Imaging Management of Palpable Breast Abnormalities

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1 Women s Imaging Best Practices/Review Lehman et al. Imaging of Breast Abnormalities Women s Imaging Best Practices/Review Constance D. Lehman 1 Amie Y. Lee Christoph I. Lee Lehman CD, Lee AY, Lee CI Keywords: breast, evidence-based medicine, mammography, ultrasound DOI: /AJR Received February 18, 2014; accepted after revision April 7, C. D. Lehman has received honoraria from GE Healthcare and Bayer HealthCare, serving as an advisory board member and scientific expert. C. I. Lee has received consulting fees from GE Healthcare and is currently supported in part by a grant cosponsored by GE Healthcare and the Association of University Radiologists. 1 All authors: Department of Radiology, University of Washington, Seattle Cancer Care Alliance, 825 Eastlake Ave E, G3-200, Seattle, WA Address correspondence to C. D. Lehman (lehman@uw.edu). This article is available for credit. AJR 2014; 203: X/14/ American Roentgen Ray Society Imaging Management of Palpable Breast Abnormalities OBJECTIVE. Women commonly present to imaging departments with a palpable breast abnormality. However, widespread confusion remains regarding the most appropriate sequence and extent of imaging required. The purpose of this article is to discuss the evidence informing current management guidelines for the care of patients with palpable breast abnormalities. CONCLUSION. Ultrasound is a highly effective imaging tool for guiding effective evaluation of women with palpable breast abnormalities and should be used for all women with suspicious findings at clinical breast examination. The exception is cases in which mammography shows a clearly benign correlate or a normal, fatty area of breast tissue in the location of the palpable finding. Breast ultrasound should be the primary imaging tool for women with palpable lumps who are pregnant, lactating, or younger than 30 years. For women 40 years old and older, mammography, followed in most cases by ultrasound, is recommended. For women years old, ultrasound or mammography may be performed first at the discretion of the radiologist or referring provider. There is little to no role for breast MRI or other advanced imaging technologies in the routine diagnostic evaluation of palpable breast abnormalities. Vignettes and Images A palpable breast mass, either self-detected or found at clinical breast examination, is a common presenting symptom in women. Although most lumps ultimately are found to be benign, a palpable lump can cause understandable anxiety for the patient and lead to repeated clinical and imaging evaluation, biopsy, and surgery. Given that a palpable breast mass is the most common symptom associated with breast cancer [1], patient concern is understandable, and prompt and appropriate diagnostic workup is warranted. Most women with a clinically suspicious palpable lump need an imaging evaluation. Yet there is still general confusion about specific types and sequencing of imaging studies in this setting. For instance, a common indication for diagnostic breast MRI in U.S. community practices is problem solving in regard to a clinical finding [2]. However, to our knowledge, there is no evidence to support the utility of breast MRI for patients with palpable masses and no evidence that breast MRI leads to clinical benefit for such patients. Ultrasound and mammography, when used appropriately, are effective and safe for triage of most women to clinical follow-up, a small portion to imaging follow-up, and the minority to image-guided core needle biopsy [3 5]. These primary imaging modalities and minimally invasive needle biopsy techniques play a central role in reducing costs and morbidity associated with unnecessary advanced imaging (e.g., MRI) and surgery in this specific patient population. The radiologist in collaboration with the patient and referring provider plays a critical role in supporting the appropriate evaluation and care of women with palpable breast abnormalities. We present clinical vignettes in Figures 1 6. These scenarios serve as examples of the care of women presenting to our breast imaging clinic with palpable breast masses. The Imaging Question What is the appropriate management when a woman presents to an imaging department with a palpable breast abnormality? Background and Importance Historically, the primary care physician and breast surgeon were responsible for the diagnostic evaluation of palpable breast 1142 AJR:203, November 2014

2 Imaging of Breast Abnormalities masses, and imaging played a minor role. Fine-needle aspiration biopsy, often without imaging evaluation, was commonly used as a first step for differentiating cystic from solid lesions [6]. Persistent solid masses would nearly always be subjected to open excisional biopsy for definitive diagnosis [7, 8]. Starting in the mid-1990s, advances in imaging technology dramatically changed the evaluation of women with palpable breast lumps. Ultrasound technology applied to breast imaging improved markedly with the development of high-megahertz linear array transducers with better near-field resolution, compound imaging, and harmonics, all of which led to improved characterization of the shape, margins, and internal echotexture of masses [9]. In 1998, the U.S. Department of Health and Human Services provided funding through the Office on Women s Health to support research in breast ultrasound, and the American College of Radiology (ACR) further supported these efforts through the development of a structured approach to characterization of breast lesions identified with ultrasound. This led to the publication in 2003 of the first BI-RADS lexicon for breast ultrasound [10]. Also during this time, improved methods of image-guided minimally invasive needle biopsy were developed. These techniques enabled less costly, less morbid, and highly accurate methods of tissue diagnosis of suspicious lesions presenting as palpable breast lumps. research since the mid-1990s has supported the development of evidence-based approaches to best practice recommendations for women with palpable breast lumps. The practice paradigm changed from one in which most women with palpable lumps underwent needle aspiration or surgical intervention to one in which only a small minority of women need either. This paradigm shift has resulted in the radiologist s becoming an essential and central figure in the appropriate care of women with palpable masses, because most of the workup and diagnosis of a palpable breast lump is routinely completed within the imaging department. Given this change in the radiologist s role, it is critical to ensure that best practices are followed with strict adherence to evidence-based imaging guidelines. Figures 7 and 8 summarize our institution s diagnostic algorithms, which are consistent with the 2012 ACR appropriateness criteria for management of palpable breast masses [11]. A new, palpable mass remains the most common presenting sign or symptom of breast cancer [12, 13]. Furthermore, palpation-detected breast malignancies are more aggressive than nonpalpable cancers detected with screening mammography. Palpable presentation is associated with higher tumor grade, higher rates of lymph node positivity, higher rates of triplenegative phenotype, and greater risk of local and distant tumor recurrence [12 15]. Therefore, every effort should be made to avoid delays in diagnosis of a palpable breast cancer. That said, most palpable breast masses are eventually determined to be benign. The goal of the imaging workup of palpable breast lumps is to diagnose malignant lesions while avoiding unnecessary interventions for benign lesions. Synopsis and Synthesis of Evidence We reviewed all articles found regarding the imaging management of palpable breast masses published between January 1990 and January References were identified through a citation search of the English-language literature on PubMed using the following search terms: (palpable AND breast) AND (mass OR lump) AND (mammography OR ultrasound OR radiology OR imaging). Publications relevant to the evaluation and management of palpable breast masses were selected. We also manually searched the references of selected original articles, review articles, and meta-analyses to identify additional pertinent studies that may have been missed in the primary search. From this literature search, 48 articles were selected for detailed review and inclusion in this article. Twenty-four were from radiology journals, six from surgical journals, six from internal and family medicine journals, seven from breast or women s health journals, three from oncology and cancer journals, and two from general medical journals. We included 34 retrospective studies, four prospective studies, one meta-analysis, one phantom study, and eight review articles and guidelines. Of the references that covered specific diagnostic imaging modalities, 11 focused primarily on ultrasound, five on mammography, 14 on both mammography and ultrasound, and four on MRI. Articles on the evaluation of breast symptoms other than palpable abnormalities, such as nipple discharge and skin changes in the absence of a palpable mass, were considered beyond the scope of our report and were therefore excluded. Evidence-Based Guidelines History The clinical history should include assessment of symptoms, including time at onset as noted by either the patient or the referring health care provider; fluctuations over time; association with menstrual cycle; and recent trauma, nipple discharge, pain, fever, and erythema. Risk assessment includes family and personal history of breast cancer and known genetic mutations, pathologic report of previous breast biopsies, and history of radiation exposure at a young age. Such history can be helpful in establishing the initial level of suspicion of malignancy [16]. Physical Examination A clinical breast examination should be performed for all women presenting with a breast lump. Most often, the patient s referring provider or breast specialist has performed a thorough examination of both breasts. However, the breast imager should be familiar with the performance of the breast examination and ideally should perform a focused examination targeted at the area of concern to assess concordance between the imaging findings and the clinical examination findings [17]. At physical examination a dominant mass should feel different from surrounding breast parenchyma and should feel asymmetric compared with the contralateral breast. Masses suggestive of malignancy are more likely to be firm, immobile, and fixed to the surrounding breast tissue or skin (as evidenced by skin dimpling or nipple retraction) and to have indistinct margins [7]. Benign masses are more likely to be mobile and have smooth, well-defined margins. Normal structures that can be mistaken for a breast mass include a prominent rib, costochondral junction, prominent fat lobule, or discrete ridge of normal fibroglandular tissue. The focused clinical examination allows the imager to ensure that the correct site is being evaluated at targeted ultrasound. It also allows assessment of concordance between the imaging and physical examination findings. Determining concordance should include comparison of location, size, shape, and margin of the palpable lesion with any potential corresponding lesion identified at imaging. If the lesion cannot be felt at imaging, then the previous description by the patient or referring provider should be used to direct the imaging and concordance evaluation. Mammography Mammography is recommended as the first imaging modality in the evaluation of palpable breast findings in women 40 years AJR:203, November

3 Lehman et al. old and older. A radiopaque marker should be placed over the site of clinical concern. If the patient has undergone recent ( 6 months) bilateral mammography, only ipsilateral mammography is indicated. In addition to craniocaudal and mediolateral oblique whole-breast mammographic views of the affected breast, spot compression and magnification views are typically obtained of the area of clinical concern. If mammography reveals a clearly benign cause of the palpable abnormality, such as a calcified involuting fibroadenoma, lymph node, lipoma, hamartoma, galactocele, or oil cyst, or if only fatty tissue is present in the area of concern, no further imaging is needed. For all other mammographic findings, including masses with probably benign or suspicious features, further evaluation with targeted ultrasound is indicated. Normal mammographic findings are not sufficient to rule out malignancy in a nonfatty breast. If there is no mammographic finding at the site of the palpable lump, further workup with targeted ultrasound is required. Approximately 13% of women with palpable breast cancer have normal mammographic findings [18]. False reassurance from a normal mammogram can lead to a delay in cancer diagnosis. One study [19] showed that among women with a palpable breast mass and normal mammographic findings, only 57% of women received adequate complete evaluation. In another study [20], in which the participants were women with self-detected palpable breast lumps, 32% of women with cancer and normal mammographic findings had delayed diagnoses. Ultrasound Historically, use of breast ultrasound was limited to differentiating cysts from solid masses [21]. It was otherwise thought that ultrasound had little or no place in the evaluation of palpable breast masses [7]. With technologic advances, ultrasound has become an essential part of managing palpable breast masses [3, 4, 22 24]. It is the primary imaging modality for women younger than 40 years presenting with a palpable breast mass and is a critical adjunct to mammography for older patients. A woman with a palpable lump corresponding to a clearly benign finding at targeted ultrasound, such as simple cyst, nonpathologic lymph node, lipoma, sebaceous cyst, clustered microcysts, or duct ectasia, can safely undergo clinical follow-up without short-interval imaging follow-up, needle aspiration, or biopsy. The addition of ultrasound to the evaluation of palpable breast lumps improves cancer detection. One study [22] showed that 11% of palpable breast cancers were visible at ultrasound but were mammographically occult. Similarly, use of targeted ultrasound was found to increase cancer detection by 14% in patients with symptoms who were evaluated with both mammography and ultrasound [23]. When both mammographic and ultrasound findings are negative in the evaluation of a palpable breast mass, the negative predictive value is high, ranging from 97% to 100% [3, 4, 23 26]. Reported values in the literature are summarized in Table 1. If combined imaging findings are negative and clinical breast examination findings are not highly suspicious, the patient may be reassured of the negative findings and safely undergo clinical follow-up with her health care provider. However, any highly suspicious mass found at clinical examination should be biopsied, regardless of negative imaging findings, because of the extremely small but present risk of malignancy. Palpable masses may have probably benign features at targeted ultrasound (solid mass with circumscribed margins, oval shape, and horizontal orientation). Previously, the use of BI-RADS category 3 assessment with a short-term follow-up recommendation was reserved only for nonpalpable findings, as reflected in the th edition ACR BI-RADS manual specifications [10]. More recent evidence, however, has shown that short-term follow-up imaging is an acceptable alternative to immediate biopsy in the management of palpable lesions with probably benign ultrasound features. Rates of malignancy of palpable probably benign lesions are not significantly different from those of nonpalpable probably benign lesions [27, 28]. The current th edition ACR BI-RADS [29] supports the application of probably benign assessments for palpable as well as nonpalpable breast masses. Table 2 shows the rates of malignancy of palpable solid masses with probably benign ultrasound features, which range from 0 to 0.9% [28, 30 33]. Although Shin et al. [27] reported a rate of malignancy of 3.2%, they studied a distinct subgroup of patients with probably benign lesions who proceeded to needle biopsy. Thus those authors attributed the higher cancer rate to including in their population only masses subjected to core needle biopsy rather than all probably benign masses. For this reason, the study is excluded from Table 2. At our institution, palpable masses with probably benign ultrasound features are assessed as BI-RADS category 3. Patients are reassured of the very low risk of breast cancer and undergo follow-up by ultrasound for 2 years at 6-month intervals. Some patients prefer to undergo immediate core needle biopsy rather than follow-up, which may be a reasonable alternative for a subset of patients. In these cases, TABLE 1: Negative Predictive Value of Normal Mammogram and Normal Ultrasound Findings (No Visible Finding) in the Setting of a Palpable Breast Abnormality Reference Year No. of Palpable a Lesions With Negative b Combined Imaging Findings No. of False-negative Findings No. of True-negative Findings Negative Predictive Value (%) Mean Age (y) Range Dennis et al. [3] Gumus et al. [25] Lehman et al. [5] Moss et al. [23] Moy et al. [24] Shetty et al. [26] Soo et al. [4] Note Dash ( ) indicates data were not reported and could not be deduced from available data. a Two studies included breast symptoms, not restricted to palpable findings. In the study by Lehman et al. [5], 87% of the entire symptomatic study cohort (1050/1208) had palpable symptoms. In the study by Moss et al. [23], 85% (474/559) had palpable symptoms. b No visible finding at ultrasound of mammography (BI-RADS category 1) AJR:203, November 2014

4 image-guided core needle biopsy is encouraged over surgical excision because of the lower costs, lower morbidity, and high diagnostic accuracy of ultrasound-guided needle biopsy compared with surgical excision. Imaging of Breast Abnormalities TABLE 2: Rate of Malignancy of Palpable Breast Abnormalities With Probably Benign Ultrasound Features Reference Year Age (y) No. of Cancer Detection Rate Mean Range Symptomatic Lesions a No. of Cancers % 95% CI Giess et al. [30] Graf et al. [31] b Harvey et al. [28] Lehman et al. [5] Loving et al. [37] Park et al. [32] Smith et al. [33] 2008 < 25 c Note Dash ( ) indicates data were not reported and could not be deduced from available data. a Symptomatic lesions with probably benign ultrasound features. All studies included only palpable lesions, except two studies (Lehman et al. [5] and Loving et al. [37]), which included focal breast signs or symptoms. b One-sided 95% CI. c Inclusion criteria. Range not provided. MRI Despite the lack of supporting evidence, MRI is still used as a problem-solving tool for evaluation of breast symptoms. One study [34] showed that 5% (276/5769) of MRI examinations in U.S. community health care settings were performed for the indication of persistent clinical breast concern with negative imaging. At our institution, in a study of MRI examinations between 2003 and 2007 [35], we found that 7% (204/3001) of MRI examinations were performed for the indication of problem solving and that a palpable lesion or other clinical finding was the most common problem-solving indication, accounting for 55%. Both of these studies concluded that breast MRI is not an appropriate imaging technique for evaluation of palpable symptoms, because it provides little added information to careful evaluation with mammography and ultrasound. In the cases in our study in which MRI was accurate for identifying malignancy in the area of clinical concern, biopsy would likely have been performed regardless of the MRI findings either because of level of clinical concern or because of suspicious mammographic or ultrasound findings. MRI also resulted in additional, unnecessary biopsies due to falsepositive findings in areas distinct from the site of initial clinical concern. Furthermore, negative MRI findings can cause false reassurance and poor compliance with subsequent follow-up recommendations based on mammographic or ultrasound results [34]. Fortunately, at our institution and others, the use of breast MRI for problem solving regarding clinical breast concerns has continued to steadily decrease each year since these studies were conducted. It now represents less than 0.5% of all breast MRI examinations performed at our institution annually. One clinical scenario in which MRI may be helpful is questioned physical examination changes at the site of a lumpectomy, for which neither mammographic nor ultrasound findings are definitive. MRI can be helpful for differentiating scar from recurrence in the specific setting of suspicious clinical examination findings with inconclusive mammographic or ultrasound findings [36]. Scenarios Women Age 40 and Older Our recommended management algorithm for women 40 years old and older presenting with a palpable breast abnormality is summarized in Figure 7. For women in this age group, diagnostic mammography is the first step in the imaging evaluation. If more than 6 months have passed since the patient s last screening mammogram, both breasts should be imaged to screen for additional clinically occult malignancy. Otherwise, the examination should be focused on the symptomatic breast, as detailed earlier (see Evidence-Based Guidelines). Briefly, if a clearly benign cause of the palpable symptom is confirmed at mammography, no further imaging is needed. In essentially all other cases, a targeted ultrasound examination should follow the mammographic examination [11]. In the case of a suspicious mammographic finding, the addition of ultrasound allows further characterization of the lesion and determines whether ultrasound-guided biopsy is feasible. If the ultrasound findings are negative in the setting of a suspicious mammographic finding (BI-RADS category 4 or 5), stereotactic biopsy should be performed. Women Younger Than 40 Years Our recommended management algorithm for women younger than 40 years presenting with a palpable breast abnormality is summarized in Figure 8. According to the ACR appropriateness criteria, women years old presenting with a palpable breast mass may undergo either breast ultrasound or diagnostic mammography as the initial imaging examination. For this specific age group, whether to begin with ultrasound or mammography is at the discretion of the radiologist or referring provider. For women younger than 30 years presenting with a palpable breast mass, the ACR appropriateness criteria suggest breast ultrasound as the initial imaging modality. At our institution, we start with targeted ultrasound as the primary imaging modality for all women younger than 40 years who have a palpable breast lump. Because of the very low incidence of breast cancer among women younger than 40 years, the decreased sensitivity of mammography in dense breasts, and the desire to avoid unnecessary radiation in young women, mammography is not routinely performed. In a study of 830 women younger than 30 years with focal breast signs or symptoms, our group found a very low incidence of breast cancer (0.4%). Targeted ultrasound had 100% sensitivity and a 100% negative predictive value [37]. Among 954 women with symptoms who were years old, we similarly found high sensitivity (96%) and a high negative predictive value (99.9%) with little added value from adjunct mammography [5]. These findings are consistent with those of several other clinical research studies [38 40]. As with mammography, if a clearly benign cause of the palpable symptom is detected with targeted ultrasound, no further evaluation is needed. A mass with probably benign ultrasound features is managed with short-term follow-up as detailed earlier. If a sonographically suspicious finding is detected, ultrasound-guided core needle AJR:203, November

5 Lehman et al. biopsy should be performed. If the result is malignant, mammography of both breasts is indicated to screen for additional foci of malignancy. A mammogram should also be obtained if the ultrasound findings are negative but a dominant suspicious palpable mass is found at clinical examination. Pregnant and Lactating Women Most palpable masses associated with pregnancy and lactation are benign. Fibroadenomas are the most common solid masses in young women and can grow in response to increased estrogen levels during pregnancy. Benign lesions such as galactoceles and lactating adenomas may occur in lactating women. Mastitis and breast abscesses are also potential complications of breast-feeding [41]. Gestational breast cancer, defined as malignancy occurring during pregnancy, lactation, or within 1 year postpartum, occurs in approximately 1 in every 3000 pregnancies [42]. A palpable mass is the most common presenting symptom in women with gestational breast cancer [43, 44]. Thus, pregnant and lactating women with a palpable lump should be evaluated promptly. Targeted ultrasound should be the primary imaging study and has been reported to have high sensitivity (100%) in the detection of symptomatic gestational breast cancer [43, 44]. breast examination can be difficult because of the physiologic changes in the breast tissue that occur with pregnancy. If diagnostic mammography is indicated after the ultrasound examination, the gravid state should not preclude it. The radiation dose from a single mammographic examination is minimal, and the patient should be reassured of the negligible risk to the fetus [45]. A lead shield can be used to further reduce radiation exposure of the fetus. Image-guided biopsy should be performed on all suspicious (BI-RADS 4 or 5) lesions, and lactating patients should be informed about the theoretic but extremely low risk of a milk fistula. In pregnant women, completion of the diagnostic evaluation, including imageguided needle biopsy if needed, can be performed safely and effectively before delivery and should not be delayed for lesions deemed suspicious on the basis of clinical or imaging findings. Additional Special Scenarios Women with palpable breast lumps may have clinical presentations that warrant consideration of trauma or infection as a likely cause of the lump. In both scenarios, clinical management can be supported with imaging if the lump is not resolving as expected with surveillance or antibiotic therapy. Imaging evaluation in either clinical setting should follow the same process as for women presenting with lumps without a history of trauma or clinical signs or symptoms of infection (mammography first for women 40 years old and older, ultrasound first for women younger than 40 years). There is overlap in the imaging features of hematomas, abscesses, and malignancies. Thus, careful clinical and imaging follow-up should be performed to confirm complete resolution of all suspected hematomas and abscesses to avoid delays in the diagnosis of malignancy in clinical settings suspicious for trauma or infection. Coordination with the referring health care provider and clear communication with the patient support this process and protect against erroneous dismissal of cancer on the basis of the clinical scenario alone. When an abscess is suspected, image-guided drainage of the complex mass, particularly if larger than 2 3 cm, may speed recovery. Biopsy and Triple Test Score If feasible, ultrasound-guided core needle biopsy is the method of choice for tissue sampling of suspicious palpable breast lesions. It is highly sensitive and specific, comparable to open surgery, for palpable breast malignancies [46]. If a mammographically suspicious palpable lesion is occult at ultrasound examination, stereotactic core needle biopsy should be performed. Not surprisingly, image-guided core needle biopsy has much higher diagnostic accuracy than palpation-guided biopsy [47]. If the pathologic findings from the biopsy are concordant and benign, the risk of malignancy is negligible. Practices vary, but many imagers (including those at our institution) perform a single short-interval imaging follow-up evaluation at 6 months for early detection of the highly unlikely false-negative diagnosis. It is crucial to immediately recognize discordant results of a core needle biopsy [48]. Discrepancy between the pathologic result and the clinical and radiologic findings should prompt repeat core needle biopsy or excision. For practices without programs to support careful pathologic-imaging concordance, short-interval follow-up imaging is recommended for all benign biopsy results. Surgeons often use the triple test score to assess palpable breast abnormalities. It originally consisted of a clinical breast examination, fine-needle aspiration biopsy, and mammography. Modified versions have substituted core needle biopsy and ultrasound for aspiration and mammography [49, 50]. Each of the three components is assigned a score of 1, 2, or 3 for benign, suspicious, or malignant results. The sum of the three scores, or the triple test score, is considered a likely benign result if less than 5 and is considered highly suspicious for malignancy if greater than 5. The triple test score has been found to have high diagnostic performance. One study [49] showed both sensitivity and specificity of 100% for scores greater than or less than 5. There are major limitations to the method, however, and we advise against its routine use. There is substantial variation in the performance of the clinical breast examination and the interpretation of its findings, and there is also a lack of standardization [51]. In addition, the triple test requires tissue sampling in all cases, which is not indicated when careful imaging evaluation has documented negative, benign, or probably benign findings. Recommendations for Future Research Exciting technical advances and carefully performed clinical research studies in imaging will continue to guide more cost-effective, safe, and minimally invasive methods of caring for women with palpable breast lumps. The role of ultrasound to improve cancer detection and reduce the costs and morbidity of surgery in this patient population will continue to expand. Although there are concerns about possible overuse of mammography and advanced imaging, such as MRI and PET, in a variety of clinical situations, ultrasound is likely underused for effective evaluation of women with palpable breast lumps. In an era of careful attention to radiation exposure from imaging, as highlighted by the Image Wisely campaign, ultrasound is an ideal tool for accurate identification of cancer in women who present with a palpable breast lump. Whole-breast ultrasound techniques may support improved evaluation of a larger region of breast tissue in patients with symptoms and reduce concerns regarding operator dependence (variability across users) and the time associated with targeted handheld ultrasound. The current ACR appropriateness criteria recommend mammography as the initial imaging tool for women 40 years old and older 1146 AJR:203, November 2014

6 Imaging of Breast Abnormalities who have palpable lumps. It may be that ultrasound can be used as the first evaluation of these women if they have had a negative screening mammogram in the previous year and have mammographically dense breast tissue. research to clarify relevant and important best practice pathways is encouraged. Although there is growing literature on the best methods of screening women at increased risk of breast cancer, little attention has been given to differential management of women at high risk who present with palpable breast lumps. More research is needed in these populations to support careful treatment of women presenting with palpable lumps who are at high risk because of a family or personal history of breast cancer or a genetic mutation. Finally, it is essential that we address the barriers to care that women with self-detected breast lumps face, so that fewer women with a palpable breast lump have a delayed breast cancer diagnosis. Although controversy abounds in multiple issues regarding breast imaging and breast cancer treatment, there is universal agreement that women with palpable breast cancer do better when the tumor is identified and treated promptly. Conclusion Women presenting to breast imaging facilities with palpable breast lumps can be supported to consistently receive a highly accurate, minimally invasive approach to differentiating the minority of women with cancer in this clinical setting from the majority without cancer. Clear and effective communication between the patient, referring health care provider, and breast imager is essential to support best practices. Breast ultrasound is a highly effective imaging tool for determining the level of suspicion of palpable breast abnormalities and should be used for almost all women presenting with a palpable abnormality. Breast ultrasound should be increasingly considered as the primary imaging tool for women younger than 40 years. Breast MRI and other advanced imaging technologies likely have little to no role in the diagnostic evaluation of palpable breast abnormalities. Careful clinical followup with return to imaging or with biopsy if symptoms worsen is essential to support an effective program that minimizes unnecessary biopsies of women with negative or benign imaging findings. Following the ACR appropriateness criteria supports a safe, evidencebased approach to effective management of women presenting with palpable lumps. References 1. Barton MB, Elmore JG, Fletcher SW. Breast symptoms among women enrolled in a health maintenance organization: frequency, evaluation, and outcome. Ann Intern Med 1999; 130: Wernli KJ, Demartini WB, Ichikawa L, et al. Patterns of breast magnetic resonance imaging use in community practice. JAMA Intern Med 2014; 174: Dennis MA, Parker SH, Klaus AJ, Stavros AT, Kaske TI, Clark SB. 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How reliable is modern breast imaging in differentiating benign from malignant breast lesions in the symptomatic population? Clin Radiol 1999; 54: Moy L, Slanetz PJ, Moore R, et al. Specificity of mammography and US in the evaluation of a palpable abnormality: retrospective review. Radiology 2002; 225: Gumus H, Gumus M, Mills P, et al. ly palpable breast abnormalities with normal imaging: is clinically guided biopsy still required? Clin Radiol 2012; 67: Shetty MK, Shah YP, Sharman RS. Prospective evaluation of the value of combined mammographic and sonographic assessment in patients with palpable abnormalities of the breast. J Ultrasound Med 2003; 22: Shin JH, Han BK, Ko EY, Choe YH, Nam SJ. Probably benign breast masses diagnosed by sonography: is there a difference in the cancer rate according to palpability? AJR 2009; 192:[web] W187 W Harvey JA, Nicholson BT, Lorusso AP, Cohen MA, Bovbjerg VE. Short-term follow-up of palpable breast lesions with benign imaging features: evaluation of 375 lesions in 320 women. AJR 2009; 193: D Orsi CJ, Sickles EA, Mendelson EB, Morris EA et al. ACR BI-RADS Atlas, Breast Imaging Reporting and Data System. Reston, VA: American College of Radiology, 2013 AJR:203, November

7 Lehman et al. 30. Giess CS, Smeglin LZ, Meyer JE, Ritner JA, Birdwell RL. Risk of malignancy in palpable solid breast masses considered probably benign or low suspicion: implications for management. J Ultrasound Med 2012; 31: Graf O, Helbich TH, Fuchsjaeger MH, et al. Follow-up of palpable circumscribed noncalcified solid breast masses at mammography and US: can biopsy be averted? Radiology 2004; 233: Park YM, Kim EK, Lee JH, et al. Palpable breast masses with probably benign morphology at sonography: can biopsy be deferred? Acta Radiol 2008; 49: Smith GE, Burrows P. Ultrasound diagnosis of fibroadenoma: is biopsy always necessary? Clin Radiol 2008; 63: , discussion, Olsen ML, Morton MJ, Stan DL, Pruthi S. Is there a role for magnetic resonance imaging in diagnosing palpable breast masses when mammogram and ultrasound are negative? J Womens Health (Larchmt) 2012; 21: Yau EJ, Gutierrez RL, DeMartini WB, Eby PR, Peacock S, Lehman CD. The utility of breast MRI as a problem-solving tool. Breast J 2011; 17: Leung JW. MR imaging in the evaluation of equivocal clinical and imaging findings of the breast. Magn Reson Imaging Clin N Am 2010; 18: Loving VA, DeMartini WB, Eby PR, Gutierrez RL, Peacock S, Lehman CD. Targeted ultrasound in women younger than 30 years with focal breast signs or symptoms: outcomes analyses and management implications. AJR 2010; 195: Georgian-Smith D, Taylor KJ, Madjar H, et al. Sonography of palpable breast cancer. J Clin Ultrasound 2000; 28: Osako T, Iwase T, Takahashi K, et al. Diagnostic mammography and ultrasonography for palpable and nonpalpable breast cancer in women aged 30 to 39 years. Breast Cancer 2007; 14: Rahbar G, Sie AC, Hansen GC, et al. Benign versus malignant solid breast masses: US differentiation. Radiology 1999; 213: Hogge JP, De Paredes ES, Magnant CM, Lage J. Imaging and management of breast masses during pregnancy and lactation. Breast J 1999; 5: Keleher AJ, Theriault RL, Gwyn KM, et al. Multidisciplinary management of breast cancer concurrent with pregnancy. J Am Coll Surg 2002; 194: Robbins J, Jeffries D, Roubidoux M, Helvie M. Accuracy of diagnostic mammography and breast ultrasound during pregnancy and lactation. AJR 2011; 196: Taylor D, Lazberger J, Ives A, Wylie E, Saunders C. Reducing delay in the diagnosis of pregnancyassociated breast cancer: how imaging can help us. J Med Imaging Radiat Oncol 2011; 55: Sechopoulos I, Suryanarayanan S, Vedantham S, A D Orsi CJ, Karellas A. Radiation dose to organs and tissues from mammography: Monte Carlo and phantom study. Radiology 2008; 246: Yeow KM, Lo YF, Wang CS, Chang HK, Tsai CS, Hsueh C. Ultrasound-guided core needle biopsy as an initial diagnostic test for palpable breast masses. J Vasc Interv Radiol 2001; 12: Ward ST, Shepherd JA, Khalil H. Freehand versus ultrasound-guided core biopsies of the breast: reducing the burden of repeat biopsies in patients presenting to the breast clinic. Breast 2010; 19: Shah VI, Raju U, Chitale D, Deshpande V, Gregory N, Strand V. False-negative core needle biopsies of the breast: an analysis of clinical, radiologic, and pathologic findings in 27 consecutive cases of missed breast cancer. Cancer 2003; 97: Morris KT, Pommier RF, Morris A, et al. Usefulness of the triple test score for palpable breast masses. Arch Surg 2001; 136: ; discussion, Wai CJ, Al-Mubarak G, Homer MJ, et al. A modified triple test for palpable breast masses: the value of ultrasound and core needle biopsy. Ann Surg Oncol 2013; 20: Barton MB, Harris R, Fletcher SW. The rational clinical examination: does this patient have breast cancer? The screening clinical breast examination: should it be done? How? JAMA 1999; 282: Fig year-old woman with palpable right breast lump. A, Targeted ultrasound image at site of clinical concern shows 14-mm solid mass with oval shape, circumscribed margins, and uniformly hypoechoic echotexture. BI- RADS category 3 assessment was made. B, Ultrasound image shows appearance during core needle biopsy performed because patient preferred not to wait for 6-month follow-up ultrasound. Histopathologic analysis confirmed fibroadenoma, which was concordant with imaging findings. B 1148 AJR:203, November 2014

8 Imaging of Breast Abnormalities A B D Fig year-old woman with palpable right breast lump. A C, Whole-breast craniocaudal (A) and mediolateral oblique (B) and spot-magnification craniocaudal (C) mammograms show extremely dense breast tissue and no visible abnormality at site of clinical concern (BB marker). D, Targeted ultrasound image at site of clinical concern shows 32-mm solid hypoechoic mass with irregular shape and angular and indistinct margins. BI-RADS category 4 assessment was made. Histopathologic analysis of ultrasound-guided core needle biopsy specimen confirmed invasive ductal carcinoma. C AJR:203, November

9 Lehman et al. A B D Fig year-old woman with palpable right breast lump. A-C, Whole-breast craniocaudal (A) and mediolateral oblique (B) and spot-magnification mediolateral (C) mammograms show heterogeneously dense breasts and oval mass with partially circumscribed, partially obscured margins corresponding to area of clinical concern (BB marker). D, Targeted ultrasound image at site of clinical concern shows 28-mm simple cyst. BI-RADS category 2 (benign) assessment was made with recommendation for routine clinical follow-up. C 1150 AJR:203, November 2014

10 Imaging of Breast Abnormalities A Fig year-old breastfeeding woman 14 months postpartum with palpable right breast lump. A, Transverse targeted ultrasound image at site of clinical concern shows 11-mm complicated cyst. B, Longitudinal targeted ultrasound image shows shifting fat-fluid level consistent with galactocele. BI-RADS category 2 assessment was made, with recommendation for routine clinical follow-up. A Fig year-old woman with palpable left breast lump and associated ecchymosis. A C, Whole-breast craniocaudal (A) and mediolateral oblique (B) and spot-magnification craniocaudal (C) mammograms show almost entirely fatty breast tissue and focal asymmetry corresponding to area of clinical concern (BB marker). (Figure 5 continues on next page) B B C AJR:203, November

11 Lehman et al. Fig. 5 (continued) 55-year-old woman with palpable left breast lump and associated ecchymosis. D, Targeted ultrasound at site of clinical concern shows 25-mm complex mass most consistent with hematoma. BI-RADS category 3 assessment was made. E, Follow-up targeted ultrasound image 6 weeks after A D shows interval decrease in size of mass consistent with resolving hematoma. BI-RADS category 2 assessment was made with recommendation for routine clinical follow-up. D A Fig year-old woman with palpable left breast lump. A, Targeted ultrasound image at site of clinical concern shows 12-mm solid mass with oval shape, partially circumscribed and partially angular margins, and uniformly hypoechoic echotexture. BI-RADS category 4 assessment was made. B, Ultrasound image shows appearance during core needle biopsy. Histopathologic analysis revealed phyllodes tumor, which was concordant with imaging findings. E B 1152 AJR:203, November 2014

12 Imaging of Breast Abnormalities Fig. 7 Algorithm for management of palpable breast findings in women 40 years old and older. US = ultrasound. a Symptoms should be followed clinically; no further imaging workup is needed. b Core needle biopsy is a reasonable alternative to short-interval follow-up. Fig. 8 Algorithm for management palpable breast findings in women younger than 40 years. a Algorithm followed at our institution. Current American College of Radiology appropriateness criteria have separate algorithm for women years old, for whom first imaging modality can be either targeted ultrasound or diagnostic mammography. b Core needle biopsy is a reasonable alternative to short-interval follow-up. c Symptoms should be followed clinically. No further imaging workup indicated. d If no palpable dominant suspicious mass found at clinical examination. Suspicious BI-RADS 4 or 5 Core needle biopsy Suspicious US for biopsy planning Probably benign BI-RADS 3 US shortinterval follow-up b Probably benign Targeted US Benign BI-RADS 2 follow-up a Age 40 years Diagnostic mammogram with marker over palpable area Benign Only fatty tissue BI-RADS 2 follow-up a follow-up a BI-RADS 1 Negative BI-RADS 3 Mammographic shortinterval follow-up b Age < 40 years a Suspicious BI-RADS 4 or 5 Core needle biopsy Targeted ultrasound Probably benign BI-RADS 3 US shortinterval follow-up b Negative Targeted US Benign BI-RADS 2 follow-up a Suspicious Probably Benign Negative benign BI-RADS 4 or 5 Core needle biopsy Suspicious BI-RADS 4 or 5 Core needle biopsy BI-RADS 3 Short-interval follow-up b Probably benign BI-RADS 3 Mammographic short-interval follow-up b BI-RADS 2 follow-up c Benign BI-RADS 2 follow-up c Diagnostic mammography Negative BI-RADS 1 follow-up c Negative BI-RADS 1 follow-up a d FOR YOUR INFORMATION This article is available for CME and Self-Assessment (SA-CME) credit that satisfies Part II requirements for maintenance of certification (MOC). To access the examination for this article, follow the prompts associated with the online version of the article. AJR:203, November

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