ACR Appropriateness Criteria on Nonpalpable Mammographic

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ACR Appropriateness Criteria® onNonpalpable Mammographic Findings

(Excluding Calcifications)Mary S. Newell, MDa, Robyn L. Birdwell, MDb, Carl J. D’Orsi, MDc,

Lawrence W. Bassett, MDd, Mary C. Mahoney, MDe, Lisa Bailey, MDf,g,Wendie A. Berg, MD, PhDh, Jennifer A. Harvey, MDi, Cheryl R. Herman, MDj,

Stuart S. Kaplan, MDk, Laura Liberman, MDl, Ellen B. Mendelson, MDm,Jay R. Parikh, MDn, Rachel Rabinovitch, MDo, Eric L. Rosen, MDp,

M. Linda Sutherland, MDq

Screening mammography can detect breast cancer before it becomes clinically apparent. However, the screeningprocess identifies many false-positive findings for each cancer eventually confirmed. Additional tools are available tohelp differentiate spurious findings from real ones and to help determine when tissue sampling is required, whenshort-term follow-up will suffice, or whether the finding can be dismissed as benign. These tools include additionaldiagnostic mammographic views, breast ultrasound, breast MRI, and, when histologic evaluation is required,percutaneous biopsy. The imaging evaluation of a finding detected at screening mammography proceeds mostefficiently, cost-effectively, and with minimization of radiation dose when approached in an evidence-based manner.The appropriateness of the above-referenced tools is presented here as they apply to a variety of findings oftenencountered on screening mammography; an algorithmic approach to workup of these potential scenarios is alsoincluded. The recommendations put forth represent a compilation of evidence-based data and expert opinion of theACR Appropriateness Criteria® Expert Panel on Breast Imaging.

Key Words: Appropriateness Criteria®, breast imaging, mammography, breast ultrasound, breast MRI,percutaneous breast biopsy

J Am Coll Radiol 2010;7:920-930. Copyright © 2010 American College of Radiology

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UMMARY OF LITERATURE REVIEW

ith improved imaging techniques, screening mam-ography enables the early detection of smaller cancers.ost lesions detected mammographically are benign.oncalcified lesions of concern on screening mammog-

Emory University, Atlanta, Georgia.

Brigham and Women’s Hospital, Harvard Medical School, Boston, Massa-husetts.

Emory University Hospital, Atlanta, Georgia.

University of California, Los Angeles, School of Medicine, Los Angeles,alifornia.

University of Cincinnati, Cincinnati, Ohio.

Alta Bates Summit Medical Center, Oakland, California.

American College of Surgeons, Chicago, Illinois.

Johns Hopkins at Green Spring, Lutherville, Maryland.

University of Virginia Medical Center, Charlottesville, Virginia.

Mallinckrodt Institute of Radiology, St Louis, Missouri.

Mount Sinai Medical Center, Miami Beach, Florida.

Memorial Sloan-Kettering Cancer Center, New York, New York. m

20

aphy include masses, bilateral masses, focal asymme-ries, and architectural distortion. Benchmark data basedn information from the Breast Cancer Surveillanceonsortium report a positive predictive value in 33% ofiopsies performed [1]. The mean cancer detection rateeported for screening mammography is 4.7/1,000

Northwestern University, Chicago, Illinois.

Swedish Medical Center, Seattle, Washington.

University of Colorado Cancer Center, Denver, Colorado.

Seattle Cancer Care Alliance, Seattle, Washington.

Newport Diagnostic Center, Newport Beach, California.

Corresponding author and reprints: Mary S. Newell, MD, American Col-ege of Radiology, 1891 Preston White Drive, Reston, VA 20191; e-mail:

[email protected].

The ACR seeks and encourages collaboration with other organizations onhe development of the ACR Appropriateness Criteria® through society rep-esentation on expert panels. Participation by representatives from collaborat-ng societies on the expert panel does not necessarily imply society endorse-

ent of the final document.

© 2010 American College of Radiology0091-2182/10/$36.00 ● DOI 10.1016/j.jacr.2010.07.006

mailto:[email protected]

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Newell et al/Nonpalpable Mammographic Findings 921

ammograms, with a mean invasive cancer size of 13m [2,3].Normal soft-tissue densities can simulate a mass, and

dditional mammographic or ultrasound evaluation maye necessary to determine the presence of a true mass.asses are 3-D structures with convex outward con-

ours. Asymmetric breast tissue is planar, often with con-ave outward contours and if new or enlarging on screen-ng mammography should be further evaluated withiagnostic imaging. Similarly, when a new or enlargingass is suspected, additional imaging is necessary, using

dditional views and possibly ultrasound [4-6]. When aass is detected mammographically, assessment of its

hape, margin, density, and size should be performed asutlined in the ACR Breast Imaging Reporting and Dataystem® (BI-RADS®) atlas [7-12] (see Variants 1-8).

Variant 1. Architectural distortion seen on screenintrauma; next examination to perform

Radiologic Procedure RaMammography diagnostic

Mammography short-interval follow-up

Ultrasound breast

MRI breast without and with contrast

Core biopsy breast

Note: Rating scale: 1, 2, and 3 � usually not appropriate; 4, 5, aAppendix A for additional steps in the workup of these patients.

Variant 2. Architectural distortion seen on screenindistortion; no prior examinations available; next exa

Radiologic Procedure RatingMammography diagnostic 6 Use of a

screenfor dia

Return to screeningmammography

4 If the areto be rscar m(eg, prreturn

Mammography short-intervalfollow-up

1

Ultrasound breast 1

MRI breast without and withcontrast

1

Core biopsy breast 1

Note: Rating scale: 1, 2, and 3 � usually not appropriate; 4, 5, a
Appendix A for additional steps in the workup of these patients.
Ultrasound has the ability to determine the cystic orolid nature of a breast mass and may be helpful in di-ecting biopsy of architectural distortion and suspiciousocal asymmetries. Adhering to strict criteria, this tech-ique can separate cystic from solid masses with an accu-acy approaching 100% [9]. Using good-quality, high-requency equipment, cysts as small as 2 to 3 mm iniameter can be demonstrated. However, cysts that are8 mm or deeper than 3 cm from the skin can be

ifficult to characterize as anechoic [13,14]. After finalammographic evaluation, round or oval masses with

ircumscribed, partially obscured, indistinct, or mi-rolobulated margins can be further investigated withltrasound to characterize simple cysts, complicatedysts, complex cystic and solid masses (a complex massmplies both cystic and solid components), and solid

ammography; no history of prior surgery or

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Radiation Level

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6 � may be appropriate; 7, 8, and 9 � usually appropriate. See

ammography; prior surgery or trauma area ofnation to perform

CommentsRelative

Radiation Levelar marker on the originalstudy may preclude the need

ostic evaluation.can be confidently determinedted to prior surgery (ie, byer) or the sequelae of traumance of fat necrosis), consider

screening mammography.

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922 Journal of the American College of Radiology/Vol. 7 No. 12 December 2010

asses [15]. Masses with mammographic findings thatre suspicious or highly suggestive of malignancy, orasses with suspicious or typically benign calcifications,

o not require ultrasound for assessment, although it cane used to guide needle biopsy if the mass is seen sono-raphically [15].

The use of MRI to evaluate nonpalpable mammo-raphically occult, suspicious noncalcified lesions is be-ng addressed. Although efficacy as to the reduction ofumbers of deaths from breast cancer has not been dem-nstrated, some of the current uses of MRI include thevaluation of the extent of recently diagnosed breast can-er within the ipsilateral breast [16-18], the assessment ofhe contralateral breast for clinically and mammographi-ally occult synchronous breast cancer, and the detectionf primary occult breast cancer in cases presenting asxillary adenopathy [19,20]. A multi-institutional trialeported in 2007 discovered clinically and mammo-raphically occult breast cancer in 3% of the 969 womenho had recent diagnoses of breast cancer in the oppositereast [21]. In part because of the relatively low specific-ty of breast MRI, screening for breast cancer has only

Variant 4. Mass seen on screening mammographyup); circumscribed margins with no associated suspexaminations or no prior examinations available; ne

Radiologic Procedure RatingUltrasound breast 9Mammography diagnostic 5 In

vee

Mammography short-interval follow-up 1

MRI breast without and with contrast 1



Variant 3. Mass seen on screening mammographyup); indistinct, microlobulated or spiculated margins



Ultrasound breast


Core biopsy breast

Note: Rating scale: 1, 2, and 3 � usually not appropriate; 4, 5, aAppendix B for additional steps in the workup of these patients.

Appendix B for additional steps in the workup of these patients.

ecently been recommended by the American Cancerociety (ACS) [22] and, on the basis of peer-reviewediterature [23,24] or expert consensus, only for thoseomen with known or suspected gene mutations increas-

ng their susceptibility to develop breast cancer, for thoseomen with at least a 20% to 25% lifetime risk assess-ent, and for those women who have been treated with

hest or mediastinal radiation for Hodgkin’s lymphoma8 years earlier and before the age of 30 years. At this

ime, the ACS finds no compelling data to support orefute the performance of breast MRI for those womenaving only personal histories of breast cancer, historiesf biopsy-proven lobular neoplasia or atypical ductal hy-erplasia, or dense breast tissue. Finally, the ACS recom-ends against the performance of screening MRI for

hose women with a �15% lifetime risk.After appropriate workup of a mammographically de-

ected noncalcified suspicious lesion, which will usuallynclude diagnostic mammography and ultrasound, a fi-al assessment should be assigned according to the BI-ADS guidelines [7]. Articles have validated the ap-roach of following probably benign lesions (category 3),

suming mass has not previously been workedious features; new or enlarging compared with priorexamination to perform

CommentsRelative

Radiation LevelO

lected cases, spot/magnificationws may help elucidate margins,lude intramammary node aslogy.

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Not specified


suming mass has not previously been workedext examination to perform

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s outlined in the BI-RADS atlas, to decrease the numberf biopsies of benign lesions and potentially substantiallyeduce cost [25-27]. If a noncalcified lesion is placed inategory 4 or 5, a biopsy is warranted. This biopsy is mostften performed as a sampling or incisional proceduresing stereotactic or ultrasound guidance to obtain a coref tissue or cellular aspirate via the fine-needle technique.owever, a core biopsy or needle aspirate should be doneith the goal of either shortening the diagnostic processr providing a more cost-effective method of lesion diag-osis compared with excisional biopsy [28,29]. For ex-mple, if a solid mass is diagnosed as fibroadenoma onore biopsy and then undergoes surgical excision for anyf a variety of reasons, cost has been added and theiagnostic procedure lengthened with no gain. On thether hand, a core biopsy may be used to provide histol-gy for a category 5 lesion so that excision and sentinelode biopsy can be done simultaneously, avoiding sepa-ate trips to the operating room.

There are advantages and disadvantages to core needleiopsy and fine-needle aspiration biopsy (FNAB) tech-iques [30,31]. The FNAB technique requires a trainedytopathologist. The report of a multicenter, random-

Variant 6. Multiple bilateral masses seen on screenor a dominant mass is present; next examination to

Radiologic Procedure RatingMammography diagnostic 9

Ultrasound breast 5 M





Variant 5. Multiple bilateral masses seen on screenmass; baseline examination or no prior examination

Radiologic Procedure RatingReturn to screening mammography 8


Ultrasound breast 1



Note: Rating scale: 1, 2, and 3 � usually not appropriate; 4, 5, aAppendix C for additional steps in the workup of these patients.

Appendix C for additional steps in the workup of these patients.

zed trial [32-34] demonstrated a 10% insufficiency rateor ultrasound-guided FNAB and up to a 39% insuffi-iency rate for stereotactically guided FNAB. The overallccuracy for ultrasound-guided FNAB was 77%, whereasor stereotactically guided FNAB, accuracy was only8%. Percutaneous core biopsy provides tissue samplesllowing accurate distinction between in situ and inva-ive carcinoma. Stereotactic core biopsies may be per-ormed with the patient sitting or on specialized proneables, and the most commonly sampled lesion type isalcifications. Issues of potential sampling error must beddressed with careful evaluation of imaging-histologiconcordance. Technical success is reported in as many as8% of cases [35], and an average of �10 samples using1-gauge vacuum-assisted needles improves accuracynd decreases (but does not eliminate) possible upgradesrom atypical ductal hyperplasia to cancer or ductal car-inoma in situ to invasive carcinoma [36-38]. Ultra-ound-guided core biopsy, typically used to sampleasses, may be successfully performed using either auto-ated 14-gauge needles or vacuum-assisted devices and

hould include �4 nonfragmented samples [39-41].imilar to any percutaneous biopsy sampling, the final

mammography; one or more masses suspiciousrform

CommentsRelative

Radiation Level

proceed directly to ultrasoundmass in question is seen ino projections.

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mammography; no suspicious features in anyvailable; next examination to perform.

CommentsRelative

Radiation Level

In selected cases, maybe appropriate. O

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ssessment as to follow-up recommendations must in-lude strict vigilance regarding imaging and pathologyorrelation.

UMMARY

creening mammography potentiates the detection ofarly, clinically occult cancers, with benchmark dataemonstrating the mean size at diagnosis to be 13 mmnd cancers detected at a rate of 4.7/1,000 screeningxaminations. Most lesions found on screening mam-ography, however, are benign, with positive predictive

alue of 33% for lesions undergoing biopsy.Additional workup, including diagnostic mammogra-

hy or ultrasound, may be required to differentiate sus-icious findings, such as masses and asymmetries or focalsymmetries, from normal breast tissue. Application ofhe ACR BI-RADS criteria, terminology, and assess-ents helps guide management and optimizes commu-

ication of findings and recommendations.Ultrasound is a useful adjunctive tool in the evaluation

f abnormal mammographic findings but requires these of good-quality, high-frequency equipment and ap-

Variant 7. Focal asymmetry or asymmetry (single-vprior examinations available; next examination to pe



Return to screening mammography

Ultrasound breast


Core biopsy breast

Note: Rating scale: 1, 2, and 3 � usually not appropriate; 4, 5, aAppendix D for additional steps in the workup of these patients.

Variant 8. Focal asymmetry or asymmetry (single-vor enlarging from prior examination; next examinatio



Return to screening mammography

Ultrasound breast


Core biopsy breast

Appendix D for additional steps in the workup of these patients.
lication of strict criteria, outlined in the BI-RADS atlas.reast ultrasound can help differentiate cysts from solidasses, aid in the characterization of solid masses, and

uide percutaneous biopsy.Breast MRI is a technology whose roles and indica-

ions are still evolving. Its effectiveness in outlining ex-ent of disease and detecting occult contralateral cancersn newly diagnosed breast cancer patients has been dem-nstrated; however, mortality reduction has not beenonfirmed. The ACS has recommended its use as acreening tool in select populations, on the basis of evi-ence and expert consensus. The ACS recommendsgainst MRI screening in women with a �15% esti-ated lifetime risk.Percutaneous biopsy of suspicious lesions can provide

ccurate tissue diagnosis at decreased cost, precluding theeed for surgery in benign, specific cases and allowingefinitive single-stage surgical treatment in cases re-urned as malignant. Core needle biopsy, using eithertereotactic or ultrasound guidance, is preferable to fine-eedle aspiration cytology, on the basis of sufficiency andccuracy of sampling.

finding) seen on screening mammography; norm

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Radiation Level

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finding) seen on screening mammography; newto perform

g CommentsRelative

Radiation Level

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ELATIVE RADIATION LEVEL INFORMATION

otential adverse health effects associated with radiationxposure are an important factor to consider when select-ng the appropriate imaging procedure. Because there is aide range of radiation exposures associated with differ-

nt diagnostic procedures, a relative radiation level indi-ation has been included for each imaging examination.he relative radiation levels are based on effective dose,hich is a radiation dose quantity that is used to estimateopulation total radiation risk associated with an imag-ng procedure. Patients in the pediatric age group are atnherently higher risk from exposure, both because ofrgan sensitivity and longer life expectancy (relevant tohe long latency that appears to accompany radiationxposure). For these reasons, the relative radiation levelose estimate ranges for pediatric examinations are lowerompared with those specified for adults (Table 9). Ad-itional information regarding radiation dose assessmentor imaging examinations can be found in ACR Appro-riateness Criteria®: Radiation Dose Assessment Introduc-ion [42].

Disclaimer: The ACR Committee on Appropriatenessriteria® and its expert panels have developed criteria foretermining appropriate imaging examinations for the di-gnosis and treatment of specified medical conditions. Theseriteria are intended to guide radiologists, radiation oncolo-ists, and referring physicians in making decisions regardingadiologic imaging and treatment. Generally, the complex-ty and severity of a patient’s clinical condition should dic-ate the selection of appropriate imaging procedures or treat-ents. Only those examinations generally used for the

valuation of a patient’s condition are ranked. Other imag-ng studies necessary to evaluate other coexistent diseases orther medical consequences of this condition are not consid-red in this document. The availability of equipment orersonnel may influence the selection of appropriate imagingrocedures or treatments. Imaging techniques classified asnvestigational by the US Food and Drug Administration

Table 9. Relative radiation level designations

Relative Radiation LevelAdult Effe

Estimate RO

�0.1

11030

Note: Relative radiation level assignments for some of the examiprocedures vary as a function of a number of factors (eg, region ois used). The relative radiation levels for these examinations are

ave not been considered in developing these criteria, but the

tudy of new equipment and applications should be encour-ged. The ultimate decision regarding the appropriateness ofny specific radiologic examination or treatment must beade by the referring physician and radiologist in light of all

he circumstances presented in an individual examination.

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http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/RRLInformation.aspx




APPENDIX A


APPENDIX B


APPENDIX C


APPENDIX D

Documents

ACR Appropriateness Criteria on Nonpalpable Mammographic