Ultrasound Int Open 2016; 02(03): E83-E89
DOI: 10.1055/s-0042-110657
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Clinical Data as an Adjunct to Ultrasound Reduces the False-Negative Malignancy Rate in BI-RADS 3 Breast Lesions

S. Ackermann
1   Gynecology & Obstetrics, Hôpital de Morges, Morges, Switzerland
C.-A. Schoenenberger
2   Department of Chemistry, University of Basel, Basel, Switzerland
R. Zanetti-Dällenbach
3   Gynecology & Obstetrics, University Hospital Basel, Basel, Switzerland
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Weitere Informationen


received 16. Dezember 2015

accepted 06. Juni 2016

19. Juli 2016 (online)



Ultrasound (US) is a well-established diagnostic procedure for breast examination. We investigated the malignancy rate in solid breast lesions according to their BI-RADS classification with a particular focus on false-negative BI-RADS 3 lesions. We examined whether patient history and clinical findings could provide additional information that would help determine further diagnostic steps in breast lesions.

Materials and Methods:

We conducted a retrospective study by exploring US BI-RADS in 1469 breast lesions of 1201 patients who underwent minimally invasive breast biopsy (MIBB) from January 2002 to December 2011.


The overall sensitivity and specificity of BI-RADS classification was 97.4% and 66.4%, respectively, with a positive (PPV) and negative predictive value (NPV) of 65% and 98%, respectively. In 506 BI-RADS 3 lesions, histology revealed 15 malignancies (2.4% malignancy rate), which corresponds to a false-negative rate (FNR) of 2.6%. Clinical evaluation and patient requests critically influenced the further diagnostic procedure, thereby prevailing over the recommendation given by the BI-RADS 3 classification.


Clinical criteria including age, family and personal history, clinical examination, mammography and patient choice ensure adequate diagnostic procedures such as short-term follow-up or MIBB in patients with lesions classified as US-BI-RADS 3.

  • References

  • 1 Hooley RJ, Greenberg KL, Stackhouse RM et al. Screening US in patients with mammographically dense breasts: initial experience with Connecticut Public Act 09-41. Radiology 2012; 265: 59-69
  • 2 Houssami N, Irwig L, Simpson JM et al. Sydney Breast Imaging Accuracy Study: Comparative sensitivity and specificity of mammography and sonography in young women with symptoms. AJR American journal of roentgenology 2003; 180: 935-940
  • 3 Berg WA, Blume JD, Cormack JB et al. Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. Jama 2008; 299: 2151-2163
  • 4 Berg WA, Zhang Z, Lehrer D et al. Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk. Jama 2012; 307: 1394-1404
  • 5 Shin JH, Han BK, Ko EY et al. Probably benign breast masses diagnosed by sonography: is there a difference in the cancer rate according to palpability?. AJR American journal of roentgenology 2009; 192: W187-W191
  • 6 Harvey JA, Nicholson BT, Lorusso AP et al. Short-term follow-up of palpable breast lesions with benign imaging features: evaluation of 375 lesions in 320 women. AJR American journal of roentgenology 2009; 193: 1723-1730
  • 7 Berg WA, Blume JD, Cormack JB et al. Operator dependence of physician-performed whole-breast US: lesion detection and characterization. Radiology 2006; 241: 355-365
  • 8 ACoRACR ACR BI-RADS® Atlas. Breast Imaging Reporting and Data System. 5rd ed. Reston, VA: American College of Radiology; ed. 2013
  • 9 Graf O, Helbich TH, Hopf G et al. Probably benign breast masses at US: is follow-up an acceptable alternative to biopsy?. Radiology 2007; 244: 87-93
  • 10 Kim SJ, Ko EY, Shin JH et al. Application of sonographic BI-RADS to synchronous breast nodules detected in patients with breast cancer. AJR American journal of roentgenology 2008; 191: 653-658
  • 11 Lehman CD, Lee CI, Loving VA et al. Accuracy and value of breast ultrasound for primary imaging evaluation of symptomatic women 30–39 years of age. AJR American journal of roentgenology 2012; 199: 1169-1177
  • 12 Hille H, Vetter M, Hackeloer BJ. The accuracy of BI-RADS classification of breast ultrasound as a first-line imaging method. Ultraschall in der Medizin 2012; 33: 160-163
  • 13 Foxcroft LM, Evans EB, Porter AJ. The diagnosis of breast cancer in women younger than 40. Breast 2004; 13: 297-306
  • 14 Madjar H, Becker S, Doubek K et al. Impact of breast ultrasound screening in gynecological practice. Ultraschall in der Medizin 2010; 31: 289-295
  • 15 ACR ACoR. ACR BI-RADS® Ultrasound Atlas. Breast Imaging Reporting and Data System. 2003
  • 16 Madjar H, Ohlinger R, Mundinger A et al. BI-RADS-analogue DEGUM criteria for findings in breast ultrasound – consensus of the DEGUM Committee on Breast Ultrasound. Ultraschall in der Medizin 2006; 27: 374-379
  • 17 Mendelson EB, Berg WA, Merritt CR. Toward a standardized breast ultrasound lexicon, BI-RADS: ultrasound. Seminars in roentgenology 2001; 36: 217-225
  • 18 Team RC. R: A language and environment for statistical computing. 2014;
  • 19 Guth U, Huang DJ, Huber M et al. Tumor size and detection in breast cancer: Self-examination and clinical breast examination are at their limit. Cancer detection and prevention 2008; 32: 224-228
  • 20 Costantini M, Belli P, Lombardi R et al. Characterization of solid breast masses: use of the sonographic breast imaging reporting and data system lexicon. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine 2006; 25: 649-59 quiz 61
  • 21 Heinig J, Witteler R, Schmitz R et al. Accuracy of classification of breast ultrasound findings based on criteria used for BI-RADS. Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology 2008; 32: 573-578
  • 22 Bullier B, MacGrogan G, Bonnefoi H et al. Imaging features of sporadic breast cancer in women under 40 years old: 97 cases. European radiology 2013; 23: 3237-3245
  • 23 Ha R, Kim H, Mango V et al. Ultrasonographic features and clinical implications of benign palpable breast lesions in young women. Ultrasonography 2015; 34: 66-70
  • 24 Maxwell AJ, Pearson JM.. Criteria for the safe avoidance of needle sampling in young women with solid breast masses. Clinical radiology 2010; 65: 218-222
  • 25 Patterson SK, Neal CH, Jeffries DO et al. Outcomes of solid palpable masses assessed as BI-RADS 3 or 4A: a retrospective review. Breast cancer research and treatment 2014; 147: 311-316
  • 26 Giess CS, Smeglin LZ, Meyer JE et al. Risk of malignancy in palpable solid breast masses considered probably benign or low suspicion: implications for management. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine 2012; 31: 1943-1949
  • 27 Rhiem K, Flucke U, Schmutzler RK. BRCA1-associated breast carcinomas frequently present with benign sonographic features. AJR American journal of roentgenology. 2006; 186: E11-E12 author reply E2–E3
  • 28 Boisserie-Lacroix M, Mac Grogan G, Debled M et al. Radiological features of triple-negative breast cancers (73 cases). Diagnostic and interventional imaging 2012; 93: 183-190
  • 29 Dogan BE, Gonzalez-Angulo AM, Gilcrease M et al. Multimodality imaging of triple receptor-negative tumors with mammography, ultrasound, and MRI. AJR American journal of roentgenology 2010; 194: 1160-1166
  • 30 Bosch AM, Kessels AG, Beets GL et al. Interexamination variation of whole breast ultrasound. The British journal of radiology 2003; 76: 328-331
  • 31 Fleury EF. The importance of breast elastography added to the BI-RADS (5th edition) lexicon classification. Revista da Associação Médica Brasileira 2015; 61: 313-316