Revised 2023
ACR Appropriateness Criteria
®
1 Female Breast Cancer Screening
American College of Radiology
ACR Appropriateness Criteria
®
Female Breast Cancer Screening
Variant 1: Adult female. Breast cancer screening. Average risk.
Procedure Appropriateness Category Relative Radiation Level
Digital breast tomosynthesis screening Usually Appropriate
☢☢
Mammography screening Usually Appropriate
☢☢
US breast May Be Appropriate
O
MRI breast without and with IV contrast May Be Appropriate
O
MRI breast without and with IV contrast
abbreviated
May Be Appropriate
O
Mammography with IV contrast Usually Not Appropriate
☢☢
MRI breast without IV contrast Usually Not Appropriate
O
MRI breast without IV contrast abbreviated Usually Not Appropriate
O
Sestamibi MBI Usually Not Appropriate
☢☢☢
Variant 2: Adult female. Breast cancer screening. Intermediate risk.
Procedure Appropriateness Category Relative Radiation Level
Digital breast tomosynthesis screening Usually Appropriate
☢☢
Mammography screening Usually Appropriate
☢☢
US breast May Be Appropriate
O
Mammography with IV contrast May Be Appropriate
☢☢
MRI breast without and with IV contrast May Be Appropriate
O
MRI breast without and with IV contrast
abbreviated
May Be Appropriate
O
MRI breast without IV contrast Usually Not Appropriate
O
MRI breast without IV contrast abbreviated Usually Not Appropriate
O
Sestamibi MBI Usually Not Appropriate
☢☢☢
ACR Appropriateness Criteria
®
2 Female Breast Cancer Screening
Variant 3: Adult female. Breast cancer screening. High risk.
Procedure Appropriateness Category Relative Radiation Level
Digital breast tomosynthesis screening Usually Appropriate
☢☢
Mammography screening Usually Appropriate
☢☢
MRI breast without and with IV contrast Usually Appropriate
O
MRI breast without and with IV contrast
abbreviated
Usually Appropriate
O
US breast May Be Appropriate (Disagreement)
O
Mammography with IV contrast May Be Appropriate (Disagreement)
☢☢
MRI breast without IV contrast Usually Not Appropriate
O
MRI breast without IV contrast abbreviated Usually Not Appropriate
O
Sestamibi MBI Usually Not Appropriate
☢☢☢
ACR Appropriateness Criteria
®
3 Female Breast Cancer Screening
FEMALE BREAST CANCER SCREENING
Expert Panel on Breast Imaging: Bethany L. Niell, MD, PhD
a
; Maxine S. Jochelson, MD
b
; Tali Amir, MD
c
;
Ann Brown, MD
d
; Megan Adamson, MD
e
; Paul Baron, MD
f
; Debbie L. Bennett, MD
g
; Alison Chetlen, DO
h
;
Sandra Dayaratna, MD
i
; Phoebe E. Freer, MD
j
; Lillian K. Ivansco, MD, MPH
k
; Katherine A. Klein, MD
l
;
Sharp F. Malak, MD, MPH
m
; Tejas S. Mehta, MD, MPH
n
; Linda Moy, MD
o
; Colleen H. Neal, MD
p
;
Mary S. Newell, MD
q
; Ilana B. Richman, MD, MHS
r
; Mara Schonberg, MD, MPH
s
; William Small Jr., MD
t
;
Gary A. Ulaner, MD, PhD
u
; Priscilla J. Slanetz, MD, MPH.
v
Summary of Literature Review
Introduction/Background
Breast cancer is the most common nonskin cancer diagnosis in women and is second only to lung cancer with
respect to cancer deaths. Early detection of breast cancer from regular screening substantially reduces breast cancer
mortality [1]. Because regular screening identifies tumors when they are smaller and with fewer nodal metastases,
patients with screen-detected breast cancers are less likely to require mastectomy or chemotherapy, thereby also
decreasing morbidity [2].
Breast cancer risk is frequently divided into 3 major categories: average, intermediate, and high risk. Numerous
factors contribute to breast cancer risk, so no single method or definition is used to classify each woman into a
specific risk category [3,4]. The use of validated statistical models based largely upon family history, which also
incorporate additional risk factors, represents one mechanism to estimate risk. Currently, risk categories are most
frequently defined by estimated lifetime risk; however, different time horizons, such as 5 or 10 year risk, may also
be valuable for guideline development and informed decision-making [3]. Women at average risk are typically
defined as those with <15% estimated lifetime risk for developing breast cancer, whereas intermediate-risk women
are generally defined as those with a 15% to 20% estimated lifetime risk. The high-risk category typically includes
women who have a >20 to 25% estimated lifetime risk: women who carry a deleterious genetic mutation that
increases breast cancer risk, as well as untested first-degree relatives of patients with these mutations and women
who have received radiation therapy to the thorax or upper abdomen at an early age (<30 years). Some women with
a personal history of high-risk breast lesions, a personal history of breast cancer, dense breast tissue, or a family
history of breast cancer may fit into the intermediate- or high-risk categories, depending upon their specific risk
factors or combination of factors [3]. Elevated risk is sometimes used to refer to women in both the intermediate-
and high-risk categories [3].
Breast cancer screening guidelines vary across medical professional organizations, although published guidelines
agree that regular breast cancer screening decreases morbidity and breast cancer mortality [5-7]. Medical
professional organizations may also define breast cancer risk categories using different methodologies. Although
screening guidelines for high-risk patients have typically been similar, discrepant recommendations for average-
and intermediate-risk women have sparked controversy and confusion. In part due to differences in screening
guidelines, use of breast cancer screening modalities remains suboptimal in women of all risk categories. The ACR
encourages patients to undergo breast cancer risk assessment by 25 years of age, so elevated-risk patients have the
opportunity to benefit from earlier and more aggressive breast cancer screening regimens, when appropriate [3].
The ACR recommends that both the benefits and risks of breast cancer screening and supplemental screening be
considered to assist patients in making informed decisions regarding their health care [8].
a
Panel Chair, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
b
Memorial Sloan Kettering Cancer Center, New York, New York.
c
Memorial Sloan Kettering Cancer Center, New York, New York.
d
Panel Vice-Chair, University of Cincinnati, Cincinnati, Ohio.
e
Clinica Family Health,
Lafayette, Colorado; American Academy of Family Physicians.
f
Lenox Hill Hospital, Northwell Health, New York, New York; American College of Surgeons.
g
Washington University School of Medicine, Saint Louis, Missouri.
h
Penn State Health Hershey Medical Center, Hershey, Pennsylvania.
i
Thomas Jefferson
University Hospital, Philadelphia, Pennsylvania; American College of Obstetricians and Gynecologists.
j
University of Utah, Salt Lake City, Utah.
k
Kaiser
Permanente, Atlanta, Georgia.
l
University of Michigan, Ann Arbor, Michigan.
m
St. Bernards Healthcare, Jonesboro, Arkansas.
n
UMass Memorial Medical
Center/UMass Chan Medical School, Worcester, Massachusetts.
o
NYU Clinical Cancer Center, New York, New York.
p
ProMedica Breast Care, Toledo, Ohio.
q
Emory University Hospital, Atlanta, Georgia; RADS Committee.
r
Yale School of Medicine, New Haven, Connecticut; Society of General Internal Medicine.
s
Harvard Medical School, Boston, Massachusetts; American Geriatrics Society.
t
Loyola University Chicago, Stritch School of Medicine, Department of
Radiation Oncology, Cardinal Bernardin Cancer Center, Maywood, Illinois; Commission on Radiation Oncology.
u
Hoag Family Cancer Institute, Newport
Beach, California and University of Southern California, Los Angeles, California; Commission on Nuclear Medicine and Molecular Imaging.
v
Specialty Chair,
Boston University School of Medicine, Boston, Massachusetts.
The American College of Radiology seeks and encourages collaboration with other organizations on the development of the ACR Appropriateness
Criteria through representation of such organizations on expert panels. Participation on the expert panel does not necessarily imply endorsement of the final
document by individual contributors or their respective organization.
Reprint requests to: publication[email protected]
ACR Appropriateness Criteria
®
4 Female Breast Cancer Screening
Although all patients are at risk for developing breast cancer, this document addresses breast cancer screening in
cisgender females (birth assigned female with a female gender identity). For breast cancer screening in transgender
and gender diverse patients, please reference the ACR Appropriateness Criteria
®
topic on Transgender Breast
Cancer Screening [9]. Additional ACR Appropriateness Criteria
®
topics on Supplemental Breast Cancer
Screening Based on Breast Density[10], Imaging after Mastectomy and Breast Reconstruction[11], Imaging
after Breast Surgery[12], and Breast Imaging of Pregnant and Lactating Women[13] can be referenced in the
appropriate clinical context.
Discussion of Procedures by Variant
Variant 1: Adult female. Breast cancer screening. Average risk.
Digital Breast Tomosynthesis Screening
Digital breast tomosynthesis (DBT) displays reconstructed stacked images of the breast in combination with digital
mammographic views, which may be synthetic mammograms reconstructed from the acquired tomosynthesis data
set or full-field digital mammograms (FFDM). Compared to FFDM or synthetic mammograms alone, most studies
demonstrate that DBT increases cancer detection rate (CDR) and decreases recall rate [14-22]; although some
studies have not reached statistical significance [23] or have found less compelling results in subsets of women,
such as those with extremely dense breasts [24,25]. Dense breast tissue decreases the sensitivity of mammography
[26] and is an independent risk factor for developing breast cancer [27]. Compared to average breast density (near
the threshold between heterogeneously dense and scattered areas of fibroglandular density), the relative risks for
developing breast cancer are 1.2 for heterogeneously dense and 2.1 for extremely dense breasts [28]. Some health
care providers may therefore consider women with extremely dense breasts to no longer be average risk. Irrespective
of risk category, meta-analyses have demonstrated an incremental increase in CDR of 1.6 to 3.2 per 1,000 screening
DBT examinations and a 2.2% pooled decrease in recall rate compared to digital mammography [18,29,30].
The degree of breast cancer mortality reduction from screening mammography varies with different screening
regimens. Mortality reduction is greater when screening begins at 40 years of age rather than 45 or 50 years of age
and when screening is done more frequently (annually rather than biennially) [8,31]. Beginning screening at an
earlier age and more frequent screening result in a greater number of imaging studies performed, so these screening
regimens may also increase the number of false-positive examinations and biopsies [8,32]. To maximize the
benefits, the ACR recommends screening DBT in average-risk women each year beginning at 40 years of age.
Although randomized controlled trials of screening mammography did not enroll women >74 years of age,
observational studies demonstrate that some women 75 years of age may continue to benefit from screening
mammography [8,32]. There is no upper age limit agreed upon for screening mammography [5,6,8,32]. Because
mortality reduction from screening mammography requires years before being fully attained, screening
recommendations should be based upon life expectancy and competing comorbidities, rather than age alone [8,32-
34]. Women should continue screening mammography as long as they remain in overall good health and are willing
to undergo the examination and subsequent testing or biopsy, if an abnormality is identified [5,8].
Because screening mammography decreases breast cancer mortality, screening mammography or screening DBT
is still performed in women undergoing supplemental screening studies [3,8,35].
Mammography Screening
To date, mammography is the only screening modality shown to decrease breast cancer mortality. Multiple
randomized controlled trials demonstrate that invitation to screening mammography results in at least a 22%
reduction in breast cancer mortality [35]. For example, after 29 years of follow-up, the Swedish Two-County trial
demonstrated a 27% to 31% reduction in breast cancer mortality in 133,065 women 40 to 74 years of age invited to
screening despite use of single view mammography and the 24 to 33 month interval between subsequent screenings
[1]. Randomized controlled trials of screening mammography in which advanced stage breast cancers decreased by
20% or more demonstrate even greater reductions in breast cancer mortality [8]. Observational studies, including
those from population-based service screening programs, also demonstrate larger reductions in breast cancer
mortality (≥40%) in women who were actually screened [8,35].
In addition to mortality reduction, screening mammography decreases treatment morbidity, because screen-detected
tumors are typically lower stage (eg, smaller and more likely to be node-negative), compared to breast cancers
detected by palpation [2,8]. Despite these benefits, screening mammograms also have risks. The most common
perceived risks include false-positive recalls and biopsies, overdiagnosis, and patient anxiety [5,7,32].
Approximately 10% of screening mammograms result in a recall for additional imaging, although <2% result in a
ACR Appropriateness Criteria
®
5 Female Breast Cancer Screening
recommendation for percutaneous biopsy following additional imaging [8]. Overdiagnosis refers to breast cancers
that are detected by screening that would not have otherwise become apparent during the patient’s lifetime. The
reported frequency of overdiagnosis varies widely in the published literature due to important underlying
differences in study methodology. Overdiagnosis estimates that do not account for breast cancer risk, trends in
breast cancer incidence, or lead time bias range from 0% to 54%, whereas adjusted estimates range from 1% to 10%
[36,37]. Overdiagnosis estimates increase with age at screening [36,37]. Although the risks of screening may impact
uptake and adherence to screening mammography, prior research has shown that women value early detection of
breast cancer over false-positives and screening-related anxiety [8].
Despite the established mortality benefit, published guidelines differ in their recommendations for screening
mammography due to variations in the perceptions of the relative risks and benefits [5,38]. The degree of breast
cancer mortality reduction from screening mammography varies with different screening regimens. Mortality
reduction is greater when screening begins at 40 years of age rather than 45 or 50 years of age and when screening
is done more frequently (annually rather than biennially) [8,31]. Annual screening mammography for women 40 to
84 years of age decreases mortality by 40% (12 lives per 1,000 women screened), whereas biennial screening
mammography for women 50 to 74 years of age only decreases mortality by 23% (7 lives per 1,000 women
screened) [32]. Earlier initiation of screening and more frequent screening result in a greater number of imaging
studies performed, so these screening regimens also increase the number of false-positive examinations and biopsies
[8,32]. Although randomized controlled trials of screening mammography did not enroll women >74 years of age,
observational studies demonstrate that women ≥75 years of age may continue to benefit from screening
mammography [8,32]. There is no upper age limit agreed upon for screening mammography
[5,6,8,32]. Because
mortality reduction from screening mammography requires years before being fully attained, screening
recommendations should be based upon life expectancy and competing comorbidities, rather than age alone [8,32-
34]. Women should continue screening mammography as long as they remain in overall good health and are willing
to undergo the examination and subsequent testing or biopsy, if an abnormality is identified [5,8].
For women 40 to 49 years of age, randomized controlled trials and observational studies demonstrate that screening
mammography decreases breast cancer mortality by 15% to 50% [1,8,32,33,39]. Results from the Cancer
Intervention and Surveillance Modeling Network (CISNET) suggest that annual screening mammography in
women 40 to 49 years of age saves 42% more lives and life-years than biennial screening due to faster growing
tumors in younger women [31]. Women screened between 40 and 49 years of age are also less likely to require
mastectomy or chemotherapy than women diagnosed with palpable tumors [2].
Non-Hispanic Black, Hispanic Black, and Hispanic White women have higher breast cancer mortality than non-
Hispanic White women, and minority women often present at younger ages with more aggressive tumor subtypes
[3,8]. Therefore, decreasing access to screening mammography, especially in women 40 to 49 years of age, may
disproportionately impact minority women.
Annual screening mammography results in a greater reduction in mortality compared to biennial screening [8]. In
women 40 to 84 years of age, annual screening reduces mortality by 40%, compared to a 32% reduction for biennial
screening [32]. With regular screening, interval breast cancers do occur with a higher frequency in women
undergoing biennial or triennial screening compared to annual screening. The sensitivity of mammography is
decreased in some groups of women, including those with dense breasts [40]. Dense breast tissue decreases the
sensitivity of mammography [26] and is an independent risk factor for developing breast cancer [27]. Compared to
average breast density (near the threshold between heterogeneously dense and scattered areas of fibroglandular
density), the relative risks for developing breast cancer are 1.2 for heterogeneously dense and 2.1 for extremely
dense breasts [28]. Some health care providers may therefore consider women with extremely dense breasts to no
longer be average risk. Given the limitations of mammography and to minimize interval cancers, supplemental
screening modalities have been investigated in women at average risk.
Because screening mammography decreases breast cancer mortality, screening mammography or screening DBT
is still performed in women undergoing supplemental screening studies [3,8,35]. Rather than supplementing
screening mammography with additional imaging modalities, some have suggested limiting women offered
screening mammography based upon individual patient risk assessed by various risk models, breast density, or
genetic information such as single-nucleotide polymorphism. However, the randomized controlled trials
demonstrating mortality reduction and most large-scale observational studies enrolled women based upon
geographic location and age, not other individual patient risk factors. In one observational study in women <50
ACR Appropriateness Criteria
®
6 Female Breast Cancer Screening
years of age, restricting screening to women with a first-degree family history, extremely dense breast tissue, or
both, would cause 66% of potentially screen-detected cancers to be missed [41].
To maximize the benefits, the ACR recommends screening mammography in average-risk women each year
beginning at 40 years of age. Women should continue screening mammography as long as they remain in overall
good health and are willing to undergo the examination and subsequent testing or biopsy, if an abnormality is
identified [5,8].
Mammography With IV Contrast
Data are limited regarding the use of mammography with intravenous (IV) contrast for screening women at average
risk. Most published studies evaluated mammography with IV contrast in women with dense breasts and elevated
risk, so results specific to women at average risk, especially those without dense breasts, are not currently available.
For supplemental screening recommendations based upon breast density, please refer to the ACR Appropriateness
Criteria
®
topic onSupplemental Breast Cancer Screening Based on Breast Density[10].
MRI Breast Without and With IV Contrast
Although data are limited regarding the use of breast MRI without and with IV contrast for screening women at
average risk, one study has demonstrated that breast MRI demonstrates incremental cancer detection (15-16 cancers
per 1,000 breast MRI examinations) over screening mammography with or without screening ultrasound (US) in
average-risk women irrespective of breast density [42]. Breast MRI also decreases interval cancers [42,43]. In the
DENSE trial, breast MRI significantly reduced interval cancers within women with extremely dense breast tissue
and normal mammography, so the European Society of Breast Imaging now recommends screening breast MRI
every 2 to 4 years in women 50 to 70 years of age with extremely dense breasts [43,44]. Compared to average breast
density (near the threshold between heterogeneously dense and scattered areas of fibroglandular density), the
relative risks for developing breast cancer are 1.2 for heterogeneously dense and 2.1 for extremely dense breasts
[28]. Some health care providers may therefore consider women with extremely dense breasts to no longer be
average risk.
For supplemental screening recommendations based upon breast density, please refer to the ACR Appropriateness
Criteria
®
topic onSupplemental Breast Cancer Screening Based on Breast Density[10].
MRI Breast Without and With IV Contrast Abbreviated
Data are limited regarding the use of abbreviated breast MRI without and with IV contrast for screening women at
average risk. The ECOG-ACRIN abbreviated MRI trial demonstrated a significantly higher CDR for abbreviated
breast MRI without and with IV contrast (15 cancers per 1,000) compared with DBT (6 cancers per 1,000), although
the study recruited women with dense breasts [45]. In addition to dense breasts, women enrolled in the trial had
variable 5 and 10 year risk profiles based upon the Breast Cancer Surveillance Consortium risk calculator and 19%
reported 1 or more first degree relatives with breast cancer [45]. Compared to average breast density (near the
threshold between heterogeneously dense and scattered areas of fibroglandular density), the relative risks for
developing breast cancer are 1.2 for heterogeneously dense and 2.1 for extremely dense breasts [28]. Some health
care providers may therefore consider women with extremely dense breasts to no longer be average risk.
For supplemental screening recommendations based upon breast density, please refer to the ACR Appropriateness
Criteria
®
topic onSupplemental Breast Cancer Screening Based on Breast Density[10].
MRI Breast Without IV Contrast
There is no relevant literature to support the use of MRI without IV contrast for screening women at average risk.
MRI Breast Without IV Contrast Abbreviated
There is no relevant literature to support the use of abbreviated MRI without IV contrast for screening women at
average risk.
Sestamibi MBI
Data are limited regarding the use of sestamibi molecular breast imaging (MBI) for screening women at average
risk. Most studies have focused upon women with dense breasts and variable risk profiles. One of the larger studies
published to date of 1,696 women with recent negative or benign mammographic examinations showed that
sestamibi MBI yielded an incremental CDR of 7.7 cancers per 1,000 examinations; however, all 13 cancers were
detected in women with dense breasts [46]. Although 92% of the women within the study had <20% estimated
lifetime risk, the estimates ranged from 6.1% to 17.2% [46]. Additional retrospective and prospective studies have
demonstrated similar incremental CDR for sestamibi MBI of 6.5 to 9 per 1,000 over mammography [40,47].
ACR Appropriateness Criteria
®
7 Female Breast Cancer Screening
Sestamibi MBI demonstrates similar sensitivity, better specificity, and lower recall rate compared to supplemental
screening US in women with dense breasts [47,48].
US Breast
Most studies evaluating the utility of screening with breast US have focused on women with dense breast tissue
with or without other risk factors. Dense breast tissue decreases the sensitivity of mammography [26] and is an
independent risk factor for developing breast cancer [27]. Screening breast US in women with mammographically
dense breasts, including those with risk factors placing them at increased breast cancer risk, identifies
mammographically occult, small, node-negative invasive tumors with an increased CDR of 1.8 to 4.6 cancers per
1,000 women screened [40,49]. Although supplemental screening US in women with dense breasts results in an
increased CDR, US also increases recall rate, false-positive examinations, and false-positive biopsies [26,49-55].
For supplemental screening recommendations based upon breast density, please refer to the ACR Appropriateness
Criteria
®
topic onSupplemental Breast Cancer Screening Based on Breast Density[10].
Data regarding supplemental screening US in average-risk women with nondense breasts is less compelling. In a
study of 1,526 average-risk women without mammographic abnormalities, screening with US demonstrated an
overall incremental CDR of 3.3 per 1,000, with 5.1 per 1,000 examinations in dense breasts and 0 per 1,000 in
nondense breasts compared to digital mammography [56]. In another study of 1,003 average-risk women, US
yielded an overall incremental CDR of 3.2 per 1,000 examinations, with 0 per 1,000 in nondense breasts, compared
to DBT with or without digital mammography [53].
Variant 2: Adult female. Breast cancer screening. Intermediate risk.
Evidence-based screening recommendations for intermediate-risk women are complicated by different
methodologies for risk assessment using variable time spans (eg, lifetime, 5 year, 10 year), as well as the interplay
between breast density and additional risk factors [40]. Compared to average breast density (near the threshold
between heterogeneously dense and scattered areas of fibroglandular density), the relative risks for developing
breast cancer are 1.2 for heterogeneously dense and 2.1 for extremely dense breasts [28]. Some health care providers
may therefore consider women with extremely dense breasts to be at increased risk. Published data are primarily
from observational studies, which have been largely retrospective with variable risk assessment methods resulting
in heterogeneous patient groups. In a subset of the literature, intermediate-risk women have been grouped with
high-risk women or average-risk women without stratified analyses. The absence of high-quality prospective studies
of various supplemental imaging modalities specific to intermediate-risk patients creates challenges when
developing guidelines [40]. Depending upon family and personal history of breast cancer, prior biopsies yielding
high-risk lesions, and other risk factors, certain intermediate-risk women may benefit from screening starting at <40
years of age,
as well as more intensive screening regimens with supplemental imaging modalities [3].
Please reference the ACR Appropriateness Criteria
®
topics onTransgender Breast Cancer Screening” [9],
Supplemental Breast Cancer Screening Based on Breast Density[10], Imaging after Mastectomy and Breast
Reconstruction[11], Imaging after Breast Surgery[12], and Breast Imaging of Pregnant and Lactating Women
[13] in the appropriate clinical context.
Digital Breast Tomosynthesis Screening
DBT displays reconstructed stacked images of the breast in combination with digital mammographic views, which
may be synthetic mammograms reconstructed from the acquired tomosynthesis dataset or FFDM. Compared to
FFDM or synthetic mammograms alone, most studies demonstrate that DBT increases CDR and decreases recall
rate [14-22]; although, some studies have not reached statistical significance [23] or have found less compelling
results in subsets of women, such as those with extremely dense breasts [24,25]. Dense breast tissue decreases the
sensitivity of mammography [26] and is an independent risk factor for developing breast cancer [27]. Compared to
average breast density (near the threshold between heterogeneously dense and scattered areas of fibroglandular
density), the relative risks for developing breast cancer are 1.2 for heterogeneously dense and 2.1 for extremely
dense breasts [28]. Some health care providers may therefore consider women with extremely dense breasts to no
longer be average risk. Irrespective of risk category, meta-analyses have demonstrated an incremental increase in
CDR of 1.6 to 3.2 per 1,000 screening DBT examinations and a 2.2% pooled decrease in recall rate compared to
digital mammography [18,29,30].
The degree of breast cancer mortality reduction from screening mammography varies with different screening
regimens. Mortality reduction is greater when screening begins at 40 years of age rather than 45 or 50 years of age
ACR Appropriateness Criteria
®
8 Female Breast Cancer Screening
and when screening is done more frequently (annually rather than biennially) [8,31]. Beginning screening at an
earlier age and more frequent screening, result in a greater number of imaging studies performed, so these screening
regimens also increase the number of false-positive examinations and biopsies [8,32]. Although randomized
controlled trials of screening mammography did not enroll women >74 years of age, observational studies
demonstrate that some women ≥75 years of age may continue to benefit from screening mammography [8,32].
There is no upper age limit agreed upon for screening mammography [5,6,8,32]. Because mortality reduction from
screening mammography requires years before being fully attained, screening recommendations should be based
upon life expectancy and competing comorbidities, rather than age alone [8,32-34]. Women should continue
screening mammography as long as they remain in overall good health and are willing to undergo the examination
and subsequent testing or biopsy, if an abnormality is identified [5,8].
Within the limited studies of women at elevated risk due to personal and/or family history of breast cancer, DBT
decreased recall rate without a significant increase in CDR compared to FFDM; however, small sample sizes restrict
analyses [3,40].
Because screening mammography decreases breast cancer mortality, screening mammography or screening DBT
is still performed in women undergoing supplemental screening studies [3,8,35]. The ACR recommends annual
screening mammography beginning no later than 40 years of age for women at intermediate risk [3]. For those with
a family history of breast cancer, mammography should begin earlier if familial breast cancer occurred at a young
age, typically 10 years prior to the youngest age at presentation but generally not before age 30 [6]. For women who
have lobular neoplasia or atypical hyperplasia diagnosed prior to 40 years of age, annual screening mammography
should be performed from time of diagnosis but generally not prior to 30 years of age [38]. Early detection of second
breast cancers improves survival, so patients with a personal history of breast cancer should undergo annual
mammography or DBT for surveillance following breast conservation therapy [3].
Mammography Screening
To date, mammography is the only screening modality shown to decrease breast cancer mortality. Multiple
randomized controlled trials demonstrate that invitation to screening mammography results in at least a 22%
reduction in breast cancer mortality [35]. For example, after 29 years of follow-up, the Swedish Two-County trial
demonstrated a 27% to 31% reduction in breast cancer mortality in 133,065 women 40 to 74 years of age invited to
screening despite use of single view mammography and the 24 to 33 month interval between subsequent screenings
[1]. Randomized controlled trials of screening mammography in which advanced stage breast cancers decreased by
20% or more demonstrate even greater reductions in breast cancer mortality [8]. Observational studies, including
those from population-based service screening programs, also demonstrate larger reductions in breast cancer
mortality (≥40%) in women who were actually screened [8,35].
In addition to mortality reduction, screening mammography decreases treatment morbidity, because screen-detected
tumors are typically lower stage (eg, smaller and more likely to be node-negative) compared to breast cancers
detected by palpation [2,8]. Despite these benefits, screening mammograms also have risks. The most common
perceived risks include false-positive recalls and biopsies, overdiagnosis [5,7,32], and patient anxiety.
Approximately 10% of screening mammograms result in a recall for additional imaging, although <2% result in a
recommendation for percutaneous biopsy following additional imaging [8]. Overdiagnosis refers to breast cancers
that are detected by screening that would not have otherwise become apparent during the patient’s lifetime. The
reported frequency of overdiagnosis varies widely in the published literature, due to important underlying
differences in study methodology. Overdiagnosis estimates that do not account for breast cancer risk, trends in
breast cancer incidence, or lead time bias range from 0% to 54%, whereas adjusted estimates range from 1% to 10%
[36,37]. Overdiagnosis estimates increase with age at screening [36,37]. Although the risks of screening may impact
uptake and adherence to screening mammography, prior research has shown that women value early detection of
breast cancer over false-positives and screening-related
anxiety [8].
Despite the established mortality benefit, published guidelines differ in their recommendations for screening
mammography due to variations in the perceptions of the relative risks and benefits [5,38]. The degree of breast
cancer mortality reduction from screening mammography varies with different screening regimens. Mortality
reduction is greater when screening begins 40 years of age rather than 45 or 50 years of age and when screening is
done more frequently (annually rather than biennially) [8,31]. Annual screening mammography for women 40 to
84 years of age decreases mortality by 40% (12 lives per 1,000 women screened), whereas biennial screening
mammography for women 50 to 74 years of age only decreases mortality by 23% (7 lives per 1,000 women
screened) [32]. Earlier initiation of screening and more frequent screening result in a greater number of imaging
ACR Appropriateness Criteria
®
9 Female Breast Cancer Screening
studies performed, so these screening regimens also increase the number of false-positive examinations and biopsies
[8,32]. Although randomized controlled trials of screening mammography did not enroll women >74 years of age,
observational studies demonstrate that women ≥75 years of age may continue to benefit from screening
mammography [8,32]. There is no upper age limit agreed upon for screening mammography [5,6,8,32]. Because
mortality reduction from screening mammography requires years before being fully attained, screening
recommendations should be based upon life expectancy and competing comorbidities, rather than age alone [8,32-
34]. Women should continue screening mammography as long as they remain in overall good health and are willing
to undergo the examination and subsequent testing or biopsy, if an abnormality is identified [5,8].
For women 40 to 49 years of age, randomized controlled trials and observational studies demonstrate that screening
mammography decreases breast cancer mortality by 15% to 50% [1,8,32,33,39]. Results from the CISNET suggest
that annual screening mammography in women 40 to 49 years of age saves 42% more lives and life-years than
biennial screening due to faster growing tumors in younger women [31]. Women screened between 40 and 49 years
of age are also less likely to require mastectomy or chemotherapy than women diagnosed with palpable tumors [2].
Non-Hispanic black women, Hispanic black, and Hispanic white women have higher breast cancer mortality than
non-Hispanic white women, and minority women often present at younger ages with more aggressive tumor
subtypes [3,8]. Therefore, decreasing access to screening mammography, especially in women 40 to 49 years of
age, may disproportionately impact minority women.
Annual screening mammography results in a greater reduction in mortality compared to biennial screening [8]. In
women 40 to 84 years of age, annual screening reduces mortality by 40%, compared to a 32% reduction for biennial
screening [32]. With regular screening, interval breast cancers do occur with a higher frequency in women
undergoing biennial or triennial screening compared to annual screening. The sensitivity of mammography is
decreased in some groups of women, including those with dense breasts [40]. Dense breast tissue decreases the
sensitivity of mammography [26] and is an independent risk factor for developing breast cancer [27]. Compared to
average breast density (near the threshold between heterogeneously dense and scattered areas of fibroglandular
density), the relative risks for developing breast cancer are 1.2 for heterogeneously dense and 2.1 for extremely
dense breasts [28]. Some health care providers may therefore consider women with extremely dense breasts to no
longer be average risk. Given the limitations of mammography and to minimize interval cancers, supplemental
screening modalities have been investigated in women at intermediate risk.
Because screening mammography decreases breast cancer mortality, screening mammography or screening DBT
is still performed in women undergoing supplemental screening studies [3,8,35]. Rather than supplementing
screening mammography with additional imaging modalities, some have suggested limiting women offered
screening mammography based upon individual patient risk assessed by various risk models, breast density, or
genetic information such as single-nucleotide polymorphisms. However, the randomized controlled trials
demonstrating mortality reduction and most large-scale observational studies enrolled women based upon age and
geographic location, not individual patient risk factors. In one observational study in women <50 years of age,
restricting screening to women with a first-degree family history, extremely dense breast tissue, or both, would
cause 66% of potentially screen-detected cancers to be missed [41].
To maximize the benefits, the ACR recommends annual screening mammography beginning no later than 40 years
of age for women at intermediate risk [3]. Women should continue screening mammography as long as they remain
in overall good health and are willing to undergo the examination and subsequent testing or biopsy, if an abnormality
is identified [5,8]. For those with a family history of breast cancer, mammography should begin earlier if familial
breast cancer occurred at a young age, typically 10 years prior to the youngest age at presentation but generally not
before 30 years of age [6]. For women who have lobular neoplasia or atypical hyperplasia diagnosed prior to 40
years of age, annual screening mammography should be performed from time of diagnosis but generally not prior
to 30 years of age [38]. Early detection of second breast cancers improves survival, so patients with a personal
history of breast cancer should undergo annual mammography or DBT for surveillance following breast
conservation therapy [3].
Mammography With IV Contrast
Data are limited regarding the use of mammography with IV contrast for breast cancer screening in intermediate-
risk women. To date, published studies have predominantly included women with dense breasts and other risk
factors resulting in intermediate- or high-risk profiles. Compared to mammography alone, mammography with IV
contrast increases cancer detection (incremental CDR = 6.6-13 per 1,000) in women at elevated risk [57-60].
ACR Appropriateness Criteria
®
10 Female Breast Cancer Screening
MRI Breast Without and With IV Contrast
MRI has a higher CDR than mammography alone, DBT, or mammography/DBT combined with US [61-64]. The
incremental CDR of MRI in elevated-risk women ranges from 8 to 29 per 1,000 women, with lower CDR estimates
in intermediate-risk women compared to high-risk BRCA mutation carriers [61-63,65,66]. In one study, breast MRI
CDR was 15 per 1,000 in women with a prior biopsy demonstrating a high-risk lesion compared to 8 per 1,000 in
women reporting a family history [65]. In women with a personal history of breast cancer, a meta-analysis estimated
a CDR of 9 to 15 per 1,000 breast MRI [67]. Breast MRI detects small, node-negative invasive cancers at earlier
tumor stages compared to mammography, as well as ductal carcinoma in situ [68,69]. Screening MRI also reduces
interval cancers [69]. However, breast MRI has a higher recall rate than mammography (15.1% versus 6.4%) [70],
higher frequency of BI-RADS category 3 assessment than mammography (14.8% versus 11.8%), and greater
frequency of image-guided biopsies than mammography (11.8% versus 2.4%) [63].
MRI Breast Without and With IV Contrast Abbreviated
Data are limited regarding the use of abbreviated breast MRI without and with IV contrast in intermediate-risk
women. In one cohort of women deemed at “mildly to moderately increased risk” abbreviated breast MRI
demonstrated an incremental cancer detection yield of 18 cancers per 1,000 and a high negative predictive value
[71,72]. In intermediate-risk women, abbreviated breast MRI yields a lower CDR (7 per 1,000) compared to high-
risk women (29 per 1,000) [53]. Multiple studies have demonstrated similar diagnostic accuracy for abbreviated
protocol MRI compared to conventional full protocol breast MRI [73-75]. The ECOG-ACRIN abbreviated MRI
trial demonstrated a significantly higher CDR for abbreviated breast MRI without and with IV contrast (15 cancers
per 1,000) compared with DBT (6 cancers per 1,000) in women with dense breasts [45]. In addition to dense breasts,
women enrolled in the trial had variable 5 and 10 year risk profiles based upon the Breast Cancer Surveillance
Consortium risk calculator, and 19% reported 1 or more first degree relatives with breast cancer [45].
MRI Breast Without IV Contrast
There is no relevant literature to support the use of breast MRI without IV contrast for screening women at
intermediate risk.
MRI Breast Without IV Contrast Abbreviated
There is no relevant literature to support the use of abbreviated breast MRI without IV contrast for screening women
at intermediate risk.
Sestamibi MBI
Data are limited regarding the use of sestamibi MBI for screening women at intermediate risk. Most studies have
focused upon women with dense breasts and variable risk profiles. Retrospective and prospective studies have
demonstrated similar incremental CDR for sestamibi MBI of 6.5 to 9 over mammography, with a study
demonstrating an incremental CDR of 16.5 per 1,000 in women at increased risk primarily due to family or personal
history of breast cancer [40,47]. Sestamibi MBI demonstrates similar sensitivity, better specificity, and lower recall
rate compared to supplemental screening US in women with dense breasts [47,48].
US Breast
Most studies evaluating the utility of screening with breast US have focused on women with dense breast tissue
with or without other risk factors. Dense breast tissue decreases the sensitivity of mammography [26] and is an
independent risk factor for developing breast cancer [27]. Screening breast US in women with mammographically
dense breasts, including those with risk factors placing them at increased breast cancer risk, identifies predominantly
mammographically occult, small, node-negative invasive tumors with an increased CDR of 1.8 to 4.6 cancers per
1,000 women screened [40,49]. Although supplemental screening US in women with dense breasts results in an
increased CDR, US also increases recall rate, false-positive examinations, and false-positive biopsies [26,49-55].
In women undergoing annual mammography plus annual supplemental screening MRI, the addition of supplemental
screening with US does not identify additional cancers and is therefore not routinely performed.
For supplemental screening recommendations based upon breast density, please refer to the ACR Appropriateness
Criteria
®
topic onSupplemental Breast Cancer Screening Based on Breast Density[10].
The ACRIN 6666 trial enrolled women with dense breast tissue and at least one other breast cancer risk factor [61].
Compared to mammography alone, screening US detected 5.3 cancers per 1,000 in year 1, 3.7 cancers per 1,000 in
years 2 and 3, and resulted in a larger number of false-positive examinations and false-positive biopsies each year
[61]. In a prospective study limited to intermediate-risk women, sensitivity of mammography was 57%, US was
24.5%, and mammography combined with biannual US demonstrated 80.4% sensitivity [76]. In women with a
ACR Appropriateness Criteria
®
11 Female Breast Cancer Screening
personal history of breast cancer, supplemental US screening results in an incremental CDR of 2.4 to 2.9 cancers
per 1,000 examinations over mammography alone; however, US screening has lower specificity [10,66].
Variant 3: Adult female. Breast cancer screening. High risk.
Women considered high risk for breast cancer include those with a >20% to 25% estimated lifetime risk for
developing breast cancer using a validated statistical model. Other groups of high-risk women include those
carrying a pathogenic mutation within certain genes (eg, BRCA1, BRCA2, p53, ATM, CHEK2, PALB2 [77]), first-
degree relatives of these mutation carriers who remain untested themselves, and women with a history of thoracic
or upper abdominal radiation therapy at an early age (<30 years) [78]. Some women with a personal history of
breast cancer may also fit into the high-risk category [3]. Since 2007, published guidelines have recommended that
high-risk women undergo more intensive breast cancer screening regimens, typically beginning at younger ages
[4].
Please reference the ACR Appropriateness Criteria
®
topics onTransgender Breast Cancer Screening” [9],
Supplemental Breast Cancer Screening Based on Breast Density[10], Imaging after Mastectomy and Breast
Reconstruction[11], Imaging after Breast Surgery[12], and Breast Imaging of Pregnant and Lactating Women
[13] in the appropriate clinical context.
Digital Breast Tomosynthesis Screening
DBT displays reconstructed stacked images of the breast in combination with digital mammographic views, which
may be synthetic mammograms reconstructed from the acquired tomosynthesis data set or FFDM. Compared to
FFDM or synthetic mammograms alone, most studies demonstrate that DBT increases CDR and decreases recall
rate [14-22]; although, some studies have not reached statistical significance [23] or have found less compelling
results in subsets of women, such as those with extremely dense breasts [24,25]. Dense breast tissue decreases the
sensitivity of mammography [26] and is an independent risk factor for developing breast cancer [27]. Irrespective
of risk category, meta-analyses have demonstrated an incremental increase in CDR of 1.6 to 3.2 per 1,000 screening
DBT examinations and a 2.2% pooled decrease in recall rate compared to digital mammography [18,29,30].
The degree of breast cancer mortality reduction from screening mammography varies with different screening
regimens. Mortality reduction is greater when screening begins at 40 years of age rather than 45 or 50 years of age
and when screening is done more frequently (annually rather than biennially) [8,31]. Beginning screening at an
earlier age and more frequent screening result in a greater number of imaging studies performed, so these screening
regimens also increase the number of false-positive examinations and biopsies [8,32]. Although randomized
controlled trials of screening mammography did not enroll women >74 years of age, observational studies
demonstrate that some women ≥75 years of age may continue to benefit from screening mammography [8,32].
There is no upper age limit agreed upon for screening mammography [5,6,8,32]. Because mortality reduction from
screening mammography requires years before being fully attained, screening recommendations should be based
upon life expectancy and competing comorbidities, rather than age alone [8,32-34]. Women should continue
screening mammography as long as they remain in overall good health and are willing to undergo the examination
and subsequent testing or biopsy, if an abnormality is identified [5,8].
Within the limited studies of women at elevated risk due to personal and/or family history of breast cancer, DBT
decreased recall rate without a significant increase in CDR compared to FFDM; however, small sample sizes restrict
analyses [3,40].
High-risk women should begin annual screening mammography at 30 years of age or 10 years prior to the youngest
family member who had breast cancer, but generally not before 30 years of age [3]. Approximately one-third of
breast cancers may only be detected on mammography in BRCA2 mutation carriers who are <40 years of age [79].
In some mutation carriers, some referring providers use mammography or DBT beginning at 40 years of age if
patients undergo annual MRI [80]. Women who underwent thoracic or upper abdominal radiation therapy at an
early age (<30 years) should begin screening mammography 8 years after radiation therapy but not before 25 years
of age [3].
Because screening mammography decreases breast cancer mortality, screening mammography or screening DBT
is still performed in women undergoing supplemental screening studies [3,8,35].
Mammography Screening
To date, mammography is the only screening modality shown to decrease breast cancer mortality. Multiple
randomized controlled trials demonstrate that invitation to screening mammography results in at least a 22%
ACR Appropriateness Criteria
®
12 Female Breast Cancer Screening
reduction in breast cancer mortality [35]. For example, after 29 years of follow-up, the Swedish Two-County trial
demonstrated a 27% to 31% reduction in breast cancer mortality in 133,065 women 40 to 74 years of age invited to
screening despite use of single view mammography and the 24 to 33 month interval between subsequent screenings
[1]. Randomized controlled trials of screening mammography in which advanced stage breast cancers decreased by
20% or more demonstrate even greater reductions in breast cancer mortality [8]. Observational studies, including
those from population-based service screening programs, also demonstrate larger reductions in breast cancer
mortality (≥40%) in women who were actually screened [8,35].
In addition to mortality reduction, screening mammography decreases treatment morbidity, because screen-detected
tumors are typically lower stage (eg, smaller and more likely to be node-negative), compared to breast cancers
detected by palpation [2,8]. Despite these benefits, screening mammograms also have risks. The most common
perceived risks include false-positive recalls and biopsies, overdiagnosis [5,7,32], and patient anxiety.
Approximately 10% of screening mammograms result in a recall for additional imaging, although <2% result in a
recommendation for percutaneous biopsy following additional imaging [8]. Overdiagnosis refers to breast cancers
that are detected by screening that would not have otherwise become apparent during the patient’s lifetime. The
reported frequency of overdiagnosis varies widely in the published literature due to important underlying
differences in study methodology. Overdiagnosis estimates that do not account for breast cancer risk, trends in
breast cancer incidence, or lead time bias range from 0% to 54%, whereas adjusted estimates range from 1% to 10%
[36,37]. Overdiagnosis estimates increase with age at screening [36,37]. Although the risks of screening may impact
uptake and adherence to screening mammography, prior research has shown that women value early detection of
breast cancer over false-positives and screening-related
anxiety [8].
Despite the established mortality benefit, published guidelines differ in their recommendations for screening
mammography due to variations in the perceptions of the relative risks and benefits [5,38]. The degree of breast
cancer mortality reduction from screening mammography varies with different screening regimens. Mortality
reduction is greater when screening begins 40 years of age rather than 45 or 50 years of age and when screening is
done more frequently (annually rather than biennially) [8,31]. Annual screening mammography for women 40 to
84 years of age decreases mortality by 40% (12 lives per 1,000 women screened), whereas biennial screening
mammography for women 50 to 74 years of age only decreases mortality by 23% (7 lives per 1,000 women
screened) [32]. Earlier initiation of screening and more frequent screening, result in a greater number of imaging
studies performed, so these screening regimens also increase the number of false-positive examinations and biopsies
[8,32]. Although randomized controlled trials of screening mammography did not enroll women >74 years of age,
observational studies demonstrate that women ≥75 years of age may continue to benefit from screening
mammography [8,32]. There is no upper age limit agreed upon for screening mammography [5,6,8,32]. Because
mortality reduction from screening mammography requires years before being fully attained, screening
recommendations should be based upon life expectancy and competing comorbidities, rather than age alone [8,32-
34]. Women should continue screening mammography as long as they remain in overall good health and are willing
to undergo the examination and subsequent testing or biopsy, if an abnormality is identified [5,8].
For women 40 to 49 years of age, randomized controlled trials and observational studies demonstrate that screening
mammography decreases breast cancer mortality by 15% to 50% [1,8,32,33,39]. Results from the CISNET suggest
that annual screening mammography in women 40 to 49 years of age saves 42% more lives and life-years than
biennial screening due to faster growing tumors in younger women [31]. Women screened between 40 and 49 years
of age are also less likely to require mastectomy or chemotherapy than women diagnosed with palpable tumors [2].
Non-Hispanic Black, Hispanic Black, and Hispanic White women have higher breast cancer mortality than non-
Hispanic White women, and minority women often present at younger ages with more aggressive tumor subtypes
[3,8]. Therefore, decreasing access to screening mammography, especially in women 40 to 49 years of age, may
disproportionately impact minority women.
Annual screening mammography results in a greater reduction in mortality compared to biennial screening [8]. In
women 40 to 84 years of age, annual screening reduces mortality by 40%, compared to a 32% reduction for biennial
screening [32]. With regular screening, interval breast cancers do occur with a higher frequency in women
undergoing biennial or triennial screening compared to annual screening. The sensitivity of mammography is
decreased in some groups of women, including those with dense breasts [40]. Dense breast tissue decreases the
sensitivity of mammography [26] and is an independent risk factor for developing breast cancer [27]. Given the
limitations of mammography and to minimize interval cancers, supplemental screening modalities have been
investigated in women at high risk. Because screening mammography decreases breast cancer mortality, screening
ACR Appropriateness Criteria
®
13 Female Breast Cancer Screening
mammography or screening DBT is still performed in women undergoing supplemental screening studies [3,8,35].
Rather than supplementing screening mammography with additional imaging modalities, some have suggested
limiting women offered screening mammography based upon individual patient risk assessed by various risk
models, breast density, or genetic information such as single-nucleotide polymorphism. However, the randomized
controlled trials demonstrating mortality reduction and most large-scale observational studies enrolled women
based upon age and geographic location, not individual patient risk factors. In one observational study in women
<50 years of age, restricting screening to women with a first-degree family history, extremely dense breast tissue,
or both, would cause 66% of potentially screen-detected cancers to be missed [41].
Numerous studies in high-risk women have evaluated the performance of mammography and supplemental
screening modalities, such as US and MRI. Mammography consistently demonstrates lower sensitivity (25%-69%)
than US or MRI, and high-risk women experience higher interval cancer rates than the general population [3,40].
The combination of mammography with MRI yields the highest sensitivity across high-risk groups of women (91%-
98%) [3,40,81]. Because screening mammography decreases breast cancer mortality, screening mammography or
screening DBT is still performed in women undergoing supplemental screening studies [3,8,35]. High-risk women
should begin annual screening mammography at 30 years of age or 10 years prior to the youngest family member
who had breast cancer, but generally not before 30 years of age [3]. Approximately one-third of breast cancers may
only be detected on mammography in BRCA2 mutation carriers who are <40 years of age [79]. In some mutation
carriers, some referring providers use mammography or DBT beginning at 40 years of age if patients undergo annual
MRI [80]. Women who underwent thoracic or upper abdominal radiation therapy at an early age (<30 years) should
begin screening mammography 8 years after radiation therapy but not before 25 years of age [3].
Mammography With IV Contrast
Data are limited regarding the use of mammography with IV contrast for breast cancer screening in high-risk
women. To date, published studies have predominantly included women with dense breasts and other risk factors
resulting in intermediate or high-risk profiles. Compared to mammography alone, mammography with IV contrast
increases sensitivity and cancer detection (incremental CDR = 6.6-13 per 1,000) in women at elevated risk [57-60].
Mammography with IV contrast may be useful in high-risk women as an alternative to MRI.
MRI Breast Without and With IV Contrast
MRI has a higher CDR than mammography alone, DBT, or mammography/DBT combined with US [61-64]. In
high-risk women, supplemental screening MRI combined with mammography yields a 91% to 98% sensitivity,
although the reported specificity of MRI is typically lower than mammography [40,81]. The incremental CDR of
MRI in elevated-risk women ranges from 8 to 29 per 1,000 women, with higher CDR (26 per 1,000) in BRCA
mutation carriers [61-63,65,66]. Breast MRI detects small, node-negative invasive cancers at earlier tumor stages
compared to mammography, as well as ductal carcinoma in situ [68,69]. Screening MRI also reduces interval
cancers [69]. However, breast MRI has a higher recall rate than mammography (15.1% versus 6.4%) [70], higher
frequency of BI-RADS category 3 assessment than mammography (14.8% versus 11.8%), and a greater frequency
of image-guided biopsies than mammography (11.8 versus 2.4%) [63].
In women with a personal history of breast cancer, early detection of second breast cancers improves survival;
however, mammographic sensitivity is lower, and interval cancer rates are higher, prompting investigations into
supplemental screening regimens in breast cancer survivors [3,40,66]. In women previously diagnosed with breast
cancer [3], a recent meta-analysis estimated a CDR of 9 to 15 per 1,000 breast MRI [67]. Due to heterogeneity in
the risk of second breast cancer diagnoses, recommendations for supplemental screening MRI vary. Based upon
limited modeling data, women with a personal history of breast cancer who were diagnosed before <50 years of age
or women with a personal history of breast cancer and dense breast tissue may have a >20% estimated lifetime risk
of a subsequent breast cancer diagnosis and may therefore be considered high risk, warranting supplemental
screening breast MRI on an annual basis [3]. In a prospective observational study of women 50 years of age who
had undergone breast conservation therapy, supplemental screening MRI increased CDR (8.2 versus 4.4 per 1,000)
but had decreased specificity, compared to mammography [66].
Since 2007, the American Cancer Society has recommended annual breast MRI for breast cancer screening in high-
risk women [4]. The ACR recommends annual breast MRI in high-risk women beginning as early as 25 years of
age [3].
ACR Appropriateness Criteria
®
14 Female Breast Cancer Screening
MRI Breast Without and With IV Contrast Abbreviated
Data are limited regarding the use of abbreviated breast MRI without and with IV contrast for screening in high-
risk women. Following the publication of the American Cancer Society guidelines for supplemental screening breast
MRI in 2007, high-risk women have traditionally undergone conventional full protocol breast MRI without and
with IV contrast [3,4]. However, multiple studies have demonstrated similar diagnostic accuracy for abbreviated
protocol MRI compared to conventional full protocol breast MRI [73-75]. In a study evaluating 3,037 abbreviated
breast MRI in 1,975 high-risk women, the CDR was 29 per 1,000, the interval cancer rate was 0.66 per 1,000, and
all cancers missed by abbreviated breast MRI were node negative early-stage invasive malignancies [72].
MRI Breast Without IV Contrast
There is no relevant literature to support the use of MRI without IV contrast for screening women at high risk.
MRI Breast Without IV Contrast Abbreviated
There is no relevant literature to support the use of abbreviated breast MRI without IV contrast for screening women
at high risk.
Sestamibi MBI
Data are limited regarding the use of sestamibi MBI for screening women at high risk. Most studies have focused
upon women with dense breasts and variable risk profiles. Retrospective and prospective studies have demonstrated
similar incremental CDR for sestamibi MBI of 6.5 to 9 over mammography, with one study demonstrating an
incremental CDR of 16.5 per 1,000 in women at increased risk primarily due to family or personal history of breast
cancer [40,47]. Sestamibi MBI demonstrates similar sensitivity, better specificity, and lower recall rate compared
to supplemental screening US in women with dense breasts [47,48].
US Breast
In high-risk women undergoing annual mammography plus annual supplemental screening MRI, the addition of
supplemental screening with US does not identify additional cancers and is therefore not routinely performed.
Screening US may be useful in high-risk patients as an alternative to MRI. However, high-risk women who do not
undergo supplemental screening MRI should be counseled that the CDR of US is inferior to MRI. MRI has a higher
CDR than mammography, DBT, or mammography/DBT combined with US [61-64]. The ACRIN 6666 trial
enrolled women with elevated breast cancer risk [61]. Compared to mammography alone, screening US detected
5.3 cancers per 1,000 in year 1 and 3.7 cancers per 1,000 in years 2 and 3 and resulted in a larger number of false-
positive examinations and false-positive biopsies each year [61]. After 3 consecutive rounds of mammography plus
US, the incremental CDR of MRI was 14.7 per 1,000, although false-positive examinations also increased [61]. In
a prospective multicenter study of 687 high-risk women who underwent clinical breast examination,
mammography, US, and MRI for screening, the combination of MRI plus mammography maximized the breast
cancers detected [62]. Mammography identified 5 cancers per 1,000 compared to 6 per 1,000 for US, 7.7 per 1,000
for mammography plus US, 14.9 per 1,000 for MRI, 14.9 per 1,000 for MRI plus US, 16 per 1,000 for
mammography plus MRI, and 16 per 1,000 for mammography plus US plus MRI [62].
In a prospective study of BRCA mutation carriers and high-risk women, sensitivity of mammography was 25% and
66% whereas US was 23% and 34%, respectively [76]. In the high-risk group, mammography combined with
biannual US demonstrated 100% sensitivity [76]; however, MRI was not performed. In a subset analysis of BRCA
mutation carriers, MRI sensitivity was 94% [76]. In another study of 529 high-risk women suspected or proven to
carry a deleterious BRCA mutation, the performance of US was also inferior to MRI [82]. The sensitivity of
mammography was 33%, US was 40%, mammography plus US was 49%, and MRI was 91% [82].
In women with a personal history of breast cancer, supplemental US screening results in an incremental CDR of
2.4 to 2.9 cancers per 1,000 examinations over mammography alone; however, US screening has lower specificity
[10,66].
Summary of Recommendations
Variant 1: DBT screening and mammography screening are usually appropriate for breast cancer screening in
an adult woman at average risk. These procedures are alternatives.
Variant 2: DBT screening and mammography screening are usually appropriate for breast cancer screening in
an adult woman at intermediate risk. These procedures are alternatives.
ACR Appropriateness Criteria
®
15 Female Breast Cancer Screening
Variant 3: DBT screening, mammography screening, MRI breast without and with IV contrast, and abbreviated
MRI breast without and with IV contrast are usually appropriate for breast cancer screening in an adult woman
at high risk. DBT screening and mammography screening are alternatives. MRI breast without and with IV
contrast and abbreviated MRI breast without and with IV contrast are alternatives. DBT screening and
mammography screening are complementary to MRI breast without and with IV contrast and abbreviated MRI
breast without and with IV contrast. In adult women at high risk, breast cancer detection on imaging is
maximized with the use of these 2 complementary screening examinations. The panel did not agree on the
recommendation for US breast or mammography with IV contrast, because those imaging modalities should be
reserved for adult women at high risk who cannot undergo MRI screening.
Supporting Documents
The evidence table, literature search, and appendix for this topic are available at https://acsearch.acr.org/list
. The
appendix includes the strength of evidence assessment and the final rating round tabulations for each
recommendation.
For additional information on the Appropriateness Criteria methodology and other supporting documents go to
www.acr.org/ac
.
Appropriateness Category Names and Definitions
Appropriateness Category Name
Appropriateness
Rating
Appropriateness Category Definition
Usually Appropriate 7, 8, or 9
The imaging procedure or treatment is indicated in the
specified clinical scenarios at a favorable risk-benefit
ratio for patients.
May Be Appropriate 4, 5, or 6
The imaging procedure or treatment may be indicated
in the specified clinical scenarios as an alternative to
imaging procedures or treatments with a more
favorable risk-benefit ratio, or the risk-benefit ratio for
patients is equivocal.
May Be Appropriate
(Disagreement)
5
The individual ratings are too dispersed from the panel
median. The different label provides transparency
regarding the panel’s recommendation. “May be
appropriate is the rating category and a rating of 5 is
assigned.
Usually Not Appropriate 1, 2, or 3
The imaging procedure or treatment is unlikely to be
indicated in the specified clinical scenarios, or the
risk-benefit ratio for patients is likely to be
unfavorable.
Relative Radiation Level Information
Potential adverse health effects associated with radiation exposure are an important factor to consider when
selecting the appropriate imaging procedure. Because there is a wide range of radiation exposures associated with
different diagnostic procedures, a relative radiation level (RRL) indication has been included for each imaging
examination. The RRLs are based on effective dose, which is a radiation dose quantity that is used to estimate
population total radiation risk associated with an imaging procedure. Patients in the pediatric age group are at
inherently higher risk from exposure, because of both organ sensitivity and longer life expectancy (relevant to the
long latency that appears to accompany radiation exposure). For these reasons, the RRL dose estimate ranges for
pediatric examinations are lower as compared with those specified for adults (see Table below). Additional
information regarding radiation dose assessment for imaging examinations can be found in the ACR
Appropriateness Criteria
®
Radiation Dose Assessment Introduction document [83].
ACR Appropriateness Criteria
®
16 Female Breast Cancer Screening
Relative Radiation Level Designations
Relative Radiation Level*
Adult Effective Dose Estimate
Range
Pediatric Effective Dose Estimate
Range
O
0 mSv 0 mSv
<0.1 mSv <0.03 mSv
☢☢
0.1-1 mSv 0.03-0.3 mSv
☢☢☢
1-10 mSv 0.3-3 mSv
☢☢☢☢
10-30 mSv 3-10 mSv
☢☢☢☢☢
30-100 mSv 10-30 mSv
*RRL assignments for some of the examinations cannot be made, because the actual patient doses in these procedures vary
as a function of a number of factors (eg, region of the body exposed to ionizing radiation, the imaging guidance that is used).
The RRLs for these examinations are designated as “Varies.”
References
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Years Old With Mammography: What Is the Impact on Treatment Morbidity and Potential Risk Reduction?
American Journal of Roentgenology 2014;202:282-88.
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Than-Average Risk: Updated Recommendations From the ACR. J Am Coll Radiol 2023:[Epub ahead of print].
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. Accessed September
29, 2023.
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83. American College of Radiology. ACR Appropriateness Criteria
®
Radiation Dose Assessment Introduction.
Available at:
https://www.acr.org/-/media/ACR/Files/Appropriateness-
Criteria/RadiationDoseAssessmentIntro.pdf. Accessed September 29, 2023.
The ACR Committee on Appropriateness Criteria and its expert panels have developed criteria for determining appropriate imaging examinations for
diagnosis and treatment of specified medical condition(s). These criteria are intended to guide radiologists, radiation oncologists and referring physicians in
making decisions regarding radiologic imaging and treatment. Generally, the complexity and severity of a patient’s clinical condition should dictate the
selection of appropriate imaging procedures or treatments. Only those examinations generally used for evaluation of the patient’s condition are ranked.
Other imaging studies necessary to evaluate other co-existent diseases or other medical consequences of this condition are not considered in this document.
The availability of equipment or personnel may influence the selection of appropriate imaging procedures or treatments. Imaging techniques classified as
investigational by the FDA have not been considered in developing these criteria; however, study of new equipment and applications should be encouraged.
The ultimate decision regarding the appropriateness of any specific radiologic examination or treatment must be made by the referring physician and
radiologist in light of all the circumstances presented in an individual examination.