cancer. Bi-annual MRI did not cause a significantly elevated state of depression or anxiety or a significant decline in mental health over time, regardless of cancer history or genetic mutation status. Finally, this single institution MRI protocol achieved recall rates lower than those considered acceptable for annual MRI or mammography.

Study co-author, Mary-Claire King, PhD said, "The central goal of our study was to understand the needs of the highest risk women. My concern is that mammography and MRI be used in ways that make sense given a woman's personal genetics. Women with mutations in BRCA1 or BRCA2 have very different needs for surveillance for breast disease than do women with no mutations in these genes. This is particularly true for healthy young women with mutations. It's truly critical to offer intensive surveillance to still-healthy women with BRCA1 or BRCA2 mutations."

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Posted 2/1/18

Expert Guidelines

The National Comprehensive Cancer Network (NCCN) provides breast cancer risk-management guidelines for people with BRCA1 and BRCA2 mutations. We recommend that you speak with a genetics expert who can review your personal and family history of cancer and help you to determine the best risk management plan. Note that our use of "men" and "women" refers to the sex you were assigned at birth.

Recommended screening for women with mutations:

Beginning at age 18, be aware of how your breasts normally look and feel. Tell your doctor about any breast changes.
Beginning at age 25, have a doctor examine your breasts every 6-12 months.
Beginning at age 25, have an annual breast MRI with contrast (or mammogram if MRI is unavailable).
Beginning at age 30 and continuing until age 75, have an annual mammogram and an annual breast MRI with contrast.
After age 75, speak with your doctor about the benefits and risks of screening.

Risk reduction for women:

Speak with your doctor about the advantages and disadvantages of risk-reducing mastectomy.
- Research shows that risk-reducing mastectomy can lower the chance of developing breast cancer in high-risk women by about 90 percent. Mastectomy has not been shown to help high-risk women live longer.
- Because some breast tissue remains after mastectomy, some breast cancer risk also remains.
Speak with your doctor about the benefits and risks of tamoxifen or other estrogen-blocking drugs to reduce your breast cancer risk. The benefits and risks may be different for women with BRCA1 or BRCA2 mutations. Research on the benefit of these drugs to reduce breast cancer risk in women with BRCA1 mutations has been mixed.

Risk management for men:

Beginning at age 35, learn how to do breast self-exams to check for breast changes.
Beginning at age 35, have a doctor examine your chest every 12 months.
Beginning at age 50, consider an annual mammogram (especially for men with BRCA2 mutations).

Updated: 06/21/2024

Expert Guidelines

The National Comprehensive Cancer Network (NCCN) provides guidelines for management of breast cancer risk in people with inherited mutations linked to breast cancer. We recommend that you speak with a genetics expert who can look at your personal and family history of cancer and help you determine the best risk management plan.

or CHEK2

Beginning at age 40 (or earlier based on your family history of breast cancer)
- recommend yearly mammogram
Beginning at age 30-35
- consider yearly MRI with and without contrast

, or

Beginning at age 40 (or earlier based on family history):
- recommend yearly mammogram
- consider yearly breast MRI with and without contrast

No specific breast cancer screening guidelines. Risk management should be based on your family history of cancer.

CDH1

Beginning at age 30 (or earlier based on family history):
- recommend yearly mammogram
- consider yearly breast MRI with contrast
- discuss risk-reducing mastectomy

PALB2

Beginning at age 30 (or earlier based on family history):
- recommend yearly mammogram
- recommend yearly breast MRI with and without contrast
- discuss risk-reducing mastectomy with your doctor

PTEN

Beginning at age 18, learn to be aware of changes in breasts.
Beginning at age 25:
- clinical breast exam every 6-12 months beginning at age 25 or 10 years earlier than the youngest age of onset in the family
Beginning at age 30:
- yearly mammography and breast MRI with contrast beginning at age 30 or earlier based on the youngest breast cancer in the family
- discuss risk-reducing mastectomy with your doctor
After age 75
- discuss benefits and limitations of continued screening with your doctor

STK11

Beginning at age 30:
- clinical breast examination by a health care provider every 6 months starting at age 30
- recommend yearly mammogram
- recommend yearly MRI with and without contrast
- discuss risk-reducing mastectomy with your doctor

TP53

Beginning at age 18, learn to be aware of changes in your breasts.
Beginning at age 20:
- clinical breast examination by a healthcare provider every 6 months
- recommend yearly breast MRI with and without contrast beginning at age 20 or at the age of earliest breast cancer diagnosis if there is a history of breast cancer before age 20 in family
Beginning at age 30
- recommend yearly mammogram
Consider risk reducing mastectomy.
After age 75
- discuss benefits and limitations of continued screening with your doctor

Updated: 12/17/2023

Expert Guidelines

The National Comprehensive Cancer Network (NCCN) establishes guidelines for women with increased risk (a lifetime risk for breast cancer of 20 percent or more). The guidelines recommend the following screening:

Have clinical exams every 6–12 months, starting when you are identified as being at increased risk, but not before age 21.
Consider consulting with a genetic counselor or similarly trained health care provider, if you haven’t already done so.
Consider consulting with a breast surgeon.
Start annual mammography screening at age 40 or 10 years earlier than the age of the youngest family member who has been diagnosed with breast cancer, but not before age 30. Consider getting a .
Begin annual breast MRI at age 40 or 10 years earlier than the age of the youngest family member who has been diagnosed with breast cancer, but not before age 25.
Consider recommended risk reduction strategies, such as preventive hormonal medications.
Develop breast awareness and report any changes to your health care providers.

NCCN has separate guidelines for breast screening in women with an inherited mutation. See our gene-by-gene listing to find specific risk-management guidelines for people with an inherited mutation linked to cancer.

Updated: 03/28/2022

Questions To Ask Your Doctor

How often and with what method should I be screened for breast cancer?
Will my MRI include contrast with a gadolinium-based agent? If so, what health risks are associated with this contrast agent?
Are there any other health risks associated with getting an MRI every 6 months instead of annually?
Do I still need an annual mammogram if I have an MRI every 6 months?
Will my insurance cover more frequent MRI screenings?

Open Clinical Trials

The following are breast cancer screening or prevention studies enrolling people at high risk for breast cancer:

The Risk Factor Analysis of Hereditary Breast and Ovarian Cancer In Women with BRCA1, BRCA2 or PALB2 Mutations. This study seeks to improve researchers’ understanding of how hormonal, reproductive and lifestyle factors may be associated with cancer in high-risk people.
NCT02620852: Women Informed to Screen Depending on Measures of Risk (WISDOM) study. The goal of this study is to determine whether breast cancer screening can be improved by personalizing each woman’s mammogram schedule compared to the current one-size-fits-all annual approach.

Additional risk-management clinical trials for people at high risk for breast cancer may be found here.

Updated: 05/28/2025

Who covered this study?

Breast Cancer News

Biannual MRI better than annual mammogram at detecting breast cancer in high-risk women, study finds This article rates 4.0 out of 5 stars

Science Daily

For women with genetic risk, semi-annual MRI beats mammograms This article rates 3.5 out of 5 stars

News18.com

Bi-annual MRIs helps high risk breast cancer patients This article rates 1.0 out of 5 stars

How we rated the media

Study: Should biannual MRIs replace annual mammograms in high-risk women?

Relevance: High

Strength of Science: High

Research Timeline: Post Approval

Who covered this study?

Contents

STUDY AT A GLANCE

This study is about:

Why is this study important?

Study findings:

What does this mean for me?

References

Disclosure

This article is relevant for:

This article is also relevant for:

Be part of XRAY:

IN-DEPTH REVIEW OF RESEARCH

Study background:

Researchers of this study wanted to know:

Population(s) in the study:

Study findings:

Limitations:

Conclusions:

Expert Guidelines

Expert Guidelines

Recommended screening for women with BRCA mutations:

Risk reduction for women:

Risk management for men:

Expert Guidelines

ATM or CHEK2

BARD1, RAD51C or RAD51D

BRIP1

CDH1

PALB2

PTEN

STK11

TP53

Expert Guidelines

Questions To Ask Your Doctor

Open Clinical Trials

Related Resources

Who covered this study?

Knowledge Can Save Lives

Recommended screening for women with mutations:

or CHEK2

, or