Revised 2022

American College of Radiology
ACR Appropriateness Criteria®
Palpable Breast Masses
Variant 1:

Adult female, 40 years of age or older. Palpable breast mass. Initial imaging.
ProcedureAppropriateness Category

Relative Radiation Level

Digital breast tomosynthesis diagnostic

Usually Appropriate

Mammography diagnostic

Usually Appropriate☢☢

US breast

May Be Appropriate

☢☢
O

☢☢

Digital breast tomosynthesis screening

Usually Not Appropriate

Mammography screening

Usually Not Appropriate

Image-guided core biopsy breast

Usually Not Appropriate

VariesImage-guided fine needle aspiration breast

Usually Not Appropriate

Varies

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

O

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

Variant 2:

☢☢

O

☢☢☢
☢☢☢

Adult female, 40 years of age or older. Palpable breast mass. Mammography findings are
suspicious or highly suggestive of malignancy (BI-RADS 4 or 5). Next imaging study.
Procedure

US breast

Appropriateness Category

Relative Radiation Level

Usually Appropriate

O

Image-guided core biopsy breast

Usually Not Appropriate

VariesImage-guided fine needle aspiration breast

Usually Not Appropriate

Varies

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

O

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

Variant 3:

O

☢☢☢
☢☢☢

Adult female, 40 years of age or older. Palpable breast mass. Diagnostic mammography, DBT,
and US findings are probably benign (BI-RADS 3). Next imaging study.
ProcedureAppropriateness Category

Relative Radiation Level

Image-guided core biopsy breast

Usually Not Appropriate

VariesImage-guided fine needle aspiration breast

Usually Not Appropriate

Varies

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

O

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

ACR Appropriateness Criteria®

1

O

☢☢☢
☢☢☢

Palpable Breast Masses

Variant 4:

Adult female, 40 years of age or older. Palpable breast mass. Mammography findings are
benign (BI-RADS 2) at the site of palpable mass. Next imaging study.
Procedure

US breast

Appropriateness Category

Relative Radiation Level

May Be Appropriate

O

Image-guided core biopsy breast

Usually Not Appropriate

VariesImage-guided fine needle aspiration breast

Usually Not Appropriate

Varies

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

O

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

Variant 5:

O

☢☢☢
☢☢☢

Adult female, 40 years of age or older. Palpable breast mass. Mammography findings arenegative (BI-RADS 1). Next imaging study.
Procedure

US breast

Appropriateness Category

Relative Radiation Level

Usually Appropriate

O

Image-guided core biopsy breast

Usually Not Appropriate

VariesImage-guided fine needle aspiration breast

Usually Not Appropriate

Varies

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

O

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

Variant 6:

O

☢☢☢
☢☢☢

Adult female, younger than 30 years of age. Palpable breast mass. Initial imaging.
Procedure

US breast

Appropriateness Category

Relative Radiation Level

Usually Appropriate

O☢☢

Digital breast tomosynthesis diagnostic

Usually Not Appropriate

Digital breast tomosynthesis screening

Usually Not Appropriate

Mammography diagnostic

Usually Not Appropriate

Mammography screening

Usually Not Appropriate

Image-guided core biopsy breast

Usually Not Appropriate

VariesImage-guided fine needle aspiration breast

Usually Not Appropriate

Varies

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

O

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

ACR Appropriateness Criteria®

2

☢☢
☢☢
☢☢

O

☢☢☢
☢☢☢

Palpable Breast Masses

Variant 7:

Adult female, younger than 30 years of age. Palpable breast mass. US findings are suspicious
or highly suggestive of malignancy (BI-RADS 4 or 5). Next imaging study.
ProcedureAppropriateness Category

Relative Radiation Level

Digital breast tomosynthesis diagnostic

Usually Appropriate

Mammography diagnostic

Usually Appropriate☢☢

Image-guided core biopsy breast

Usually Appropriate

VariesMay Be Appropriate (Disagreement)

VariesDigital breast tomosynthesis screening

Usually Not Appropriate

Mammography screening

Usually Not Appropriate☢☢

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

Image-guided fine needle aspiration breast

Variant 8:

☢☢

☢☢
O
O

☢☢☢
☢☢☢

Adult female, younger than 30 years of age. Palpable breast mass. US findings probably
benign (BI-RADS 3). Next imaging study.
ProcedureAppropriateness Category

Relative Radiation Level

Digital breast tomosynthesis diagnostic

Usually Not Appropriate

Digital breast tomosynthesis screening

Usually Not Appropriate☢☢

Mammography diagnostic

Usually Not Appropriate

Mammography screening

Usually Not Appropriate

Image-guided core biopsy breast

Usually Not Appropriate

VariesImage-guided fine needle aspiration breast

Usually Not Appropriate

Varies

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

O

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

ACR Appropriateness Criteria®

3

☢☢
☢☢
☢☢

O

☢☢☢
☢☢☢

Palpable Breast Masses

Variant 9:

Adult female, younger than 30 years of age. Palpable breast mass. US findings benign (BIRADS 2). Next imaging study.
ProcedureAppropriateness Category

Relative Radiation Level

Digital breast tomosynthesis diagnostic

Usually Not Appropriate

Digital breast tomosynthesis screening

Usually Not Appropriate☢☢

Mammography diagnostic

Usually Not Appropriate

Mammography screening

Usually Not Appropriate

Image-guided core biopsy breast

Usually Not Appropriate

VariesImage-guided fine needle aspiration breast

Usually Not Appropriate

Varies

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

O

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

Variant 10:

☢☢
☢☢
☢☢

O

☢☢☢
☢☢☢

Adult female, younger than 30 years of age. Palpable breast mass. US findings negative (BIRADS 1). Next imaging study.
ProcedureAppropriateness Category

Relative Radiation Level

Digital breast tomosynthesis diagnostic

Usually Not Appropriate

Digital breast tomosynthesis screening

Usually Not Appropriate☢☢

Mammography diagnostic

Usually Not Appropriate

Mammography screening

Usually Not Appropriate

Image-guided core biopsy breast

Usually Not Appropriate

VariesImage-guided fine needle aspiration breast

Usually Not Appropriate

Varies

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

O

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

ACR Appropriateness Criteria®

4

☢☢
☢☢
☢☢

O

☢☢☢
☢☢☢

Palpable Breast Masses

Variant 11:

Adult female, 30 to 39 years of age. Palpable breast mass. Initial imaging.
ProcedureAppropriateness Category

Relative Radiation Level

US breast

Usually Appropriate

Digital breast tomosynthesis diagnostic

Usually AppropriateO

Mammography diagnostic

Usually Appropriate

☢☢
☢☢
☢☢

Digital breast tomosynthesis screening

Usually Not Appropriate

Mammography screening

Usually Not Appropriate

Image-guided core biopsy breast

Usually Not Appropriate

VariesImage-guided fine needle aspiration breast

Usually Not Appropriate

Varies

MRI breast without and with IV contrast

Usually Not Appropriate

MRI breast without IV contrast

Usually Not Appropriate

O

Sestamibi MBI

Usually Not Appropriate

FDG-PET breast dedicated

Usually Not Appropriate

ACR Appropriateness Criteria®

5

☢☢

O

☢☢☢
☢☢☢

Palpable Breast Masses

PALPABLE BREAST MASSES
Expert Panel on Breast Imaging: Katherine A. Klein, MD a; Maddi Kocher, MDb; Ana P. Lourenco, MDc;
Bethany L. Niell, MD, PhDd; Debbie L. Bennett, MDe; Alison Chetlen, DOf; Phoebe Freer, MDg;
Lillian K. Ivansco, MD, MPHh; Maxine S. Jochelson, MDi; Mallory E. Kremer, MDj; Sharp F. Malak, MD, MPHk;
Marion McCrary, MDl; Tejas S. Mehta, MD, MPHm; Colleen H. Neal, MDn; Andrea Porpiglia, MDo;
Gary A. Ulaner, MD, PhDp; Linda Moy, MD.q
Summary of Literature Review
Introduction/Background
Breast cancer remains the most common female malignancy (excluding skin) and the second leading cause of female
cancer death in the United States, with a woman’s lifetime risk of breast cancer at approximately 12.8%. Palpablebreast masses are more commonly from benign causes; however, a palpable mass is the most common symptom
associated with cancer, and palpable cancers tend to be more aggressive with poorer prognoses compared withscreen-detected cancers [1-3]. Palpable breast masses may present in various circumstances: during routine breast
self-examination or clinical breast examination; between regular mammographic screens; before baseline
mammogram; or after prolonged abstention from mammography due to advanced age or personal choice [4].
Detection and characterization of a breast mass at physical examination may be difficult, but masses are generally
asymmetrical in relation to the other breast, distinct from the surrounding tissues, and 3-D. Malignant masses cannot
be reliably differentiated from benign by physical examination, even among experienced clinicians [5]. Moresuspicious features of a cancerous mass may include firmness and fixation due to attachments to the skin or deepfascia with dimpling or nipple retraction. In contrast, benign masses typically are mobile and have discrete, welldefined margins, as well as a soft or rubbery texture. Cysts cannot reliably be distinguished from solid breast masses
by palpation. In one study, only 58% of 66 palpable cysts were correctly identified by physical examination [6].
Imaging evaluation is necessary to adequately characterize a palpable breast mass. After thorough clinical breast
examination, usually by the referring clinician or by a specialist breast clinician, the radiologist must be able toestablish concordance between the clinically detected mass and the imaging features at that location [2]. The
negative predictive value of mammography with ultrasound (US) in the context of a palpable mass ranges from
97.4% to 100% [7-10]. Nevertheless, negative imaging evaluation should not deter biopsy when a strongly
suspicious finding is present on physical examination.
Initial Imaging Definition
Initial imaging is defined as imaging at the beginning of the care episode for the medical condition defined by thevariant. More than one procedure can be considered usually appropriate in the initial imaging evaluation when:•

There are procedures that are equivalent alternatives (ie, only one procedure will be ordered toprovide the clinical information to effectively manage the patient’s care)
OR•

There are complementary procedures (ie, more than one procedure is ordered as a set or
simultaneously where each procedure provides unique clinical information to effectively manage
the patient’s care).

a
University of Michigan, Ann Arbor, Michigan. bResearch Author, Duke University Medical Center, Durham, North Carolina. cPanel Chair, Alpert Medical
School of Brown University, Providence, Rhode Island. dPanel Vice-Chair, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. eWashington
University School of Medicine, Saint Louis, Missouri. fPenn State Health Hershey Medical Center, Hershey, Pennsylvania. gUniversity of Utah, Salt Lake
City, Utah. hKaiser Permanente, Atlanta, Georgia. iMemorial Sloan Kettering Cancer Center, New York, New York. jUniversity of Washington, Seattle,
Washington; American College of Obstetricians and Gynecologists. kSt. Bernards Healthcare, Jonesboro, Arkansas. lDuke Signature Care, Durham, North
Carolina; American College of Physicians. mUMass Memorial Medical Center/UMass Chan Medical School, Worcester, Massachusetts. nProMedica Breast
Care, Toledo, Ohio. oFox Chase Cancer Center, Philadelphia, Pennsylvania; American College of Surgeons. pHoag Family Cancer Institute, Newport Beach,
California and University of Southern California, Los Angeles, California; Commission on Nuclear Medicine and Molecular Imaging. qSpecialty Chair, NYU
Clinical Cancer Center, New York, New York.
The American College of Radiology seeks and encourages collaboration with other organizations on the development of the ACR AppropriatenessCriteria 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: publications@acr.org

ACR Appropriateness Criteria®

6Palpable Breast Masses

Discussion of Procedures by Variant
Variant 1: Adult female, 40 years of age or older. Palpable breast mass. Initial imaging.
Digital Breast Tomosynthesis Diagnostic
Diagnostic digital breast tomosynthesis (DBT) should be used for initial imaging evaluation. A small radio-opaquemarker is placed on the skin over the palpable finding to identify its location. Several prior studies have shown the
diagnostic accuracy of DBT is equivalent to or better than supplemental diagnostic mammographic views in theworkup of women with clinical signs and symptoms and in women recalled from screening [11-14]. The added
features of planar imaging and thin-section reconstructions allow further assessment of potential false-positive
findings. In a recent study, DBT provided similarly accurate diagnostic results as compared with digital
mammography (DM) in women with palpable breast masses for detecting breast cancer using either combination
DM with DBT (DM/DBT) or DM alone [15]. Several small studies, which specifically included women presenting
with clinical symptoms including palpable lumps, demonstrated increased accuracy on combination DM/DBT
compared with DM alone [13,16,17]. Additionally, it was demonstrated that DBT may improve lesion detection
and characterization with higher conspicuity scores as compared with conventional DM imaging, particularly forcancers presenting as spiculated masses and distortions [17].
Digital Breast Tomosynthesis Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening DBT, with or without
DM, is not useful as the initial imaging study. Screening mammography is provided to women without signs or
symptoms of breast disease.
FDG-PET Breast Dedicated
There is no relevant literature to support the use of fluorine-18-2-fluoro-2-deoxy-D-glucose (FDG)-PET breast
dedicated in the initial evaluation of a woman presenting with a palpable mass [2].
Image-Guided Core Biopsy Breast
There is no relevant literature to support the use of image-guided core biopsy in the initial evaluation of a woman
presenting with a palpable mass. Because many breast masses may not exhibit distinctive physical findings, imaging
evaluation is necessary in almost all patients ≥40 years of age to characterize the palpable lesion and screen theremainder of each breast for additional lesions. It is preferable for imaging to occur before biopsy because changes
related to the biopsy may confuse, alter, obscure, and/or limit image interpretation. However, negative imaging
evaluation should not deter biopsy when a strongly suspicious finding is present on physical examination. There is
no relevant literature to support the use of image-guided core biopsy in the initial evaluation of women ≥40 yearsof age with palpable mass.
Image-Guided Fine Needle Aspiration Breast
There is no relevant literature to support the use of image-guided fine needle aspiration (FNA) in the initial
evaluation of a woman presenting with a palpable mass. Because many breast masses may not exhibit distinctive
physical findings, imaging evaluation is necessary in almost all cases to characterize the palpable lesion and screen
the remainder of each breast for additional lesions. It is preferable for imaging to occur before biopsy becausechanges related to the biopsy may confuse, alter, obscure, and/or limit image interpretation. There is no relevant
literature to support the use of the use of image-guided FNA biopsy (FNAB) in the initial evaluation of women ≥40
years of age with palpable mass.
Mammography Diagnostic
Mammography should be using for initial imaging of a palpable breast mass in women ≥40 years of age. It is
performed under the direct supervision of a radiologist and usually consists at a minimum of craniocaudal andmediolateral oblique views of each breast, enabling screening of the entire breast for additional lesions. The
mammogram may only include the ipsilateral breast if the patient has had a recent bilateral mammogram (within
the last 3 to 6 months). A small radio-opaque marker is placed on the skin over the palpable finding to identify its
location. Spot compression views obtained with or without magnification or tangential views are often obtained to
specifically evaluate the clinical finding. Supplemental mammographic views may also be needed to clarify thefeatures or location of a mammographic lesion, including craniocaudal exaggerated, cleavage, step-oblique, and
90° lateral views.
In several series evaluating palpable breast abnormalities [18-20], the sensitivity of mammography alone was 86%
to 91%. Mammography likely does not need to be repeated if it was performed within the past 6 months [21]. This
ACR Appropriateness Criteria®

7

Palpable Breast Masses

modality may be particularly useful in women with almost entirely fatty breasts, in which mammography alone wasshown to have a high sensitivity (96%) and specificity (93%) in the evaluation of palpable breast masses [22].
Mammography Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening mammography is notuseful as the initial imaging study. Screening mammography is provided to women without signs or symptoms ofbreast disease.
MRI Breast
There is no relevant literature to support the use of MRI breast with or without intravenous (IV) contrast in theinitial evaluation of a woman presenting with a palpable mass [2,23-25].
Sestamibi MBI
There is no relevant literature to support the use of Tc-99m sestamibi molecular breast imaging (MBI) in the initial
evaluation of a woman presenting with a palpable mass.
US Breast
US may be considered as an initial means of imaging if the patient has had a recent negative mammogram within
the past 6 months. In a study of women presenting with a palpable breast mass with a negative mammogram within
the previous 6 to 12 months, US detected a finding in 50.3% of 311 cases, whereas repeat mammography detecteda change in 12.9% of cases [21]. US is more frequently used following DBT/mammography in this age group [2,26](see Variants 2, 3, and 5). The negative predictive value of mammography with US in the context of a palpablemass ranges from 97.4% to 100% [7-9].
Variant 2: Adult female, 40 years of age or older. Palpable breast mass. Mammography findings are
suspicious or highly suggestive of malignancy (BI-RADS 4 or 5). Next imaging study.
FDG-PET Breast Dedicated
There is no relevant literature to support the use of FDG-PET breast dedicated as the next step in evaluating a
palpable mass in the context of a suspicious mammographic finding [2].
Image-Guided Core Biopsy Breast
It is preferable for imaging to occur before biopsy because changes related to the biopsy may confuse, alter, obscure,
and/or limit image interpretation. If a mammographically suspicious lesion is identified that correlates with thepalpable mass, US is recommended as the next step in evaluation before image-guided core biopsy is pursued.
However, the lack of sonographic correlate should not deter biopsy of a suspicious mammographic or DBT
abnormality in this setting. Core biopsy is superior to FNAB in terms of sensitivity, specificity, and correct
histological grading of palpable masses [27]. In addition, core biopsy allows for ready evaluation of tumor receptor
status. When a mammographically or DBT-detected suspicious lesion is identified that correlates with a palpablemass, biopsy is warranted. If a lesion is only identified on mammography or DBT, mammographically or DBTguided core biopsy may be pursued [28,29]. If the lesion can be seen with US, US-guided biopsy may be pursued[30]. At image-guided biopsy, a marker clip is placed, and a postbiopsy diagnostic mammogram confirms that the
US and mammographic findings correlate. Similarly, a postbiopsy DBT confirms that the US and DBT findings
correlate. US-guided core biopsy is also usually more easily tolerated because of a lack of breast compression andmay allow biopsy of lesions difficult to access stereotactically (eg, far posterior lesions or axillary lesions) [30].
Image-Guided Fine Needle Aspiration Breast
It is preferable for imaging to occur before biopsy because changes related to the biopsy may confuse, alter, obscure,
and/or limit image interpretation. If a mammographically suspicious lesion is identified that correlates with thepalpable mass, US is recommended as the next step in evaluation before image-guided FNA is pursued. However,the lack of sonographic correlate should not deter biopsy of a suspicious mammographic or DBT abnormality inthis setting. Core biopsy is superior to FNAB in terms of sensitivity, specificity, and correct histological grading of
palpable masses [27]. In addition, core biopsy allows for ready evaluation of tumor receptor status. An additional
consideration of FNAB over a core biopsy may be the faster turnover time for a pathology diagnosis without adifference in time to treatment [31]. At US-guided FNA, a marker clip is placed and a postprocedure mammogram
confirms that the US and mammographic findings correlate. Similarly, a postprocedure DBT confirms that the US
and DBT findings correlate.

ACR Appropriateness Criteria®

8Palpable Breast Masses

MRI Breast
There is no relevant literature to support the use of MRI of the breast with or without IV contrast as the next step in
evaluating a palpable mass in the context of a suspicious mammographic finding [2,23-25]. If malignancy issubsequently established by biopsy, MRI may be useful in delineating extent of disease in certain circumstances[32].
Sestamibi MBI
There is no relevant literature to support the use of the use of Tc-99m sestamibi MBI as the next step in evaluatinga palpable mass in the context of a suspicious mammographic finding.
US Breast
US may be helpful in characterizing a suspicious mammographic finding [33]. In a study of women presenting withpalpable breast thickening, the sensitivity of diagnostic mammography for invasive cancer detection was 60%,
whereas the sensitivity of US alone was 100% [34].
Breast US should be performed using a high-resolution, real-time linear array scanner with an adjustable focal zone
and a transducer with a minimum center frequency of 12 MHz [35]. Some mammographers also perform screening
US of the remainder of the ipsilateral breast and the contralateral breast in the setting of a suspicious finding [33].
If there is no sonographic correlate for a suspicious mammographic finding, tissue sampling (stereotactic biopsy)
should be guided by the suspicious mammographic finding. If there is no sonographic correlate for a suspicious
DBT finding, tissue sampling (tomosynthesis-guided biopsy) should be guided by the suspicious DBT finding.
Variant 3: Adult female, 40 years of age or older. Palpable breast mass. Diagnostic mammography, DBT,
and US findings are probably benign (BI-RADS 3). Next imaging study.
FDG-PET Breast Dedicated
There is no relevant literature to support the use of FDG-PET breast dedicated as the next step in evaluating a
palpable mass in the context of a probably benign mammographic finding for women ≥40 years of age [2].
Image-Guided Core Biopsy Breast
If a palpable mass has probably benign features as identified on mammogram and/or US, imaging follow-up may
be appropriate. However, if a mass is new on imaging or increasing by >20% in volume or >20% in each diameterin a 6-month period, the mass is considered suspicious, and image-guided biopsy is recommended [36]. Core biopsy
is superior to FNAB in terms of sensitivity, specificity, and correct histological grading of palpable masses [27]. In
addition, there are certain cases in which biopsy may be performed even on probably benign lesions. For example,
BI-RADS 3 lesions in high-risk patients, patients awaiting organ transplant, patients with known synchronous
cancers, or patients trying to get pregnant may be appropriate for tissue sampling. In addition, situations in whichbiopsy may alleviate extreme patient anxiety may prompt tissue sampling [30,37]. If an image-guided biopsy is
pursued, a marker clip is placed and a postbiopsy mammogram/DBT confirms that the clip placement andmammographic/DBT findings correlate.
Image-Guided Fine Needle Aspiration Breast
If a palpable mass has probably benign features as identified on mammogram and/or US, imaging follow-up may
be appropriate. However, if a mass is new on imaging or increasing by >20% in volume or >20% in each diameterin a 6-month period, image-guided biopsy is recommended [36]. In addition, there are certain cases in which biopsy
may be performed even on probably benign lesions. For example, BI-RADS 3 lesions in high-risk patients, patients
awaiting organ transplant, patients with known synchronous cancers, or patients trying to get pregnant may beappropriate for tissue sampling. In addition, situations in which biopsy may alleviate extreme patient anxiety may
prompt tissue sampling [30,37]. Large series have demonstrated core biopsy is superior to FNAB in terms ofsensitivity, specificity, and correct histological grading of palpable masses [27]. In addition, core biopsy allows forready evaluation of tumor receptor status. FNAB; however, may allow a faster turnover time as compared with core
biopsy for a pathology diagnosis without a difference in time to treatment [31]. At image-guided FNA, a marker
clip is placed and a postprocedure mammogram/DBT confirms that the marker clip and mammographic/DBT
findings correlate.
MRI Breast
There is no relevant literature to support the use of the use of MRI of the breast with or without IV contrast as thenext step in evaluating a palpable mass in the context of a probably benign mammographic finding for women ≥40
years of age [2,23-25].
ACR Appropriateness Criteria®

9Palpable Breast Masses

Sestamibi MBI
There is no relevant literature to support the use of the use of Tc-99m sestamibi MBI as the next step in evaluatinga palpable mass in the context of a probably benign mammographic finding for women ≥40 years of age.
Variant 4: Adult female, 40 years of age or older. Palpable breast mass. Mammography findings are benign(BI-RADS 2) at the site of palpable mass. Next imaging study.
FDG-PET Breast Dedicated
There is no relevant literature to support the use of FDG-PET breast dedicated as the next step in evaluating a
palpable mass in the context of a benign mammographic finding [2].
Image-Guided Core Biopsy Breast
There is no relevant literature to support the use of image-guided core biopsy breast as the next step in evaluating a
palpable mass in the context of a benign mammographic finding.
Image-Guided Fine Needle Aspiration Breast
There is no relevant literature to support the use of image-guided FNAB as the next step in evaluating a palpablemass in the context of a benign mammographic finding. However, image-guided aspiration can be considered for
symptomatic relief of a palpable simple cyst.
MRI Breast
There is no relevant literature to support the use of MRI of the breast with or without IV contrast of the breast as
the next step in evaluating a palpable mass in the context of a benign mammographic finding.
Sestamibi MBI
There is no relevant literature to support the use of Tc-99m sestamibi MBI as the next step in evaluating a palpablemass in the context of a benign mammographic finding.
US Breast
When the mammogram shows a definite benign mass (eg, lymph node, hamartoma, lipoma, calcified fibroadenoma,or oil cyst), US is not necessary as long as the benign mass identified on mammography is a definitive correlate of
the clinical finding.
If correlation between the mammographic finding and the palpable lesion is uncertain, US is useful. US is preferably
targeted specifically to the palpable finding [33]. When both mammography and US are negative or benign in theevaluation of a palpable breast mass, the negative predictive value exceeds 97% [8,9,38]. Together, these imaging
modalities can be reassuring when the physical examination is not highly suspicious and clinical follow-up isplanned. However, a suspicious physical examination should prompt biopsy regardless of benign imaging findings[38].
Variant 5: Adult female, 40 years of age or older. Palpable breast mass. Mammography findings are negative(BI-RADS 1). Next imaging study.
FDG-PET Breast Dedicated
There is no relevant literature to support the use of FDG-PET breast dedicated as the next step in the evaluation ofa woman presenting with a negative mammogram and a palpable mass [2].
Image-Guided Core Biopsy Breast
There is no relevant literature to support the use of image-guided core biopsy as the next step in the evaluation of awoman presenting with a negative mammogram and a palpable mass. US should be performed, and if a suspicious
correlate is identified, then US-guided core biopsy is recommended. However, a suspicious physical examination
should prompt biopsy guided by palpation, regardless of negative imaging findings [38].
Image-Guided Fine Needle Aspiration Breast
There is no relevant literature to support the use of image-guided FNAB as the next step in the evaluation of awoman presenting with a negative mammogram and a palpable mass. US should be performed, and if a suspicious
correlate is identified, then US-guided core biopsy is recommended. However, a suspicious physical examination
should prompt biopsy guided by palpation, regardless of negative imaging findings [38].
MRI Breast
MRI of the breast with or without IV contrast for women with a palpable mass and negative mammography is notrecommended as the next imaging study [2,23-25]. US should be performed next [8,9,19].
ACR Appropriateness Criteria®

10

Palpable Breast Masses

Sestamibi MBI
There is no relevant literature to support the use of the use of Tc-99m sestamibi MBI as the next step in theevaluation of a woman presenting with a negative mammogram and a palpable mass.
US Breast
A major advantage of US is the ability to directly correlate the clinical and imaging findings. The use of multiple
modalities in diagnosing palpable masses has been advocated as a measure to increase the true-positive rate. In 3
series evaluating palpable breast abnormalities [18-20], the sensitivity of mammography was 86% to 91%. The
addition of US detects 93% to 100% of cancers [8,9,19]. The addition of US to mammography may also improvedetection of a benign etiology for a palpable finding and may also identify lesions that are mammographically occult[26]. In a series, 40% of benign palpable masses were identified only on US [20]. In another study of 375 palpablemasses in 320 women, 68.8% of the masses (n = 258) were only identified with US and were typically oval (n =275, 73.3%) and hypoechoic (n = 336 in 372 US examinations, 90.3%) [39]. When both mammography and US are
negative or benign in the evaluation of a palpable breast mass, the negative predictive value is very high, more than
97% [8,9,38,40]. Together, these imaging modalities can be reassuring when the physical examination is not highly
suspicious and clinical follow-up is planned.
If almost entirely fatty tissue is identified in the palpable region of concern, US may not be necessary [2]. In a study
that included 323 palpable masses in 271 women with almost entirely fatty tissue on diagnostic mammography,
mammography alone yielded a negative predictive value of 99.6% [22]. Of the 294 (91%) of women with almost
entirely fatty breasts who also underwent targeted US for the evaluation of palpable symptoms, US yielded 11 falsepositives and 8 benign correlates at sites with no mammographic findings [22].
Variant 6: Adult female, younger than 30 years of age. Palpable breast mass. Initial imaging.
Digital Breast Tomosynthesis Diagnostic
Because of the low incidence of breast cancer (<1%) in younger women, the recommended initial imaging differsfrom older patients [41-44]. Younger women tend to have relatively denser breast tissue [45], which is associatedwith decreased mammographic/DBT sensitivity [46]. DBT is not useful as the initial imaging modality in younger
women.
Digital Breast Tomosynthesis Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening DBT, with or without
DM, is not useful as the initial imaging study. Screening mammography is provided to women without signs or
symptoms of breast disease.
FDG-PET Breast Dedicated
There is no relevant literature to support the use of FDG-PET breast dedicated as the initial imaging workup in
women <30 years of age with a palpable mass [2].
Image-Guided Core Biopsy Breast
There is no relevant literature to support the use of image-guided core biopsy as the initial imaging workup in
women <30 years of age with a palpable mass.
Image-Guided Fine Needle Aspiration Breast
There is no relevant literature to support the use of image-guided FNAB as the initial imaging workup in women<30 years of age with a palpable mass.
Mammography Diagnostic
Because of the low incidence of breast cancer (<1%) in younger women, the recommended initial imaging differsfrom older patients [41-44]. Younger women tend to have relatively denser breast tissue [45], which is associatedwith decreased mammographic/DBT sensitivity [46]. Most benign lesions in young women are not visualized on
mammography [41,43]. Diagnostic mammography is not useful as the initial imaging modality in younger women.
Mammography Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening mammography is notuseful as the initial imaging study. Screening mammography is provided to women without signs or symptoms ofbreast disease.

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MRI Breast
There is no relevant literature to support the use of the use of MRI of the breast with or without IV contrast as theinitial imaging workup in women <30 years of age with a palpable mass [2,23-25].
Sestamibi MBI
There is no relevant literature to support the use of the use of Tc-99m sestamibi MBI as the initial imaging workup
in women <30 years of age with a palpable mass.
US Breast
The probability of a woman developing breast cancer increases with age; a woman has a 1 in 53 chance ofdeveloping invasive breast cancer from birth to age 49 years compared with a 1 in 15 chance at ≥70 years of age[47]. Diagnostic mammography is useful as the initial examination in the evaluation of a palpable breast finding for
women aged ≥40 years of age. However, because of the low incidence of breast cancer (<1%) in younger women,
their imaging evaluation differs from that performed for older patients [41-44]. In addition, most benign lesions inyoung women are not visualized on mammography [41,43], and US is therefore used as the initial imaging modality
in younger women. US is preferably targeted specifically to the palpable finding [33]. As with all age-related
guidelines, pertinent clinical factors such as family history should be used to determine appropriate patient care.
Variant 7: Adult female, younger than 30 years of age. Palpable breast mass. US findings are suspicious or
highly suggestive of malignancy (BI-RADS 4 or 5). Next imaging study.
Digital Breast Tomosynthesis Diagnostic
DBT may be useful in a woman <30 years of age with a suspicious sonographic finding that correlates to a palpablemass. DBT may demonstrate findings not readily detected at US (calcifications or subtle architectural distortion);
this may provide a more accurate assessment of the extent of disease in the ipsilateral breast and can identify
contralateral lesions as well. In addition, DBT may have relatively high diagnostic accuracy in dense breast tissue,
often encountered in younger patients [48,49].
Digital Breast Tomosynthesis Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening DBT, with or without
DM, is not useful as the next imaging study. Screening mammography is provided to women without signs or
symptoms of breast disease.
FDG-PET Breast Dedicated
There is no relevant literature to support the use of FDG-PET breast dedicated as the next step in evaluating a
palpable mass with suspicious sonographic features in women <30 years of age [2].
Image-Guided Core Biopsy Breast
If a suspicious mass has been identified on US, tissue sampling (US guided) is warranted. It may be appropriate toproceed directly to image-guided biopsy if a palpable lesion has suspicious features on US followed by placementof a biopsy clip. If US findings are particularly worrisome for malignancy, diagnostic mammography or DBT may
be performed prior to tissue sampling to delineate disease extent (eg, calcifications extending beyond the marginsof the US-identified solid mass) and identify any additional suspicious findings in the ipsilateral or contralateralbreast. Core-needle biopsy has been shown in large series to be superior to FNA in terms of sensitivity, specificity,and correct histological grading [27]. Some practices have had good results using FNAB, but this may be facility
specific, and a lower threshold for radiologic-pathologic discordance may need to be applied [50,51].
Image-Guided Fine Needle Aspiration Breast
If a suspicious mass has been identified on US, tissue sampling (US guided) is warranted. It may be appropriate toproceed directly to image-guided biopsy if a palpable lesion has suspicious features on US. If US findings are
particularly worrisome for malignancy, diagnostic mammography or DBT may be performed before tissue sampling
to delineate disease extent (eg, calcifications extending beyond the margins of the US-identified solid mass) andidentify any additional suspicious findings in the ipsilateral or contralateral breast. Core-needle biopsy has beenshown in large series to be superior to FNA in terms of sensitivity, specificity, and correct histological grading [27].
Some practices have had good results using FNAB, but this may be facility specific, and a lower threshold forradiologic-pathologic discordance may need to be applied [50,51]. US-guided FNAB may be preferred over core
biopsy in rare situations but should be used judiciously.

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Mammography Diagnostic
Mammography may be useful in a woman <30 years of age with a suspicious sonographic finding that correlates toa palpable mass. If US findings are particularly worrisome for malignancy, mammography diagnostic or diagnostic
DBT would usually be performed before tissue sampling to identify any additional suspicious findings and/or
delineate the extent of disease (eg, calcifications extending beyond the margins of the US-identified solid mass) in
the ipsilateral breast. Mammography diagnostic is recommended as a prebiopsy assessment in cases in which cancer
is strongly suspected clinically [41].
Mammography Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening mammography is notuseful as the next imaging study. Screening mammography is provided to women without signs or symptoms ofbreast disease.
MRI Breast
There is no relevant literature to support the use of the use of MRI of the breast with or without IV contrast as thenext step in evaluating a palpable mass with suspicious sonographic features in women <30 years of age [2,23-25].
Sestamibi MBI
There is no relevant literature to support the use of the use of Tc-99m sestamibi MBI as the next step in evaluatinga palpable mass with suspicious sonographic features in women <30 years of age.
Variant 8: Adult female, younger than 30 years of age. Palpable breast mass. US findings probably benign(BI-RADS 3). Next imaging study.
Digital Breast Tomosynthesis Diagnostic
If a correlate for a palpable mass has been identified on US and is probably benign, there is no indication for DBT
to further evaluate the palpable mass in women <30 years of age.
Digital Breast Tomosynthesis Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening DBT, with or without
DM, is unnecessary for imaging surveillance. Screening mammography is provided to women without signs or
symptoms of breast disease.
FDG-PET Breast Dedicated
There is no relevant literature to support the use of FDG-PET breast dedicated in women <30 years of age withprobably benign sonographic findings in the setting of a palpable mass [2].
Image-Guided Core Biopsy Breast
If a palpable mass has probably benign features as identified on US, US follow-up is recommended. However,image-guided core biopsy may be performed after complete imaging assessment in some cases. For example, BIRADS 3 lesions in high-risk patients, patients awaiting organ transplant, patients with known synchronous cancers,
or patients trying to get pregnant may be appropriate for biopsy instead of imaging follow-up. In addition, situations
in which biopsy may alleviate extreme patient anxiety may prompt tissue sampling and a biopsy marker clip shouldbe placed [30].
Image-Guided Fine Needle Aspiration Breast
If a palpable mass has probably benign features as identified on US, US follow-up is recommended. Image-guided
FNAB may be performed after complete imaging assessment in some cases. For example, BI-RADS 3 lesions inhigh-risk patients, patients awaiting organ transplant, patients with known synchronous cancers, or patients trying
to get pregnant may be appropriate for tissue sampling. In addition, situations in which biopsy may alleviate extreme
patient anxiety may prompt tissue sampling, and a biopsy marker clip should be placed [30]. However, large series
demonstrate that core biopsy is superior to FNAB in terms of sensitivity, specificity, and correct histological gradingof palpable masses [27]. In addition, core biopsy allows for ready evaluation of tumor receptor status. US-guided
FNAB may be preferred in rare situations (lesion abuts an implant).
Mammography Diagnostic
If a correlate for a palpable mass has been identified on US and is probably benign, there is no indication for
diagnostic mammography to further evaluate the palpable mass in women <30 years of age.

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Mammography Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening mammography is
unnecessary for imaging surveillance. Screening mammography is provided to women without signs or symptomsof breast disease.
MRI Breast
There is no relevant literature to support the use of the use of MRI of the breast with or without IV contrast in
women <30 years of age with probably benign sonographic findings in the setting of a palpable mass [2,23-25].
Sestamibi MBI
There is no relevant literature to support the use of the use of Tc-99m sestamibi MBI in women <30 years of age
with probably benign sonographic findings in the setting of a palpable mass.
Variant 9: Adult female, younger than 30 years of age. Palpable breast mass. US findings benign (BI-RADS
2). Next imaging study.
Digital Breast Tomosynthesis Diagnostic
If a benign entity has been found on US and is the definitive correlate for a palpable mass, there is no role for further
evaluation with diagnostic DBT in women <30 years of age.
Digital Breast Tomosynthesis Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening DBT, with or without
DM, is unnecessary for confirmation of benignity. Screening mammography is provided to women without signs
or symptoms of breast disease.
FDG-PET Breast Dedicated
If a benign entity has been found on US and is the definitive correlate for a palpable mass, there is no role for FDGPET breast dedicated in women <30 years of age [2].
Image-Guided Core Biopsy Breast
If a benign entity has been found on US and is the definitive correlate for a palpable mass, there is no role for tissue
sampling. The likelihood of a palpable mass in a young woman that is benign on both clinical examination and US
resulting in a cancer is extremely low; one study prospectively evaluating US-guided core biopsy in 248 young
women <25 years of age with clinically benign masses and predominantly benign findings found no cancers in thisgroup [52].
Image-Guided Fine Needle Aspiration Breast
If a benign entity has been found on US and is the definitive correlate for a palpable mass, there is no role for imageguided FNAB in women <30 years of age.
Mammography Diagnostic
If a benign entity has been found on US and is the definitive correlate for a palpable mass, there is no role for further
evaluation with diagnostic mammography in women <30 years of age.
Mammography Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening mammography is
unnecessary for confirmation of benignity. Screening mammography is provided to women without signs or
symptoms of breast disease.
MRI Breast
If a benign entity has been found on US and is the definitive correlate for a palpable mass, there is no role for MRIof the breast with or without IV contrast in women <30 years of age [2,23-25].
Sestamibi MBI
If a benign entity has been found on US and is the definitive correlate for a palpable mass, there is no evidence for
Tc-99m sestamibi MBI in women <30 years of age.
Variant 10: Adult female, younger than 30 years of age. Palpable breast mass. US findings negative (BIRADS 1). Next imaging study.
Digital Breast Tomosynthesis Diagnostic
DBT is not useful unless the clinical findings are suspicious. DBT or mammography diagnostic is recommended asa prebiopsy assessment in cases in which cancer is strongly suspected clinically [41]. As with women ≥40 years of
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or surgical biopsy is warranted.
Digital Breast Tomosynthesis Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening DBT, with or without
DM, is not useful as the next imaging study. Screening mammography is provided to women without signs or
symptoms of breast disease.
FDG-PET Breast Dedicated
There is no relevant literature to support the use of the use of FDG-PET breast dedicated in women <30 years ofage with negative US findings [2].
Image-Guided Core Biopsy Breast
There is no relevant literature to support the use of the use of image-guided core biopsy in women <30 years of age
with negative US findings.
Image-Guided Fine Needle Aspiration Breast
There is no relevant literature to support the use of the use of image-guided FNAB in women <30 years of age withnegative US findings.
Mammography Diagnostic
Mammography is not useful unless the clinical findings are suspicious. Mammography is recommended as aprebiopsy assessment in cases in which cancer is strongly suspected clinically [41]. If a mammographic correlate
to a suspicious finding is identified, then stereotactic biopsy is recommended. As with women ≥40 years of age, if
physical examination is highly suspicious and mammography and US are negative, tissue sampling with core biopsy
or surgical biopsy is warranted.
Mammography Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening mammography is notuseful as the next imaging study. Screening mammography is provided to women without signs or symptoms ofbreast disease.
MRI Breast
There is no relevant literature to support the use of the use of MRI of the breast with or without IV contrast in
women in women <30 years of age with negative US findings [2,23-25].
Sestamibi MBI
There is no relevant literature to support the use of the use of Tc-99m sestamibi MBI in women <30 years of age
with negative US findings.
Variant 11: Adult female, 30 to 39 years of age. Palpable breast mass. Initial imaging.
Digital Breast Tomosynthesis Diagnostic
Diagnostic mammography, DBT, or US can be useful as initial imaging for women 30 to 39 years of age with apalpable breast mass. DBT may demonstrate subtle architectural distortion or calcifications, findings not readily
detected by US. DBT and diagnostic mammography can also provide more information regarding the extent ofdisease and the presence of additional findings in the ipsilateral breast [22]. In the absence of DBT data for women
30 to 39 years of age, the utility of DBT can be extrapolated from the diagnostic mammography data.
Mammography has been shown to add clinical value for women ≥30 years of age with a palpable breast mass.
Mammographic sensitivity is dependent on the tumor size on palpation, ranging from 78% for a palpable tumor sizeof ≤2 cm to 97% for a palpable tumor size between 2 and 5 cm [53]. DBT provided similarly accurate diagnostic
results as compared to DM in women with palpable breast masses [15]. Several small studies that specifically
included women presenting with clinical symptoms including palpable lumps demonstrated increased accuracy on
combination DM/DBT compared with DM alone [13,16,17]. In one recent study, mammography contributed to theworkup of palpable malignant masses in 16.7% of cases in women 30 to 39 years of age [54].
Digital Breast Tomosynthesis Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening DBT, with or without
DM, is not useful as the initial imaging study. Screening mammography is provided to women without signs or
symptoms of breast disease.
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FDG-PET Breast Dedicated
There is no relevant literature to support the use of the use of FDG-PET breast dedicated in the initial evaluation of
women 30 to 39 years of age with a palpable mass [2].
Image-Guided Core Biopsy Breast
There is no relevant literature to support the use of the use of image-guided core biopsy in the initial evaluation of
women 30 to 39 years of age with a palpable mass.
Image-Guided Fine Needle Aspiration Breast
There is no relevant literature to support the use of the use of image-guided FNAB in the initial evaluation of women
30 to 39 years of age with a palpable mass.
Mammography Diagnostic
Diagnostic mammography, DBT, or US can be useful as initial imaging for women 30 to 39 years of age with apalpable breast mass. Mammography has been shown to add clinical value for women ≥30 years of age with apalpable breast mass. Mammographic sensitivity is dependent on the tumor size on palpation, ranging from 78%
for a palpable tumor size of ≤2 cm to 97% for a palpable tumor size between 2 and 5 cm [53]. In one recent study,
it was demonstrated that in 16.7% of cases in women 30 to 39 years of age, mammography contributed in theworkup of malignant palpable masses [54]. For example, mammography revealed calcifications that extended
outside of the mass or associated satellite lesions. The overall contribution of diagnostic mammography for palpablebreast masses is the characterization of benign disease, evaluating the overall extent of disease and assessing theremainder of the ipsilateral breast [22].
One study of 1,208 women 30 to 39 years of age presenting with focal breast symptoms found a higher sensitivity
for US compared with mammography (95.7% versus 60.9%) but with a similar specificity (89.2% and 94.4%,
respectively), negative predictive value (99.9% and 99.2%, respectively), and positive predictive value (13.2% and18.4%, respectively) [40].
Mammography Screening
In women presenting with signs or symptoms, including a palpable breast mass, screening mammography is notuseful as the initial imaging study. Screening mammography is provided to women without signs or symptoms ofbreast disease.
MRI Breast
There is no relevant literature to support the use of MRI of the breast with or without IV contrast in the initial
evaluation of women 30 to 39 years of age with palpable mass [2,23-25].
Sestamibi MBI
There is no relevant literature to support the use of Tc-99m sestamibi MBI in the initial evaluation of women 30 to
39 years of age with palpable mass.
US Breast
Diagnostic mammography, DBT, or US can be useful as initial imaging for women 30 to 39 years of age with apalpable breast mass. Most benign lesions in young women are not visualized on mammography [41,43], and US
is therefore frequently used as the initial imaging modality in younger women. The criterion for “young” hashistorically been considered <30 years of age. However, the risk of breast cancer remains relatively low for women
30 to 39 years of age. The sensitivity of US may be higher than mammography for women <40 years of age [53].
One study of 1,208 women 30 to 39 years of age presenting with focal breast symptoms found higher sensitivity
for US compared with mammography (95.7% versus 60.9%), with similar specificity (89.2% and 94.4%,
respectively) [40]. US is a reasonable initial imaging study for women <40 years of age, with a low threshold forusing mammography if the clinical examination or other risk factors are concerning. If the mass has probably benign
US features, then short-term interval follow-up with US only may be appropriate. If a suspicious mass is identified
on US in this group, bilateral mammography is useful.
Summary of Recommendations• Variant 1: DBT diagnostic or mammography diagnostic are usually appropriate for the initial imaging of afemale patient 40 years of age or older with a palpable breast mass. These procedures can be complementary(ie, more than one procedure is ordered as a set or simultaneously in which each procedure provides uniqueclinical information to effectively manage the patient’s care).
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•

Variant 2: US breast is usually appropriate as the next imaging study for a female patient 40 years of age orolder with a palpable breast mass in which mammography findings are suspicious or highly suggestive ofmalignancy (BI-RADS 4 or 5).

•

Variant 3: Imaging is usually not appropriate as the next study for a female patient 40 years of age or older
with a palpable breast mass in which the diagnostic mammography, DBT, and US findings are probably benign(BI-RADS 3).

•

Variant 4: US breast maybe appropriate as the next imaging study for a female patient 40 years of age or older
with a palpable breast mass in which mammography findings are benign (BI-RADS 2) at the site of palpable
mass.

•

Variant 5: US breast is usually appropriate as the next imaging study of a female patient 40 years of age orolder with a palpable breast mass in which mammography findings are negative (BI-RADS 1).

•

Variant 6: US breast is usually appropriate as the initial imaging of a female patient younger than 30 years ofage with a palpable breast mass.

•

Variant 7: DBT diagnostic, mammography diagnostic, or image-guided core biopsy breast are usually
appropriate as the next imaging study of a female patient younger than 30 years of age with a palpable breast
mass in which US findings are suspicious or highly suggestive of malignancy (BI-RADS 4 or 5). These
procedures can be complementary (ie, more than one procedure is ordered as a set or simultaneously in which
each procedure provides unique clinical information to effectively manage the patient’s care). The panel did
not agree on recommending image-guided fine needle aspiration breast for this clinical scenario. There isinsufficient medical literature to conclude whether or not these patients would benefit from this procedure. This
procedure in this patient population is controversial but may be appropriate.

•

Variant 8: Imaging is usually not appropriate as the next study in a female patient younger than 30 years ofage with a palpable breast mass in which US findings are probably benign (BI-RADS 3).

•

Variant 9: Imaging is usually not appropriate as the next study in a female patient younger than 30 years ofage with a palpable breast mass in which US findings are benign (BI-RADS 2).

•

Variant 10: Imaging is usually not appropriate as the next study in a female patient younger than 30 years ofage with a palpable breast mass in which US findings are negative (BI-RADS 1).

•

Variant 11: US breast, DBT diagnostic, or mammography diagnostic are usually appropriate as the initial
imaging of a female patient 30 to 39 years of age with palpable breast mass. These procedures can becomplementary (ie, more than one procedure is ordered as a set or simultaneously in which each procedureprovides unique clinical information to effectively manage the patient’s care).

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 towww.acr.org/ac.

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Appropriateness Category Names and Definitions
Appropriateness Category Name
Usually Appropriate

May Be Appropriate

May Be Appropriate(Disagreement)

Usually Not Appropriate

AppropriatenessRatingAppropriateness Category Definition

7, 8, or 9

The imaging procedure or treatment is indicated in thespecified clinical scenarios at a favorable risk-benefit
ratio for patients.

4, 5, or 6

The imaging procedure or treatment may be indicatedin the specified clinical scenarios as an alternative toimaging procedures or treatments with a morefavorable risk-benefit ratio, or the risk-benefit ratio forpatients is equivocal.

5

The individual ratings are too dispersed from the panel
median. The different label provides transparency
regarding the panel’s recommendation. “May beappropriate” is the rating category and a rating of 5 is
assigned.

1, 2, or 3

The imaging procedure or treatment is unlikely to be
indicated in the specified clinical scenarios, or therisk-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 whenselecting the appropriate imaging procedure. Because there is a wide range of radiation exposures associated withdifferent 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 atinherently higher risk from exposure, because of both organ sensitivity and longer life expectancy (relevant to thelong latency that appears to accompany radiation exposure). For these reasons, the RRL dose estimate ranges forpediatric 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 [55].
Relative Radiation Level Designations
Adult Effective Dose Estimate
Range

Pediatric Effective Dose Estimate
Range

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

Relative Radiation Level*
O

☢

☢☢☢

☢☢☢☢☢

*RRL assignments for some of the examinations cannot be made, because the actual patient doses in these procedures varyas 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.”

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The ACR Committee on Appropriateness Criteria and its expert panels have developed criteria for determining appropriate imaging examinations fordiagnosis and treatment of specified medical condition(s). These criteria are intended to guide radiologists, radiation oncologists and referring physicians inmaking decisions regarding radiologic imaging and treatment. Generally, the complexity and severity of a patient’s clinical condition should dictate theselection 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 andradiologist in light of all the circumstances presented in an individual examination.

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