Lysine-urethane-based tissue adhesion for mastectomy-an approach to reducing the seroma rate?

PURPOSE: Postoperative seromas are a problem in the surgical treatment of breast cancer. The aim of the study was to evaluate whether the lysine-urethane-based tissue adhesive TissuGlu® without drainage is equal/ non-inferior to standard mastecomy with drainage. METHODS: The study was designed as a prospective, randomized, multicentre non-inferiority study comparing the use of TissuGlu® without drainage with standard wound care with a drain insertion in ablative breast procedures. The number of clinical interventions, quality of life and wound complications were followed-up for 90 days in both groups. RESULTS: Although the statistical power was not reached, twice as many clinical interventions were performed in the TissuGlu® group than in the drainage group, especially aspirations of clinically relevant seromas (p = 0.014). The TissuGlu® group produced overall less wound fluid, but developed a clinically relevant seroma (100% vs. 63%) which made an intervention necessary. Less hospitalisation time was observed in the TissuGlu® group, but the complication rate was higher. There was no significant difference in regards to postoperative pain. In summary the non-inferiority of TissuGlu® compared to standard drainage couldn't be reached. DISCUSSION: The present evaluation shows no advantage of the tissue adhesive TissuGlu® in terms of seroma formation and frequency of intervention compared to a standard drainage for mastectomies, but the shorter inpatient stay certainly has a positive effect on the quality of life.

Breast reconstruction and revision surgery for implant-associated breast deformities using porcine acellular dermal matrix: a multicenter study of 156 cases.

BACKGROUND: Acellular dermal matrix is increasingly used as caudolateral coverage for breast implants in immediate breast reconstruction after skin-sparing mastectomy or in the correction of implant-associated breast deformities. Matrices of human, bovine, and porcine origin are available. The purpose of this retrospective multicenter study was to report experiences with porcine acellular dermal matrices, as only limited data can be found in the literature. METHODS: In the hospital databases of five institutions, 127 patients were identified who underwent breast reconstructions in 156 breasts using an acellular porcine dermal matrix. Medical records were reviewed. Patients were divided into three groups: immediate expander-implant or direct to implant reconstructions (n = 98), delayed expander-implant reconstructions (n = 14), and revision surgery for implant-associated breast deformities (n = 44). RESULTS: With a mean follow-up of 19.6 months, total major complication rate was 7.1 %: implant loss (3.2 %), skin flap necrosis (2.6 %), delayed skin healing (2.6 %), hematoma (1.9 %), seroma (1.3 %), infection (0.6 %), and capsular contracture (0.6 %). Total minor complication rate was 22.9 %, with seroma being the most frequent complication (19.2 %). In the group of immediate breast reconstructions, 20.4 % of the breasts had received radiotherapy in the past. These patients exhibited a significantly higher rate of seroma than patients without prior radiotherapy (35.0 vs. 14.9 %, p = 0.031). CONCLUSIONS: Complication rates using porcine acellular dermal matrix in breast reconstruction are comparable to complication rates reported in studies using human acellular dermal matrices. Thus, porcine acellular dermal matrices can safely be applied in breast reconstructive surgery.

[Evaluation of the nationwide DEGUM breast ultrasound training program]. / Evaluation der DEGUM-Mammasonografiekurse nach objektivierbaren Kriterien.

PURPOSE: The aim of this study was to evaluate the quality standard of the nationwide breast ultrasound training program of the German Society of Ultrasound in Medicine (DEGUM) through objective parameters. MATERIALS AND METHODS: 10 quality criteria, based on the recommendations of The National Association of Statutory Health Insurance Physicians (KBV), were defined for this study. All training units of the DEGUM received a questionnaire. The questionnaires and training material were analyzed. RESULTS: All units met the required criteria pertaining to the trainer's qualification, duration per training course and the maximum number of participants per ultrasound machine. Only 1 course did not fulfill the required 50 % practical training time. The requirements to participate in the graduate course (200 self-made and documented cases) were not clearly conceived and a defined training log could be improved. CONCLUSION: DEGUM breast ultrasound training offers trainees a high level of education based on the requirements of the KBV. Despite the high quality of training, the content of course announcements could be improved and an official and structured educational index could be meaningful.

ShearWave™ Elastography BE1 multinational breast study: additional SWE™ features support potential to downgrade BI-RADS®-3 lesions.

PURPOSE: To determine the benefit of ShearWave™ Elastography (SWE™) in the ultrasound characterization of BI-RADS® 3 breast lesions in a diagnostic population. MATERIALS AND METHODS: 303 BI-RADS® 3 lesions (mean size: 13.2 mm, SD: 7.5 mm) from the multicenter BE1 prospective study population were analyzed: 201 (66%) had cytology or core biopsy, and the remaining 102 had a minimum follow-up of one year; 8 (2.6%) were malignant. 7 SWE features were evaluated with regard to their ability to downgrade benign BI-RADS® 3 masses. The performance of each SWE feature was assessed by evaluating the number of lesions correctly reclassified and the impact on cancer rates within the new BI-RADS® 3' lesion group. RESULTS: No malignancies were found with an E-color "black to dark blue", which allowed the downgrading of 110/303 benign masses (p < 0.0001), with a non-significant increase in BI-RADS® 3' malignancy rate from 2.6% to 4.1%. E-max ≤ 20 kPa (2.6 m/s) was able to downgrade 48/303 (p < 0.0001) lesions with a lower increase in BI-RADS® 3' malignancy rate (3.1%). No other SWE features were useful for reclassifying benign BI-RADS® 3 lesions. CONCLUSION: Applying simple reclassification rules, SWE assessment of the maximum stiffness of lesions allowed the downgrading of a sub-group of benign BI-RADS® 3 lesions. This was accompanied by a non-significant increase in the malignancy rate in the new BI-RADS® 3 class.

EFSUMB guidelines and recommendations on the clinical use of ultrasound elastography. Part 1: Basic principles and technology.

The technical part of these Guidelines and Recommendations, produced under the auspices of EFSUMB, provides an introduction to the physical principles and technology on which all forms of current commercially available ultrasound elastography are based. A difference in shear modulus is the common underlying physical mechanism that provides tissue contrast in all elastograms. The relationship between the alternative technologies is considered in terms of the method used to take advantage of this. The practical advantages and disadvantages associated with each of the techniques are described, and guidance is provided on optimisation of scanning technique, image display, image interpretation and some of the known image artefacts.

EFSUMB guidelines and recommendations on the clinical use of ultrasound elastography. Part 2: Clinical applications.

The clinical part of these Guidelines and Recommendations produced under the auspices of the European Federation of Societies for Ultrasound in Medicine and Biology EFSUMB assesses the clinically used applications of all forms of elastography, stressing the evidence from meta-analyses and giving practical advice for their uses and interpretation. Diffuse liver disease forms the largest section, reflecting the wide experience with transient and shear wave elastography . Then follow the breast, thyroid, gastro-intestinal tract, endoscopic elastography, the prostate and the musculo-skeletal system using strain and shear wave elastography as appropriate. The document is intended to form a reference and to guide clinical users in a practical way.

Laparoscopic sacropexy: a retrospective analysis of the subjective outcome in 310 cases.

Background and Objective. The aim of this study was to assess the subjective outcome following laparoscopic sacropexy. Methods. We performed a retrospective cohort study among women treated for descensus with laparoscopic sacropexy between January 2000 and December 2007. 310 patients received questionnaires during followup assessing major pre- and postoperative symptoms and overall satisfaction. Results. 214 (69%) patients responded to the questionnaire. Mean followup was 24.5 months. The number of patients with back or lower abdominal pain, foreign body sensation in the vagina and prolapse-related symptoms, urinary symptoms, vaginal and bladder infections, and the need for pessary usage decreased significantly postsurgically. Bowel symptoms increased slightly but not significantly. Two years after surgery, nearly 2 thirds of the women were satisfied or very satisfied with the outcome. Conclusion. Laparoscopic sacropexy is an effective treatment of descensus, with favorable or satisfactory subjective outcomes.

Diagnostic value of palpation, mammography, and ultrasonography in the diagnosis of fibroadenoma: impact of breast density, patient age, ultrasonographic size, and palpability.

PURPOSE: This retrospective study aimed to assess the diagnostic value of mammography, breast ultrasonography, and palpation in diagnosing fibroadenomas, making consistent use of the BI-RADS classification. The impact of breast density, patient age, and the size and palpability of the mass will be evaluated. PATIENTS AND METHODS: Between January 2000 and December 2009, a total of 339 fibroadenomas suitable for inclusion in this study were diagnosed and histologically verified at our institution. Based on their BI-RADS or BI-RADS analog classification, all lesions were categorized as benign or malignant. These results were compared to the corresponding histopathological findings. Specificities were calculated for each of the abovementioned parameters. Chi-square test results with p-values < 0.05 were considered significant. Congruence between mammography and ultrasonography was assessed based on Cohen's kappa. RESULTS: Palpation had a specificity of 100 %, mammography 83.9 %, and ultrasonography 88.2 %. Considering the parameters under investigation, ultrasonography is superior to mammography. The specificity of the ultrasonographic assessment "benign" vs. "malignant" varied with patient age and palpability of the lesion (p = 0.001 and p = 0.025). Mammography and ultrasonography were most congruent for lesions rated ACR 1 - 2 and for lesions > 1.9 cm (κ = 0.464, κ = 0.444). CONCLUSION: For diagnosing fibroadenomas, ultrasonography is more specific than mammography when all examined variables are taken into account. Ultrasonography should therefore be favored, especially in younger patients. One needs to be aware of the effects of palpability and patient age on the ultrasonographic differentiation "malignant" vs. "benign". In some cases, mammography should be considered as an adjunct.

Sensitivity and specificity of preoperative ultrasonography for diagnosing nodal metastases in patients with breast cancer.

PURPOSE: Rational therapy planning should aim to minimize the rate of axillary lymph node dissection (ALND) in patients without metastatic disease. By the same token, the frequency of sentinel lymph node biopsies (SLNB) should not be unnecessarily high in patients with axillary node disease. Preoperative axillary ultrasonography is a generally available noninvasive technique for assessing nodal status. MATERIALS AND METHODS: Based on retrospective data, we analyzed the sensitivity, specificity, positive and negative predictive value, and efficiency of preoperative ultrasonography US. A total of 429 axillary ultrasonographic examinations were included, and the management decisions were based on the ultrasonographic findings. Patients with suspicious US results were scheduled for ALND, while patients with unremarkable findings underwent SLNB. RESULTS: Axillary metastases were found in 146 of 429 (34 %) cases. In 75 of 429 (17 %) axillary examinations, ultrasonography revealed suspicious findings. In these cases, we proceeded with ALND, thereby reducing the number of SLNB by 17 %. 219 of 429 cases were classified correctly as not having metastasis, thus lowering the rate of ALND, which is associated with higher postoperative morbidity, by 51 %. Preoperative ultrasonography had a sensitivity of 53.6 %, specificity of 75.5 %, and a positive predictive value of 77.3 %. The negative predictive value was 51.3 % and the efficiency was 68.5 %. CONCLUSION: Ultrasonography is a moderately sensitive, but quite specific, preoperative method for assessing the axillary lymph nodes.

Breast lesion sizing by B-mode imaging and sonoelastography in comparison to histopathological sizing--a prospective study.

PURPOSE: This prospective study evaluates whether sonoelastography can improve B-mode ultrasonographic sizing of breast tumors. Precise measuring is important for effective therapy planning for breast cancer patients. MATERIALS AND METHODS: The size of 100 surgically excised breast lesions (92 patients: 77 malignant, 23 benign) was compared to preoperative measurements. Lesions were imaged with both ultrasonographic techniques in identical planes. The largest sizes measured with each modality were compared to the largest histopathological measurements. The interobserver variability was also computed from measurements made by two examiners assessing identical planes. RESULTS: Both ultrasonographic measuring techniques underestimate lesion size. The sonoelastography measurements were within ± 5 mm of the histological size in 70.1 % of malignant lesions, and the B-mode measurements in 57.1 % of cases. Sonoelastography leads to more accurate measurements of 13.0 % of cases (statistically not significant). A total of 22 lesions were also imaged by a second examiner. Sonoelastography had 27.3 % less interobserver variability (examiners agreed in 36.4 % of sonoelastography and in 9.1 % of B-mode results). CONCLUSION: In this study there is no significant advantage of sonoelastography, although a tendency is apparent. The low interobserver variability also favors sonoelastography for preoperative diagnostics, since it may be less dependent on the observer than conventional B-mode imaging. The results of this prospective study require validation in a prospective multicenter study with larger case numbers.

Sonoelastography in the diagnosis of malignant and benign breast lesions: initial clinical experiences.

PURPOSE: This prospective study aimed to compare sonoelastography, B-mode ultrasonography, and mammography in terms of their ability to distinguish benign from malignant breast lesions. We also assessed how the diagnostic value of sonoelastography differs between palpable and clinically occult lesions. MATERIALS AND METHODS: Evaluation revealed a total of 97 lesions (66 benign; 31 malignant) without histological confirmation at the time of the initial examination. The sensitivity, specificity, positive (PPV) and negative predictive value (NPV) as well as efficiency were calculated. These parameters were separately assessed for palpable lesions and for non-palpable lesions. We subsequently compared these results. RESULTS: Sonography had a sensitivity of 97% and a specificity of 82% (PPV: 71 %, NPV: 98%, efficiency: 87%). For mammography, the respective figures were 84% and 89% (PPV: 79%, NPV: 92%, efficiency: 88%). Sonoelastography had a sensitivity of 71% and a specificity of 48% (PPV: 39%, NPV: 78%, efficiency: 56%). The combination of sonography and sonoelastography yielded a sensitivity of 100% and a specificity of 38% (PPV: 43%, NPV: 100%, efficiency: 58%). The sensitivity and specificity were not statistically different between the groups of palpable and non-palpable lesions. CONCLUSION: Sonoelastography is easily performed and not very time-consuming. Used by itself, the method is not more efficacious than alternative techniques. When used in conjunction with B-mode ultrasonography, the latter's sensitivity was increased, albeit at the expense of specificity.

Diagnostic value of palpation and ultrasonography for diagnosing breast cancer recurrence after mastectomy--a comparison.

PURPOSE: According to the current interdisciplinary S 3 guideline for breast cancer diagnostics, treatment, and follow-up (1st update 2008), palpation is one of the diagnostic mainstays for follow-up examinations after mastectomy. Although recommended in the manuscript, regular ultrasonographic examinations are neither explicitly mentioned in the statement nor in the follow-up plan. In ambiguous cases, MRI can serve as a supplementary diagnostic method. In order to evaluate the value of palpation and ultrasonography for diagnosing recurrent disease after mastectomy, we analyzed the sensitivity of each method individually and the sensitivity of both methods combined. MATERIALS AND METHODS: Over a 12-year time span, histological data from 57 patients suspected to have recurrent disease after mastectomy (benign lesions: n = 15, 26.3% malignant lesions: n = 42, 73.7%) were collected. Prior to biopsy, the benign versus malignant character of all lesions was assessed by palpation and ultrasonography (BI-RADS). Sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv), and efficacy were calculated using a contingency table. RESULTS: Palpation had a sensitivity of 85.7 % and a specificity of 6.7% the respective figures for ultrasonography were 90.5% and 46.7%. The sensitivity of palpation and ultrasonography combined was 100%, i. e. 14.3% higher than the sensitivity of palpation alone. Five cases of recurrent disease which remained undetected by palpation were only recognized by ultrasonography. CONCLUSION: In agreement with several other studies, the results of our retrospective study show that ultrasonography is superior to palpation for diagnosing recurrent disease after mastectomy. Prospective multicenter studies are needed to evaluate ultrasonographic follow-up before an amendment of the current S 3 guidelines can be recommended with a high degree of evidence.

Selective microdochectomy after ductoscopic wire marking in women with pathological nipple discharge.

BACKGROUND: To investigate the diagnostic reliability of selective microdochectomy after direct ductoscopic wire marking of suspect lesions in patients with pathological nipple discharge. METHODS: Selective microdochectomy due to pathological discharge was performed in 33 patients with mean age of 51.7 years. Ductoscopes of 0.9 and 1.1 mm in diameter with a channel for wire marking were used. Only patients without sonographic or mammographic correlation for the discharge were included. The pathologic mammary duct was wire marked and extirpated under direct visual guidance via the ductoscope. The histological results were compared with cytology, galactography and ductoscopy. RESULTS: In 24 out of 33 cases (72%) an intraductal, epithelial proliferation was found histologically. The following sensitivities for intraductal, epithelial proliferations could be determined: cytology 4%, galactography 74%, and ductoscopy 78%. CONCLUSION: The method allows selective microdochectomy of the pathological duct and the intraductal proliferation under visual guidance. The resection volume can be reduced in contrast to the unselective ductectomy after injection of methylene blue.

[Spargelstangenuntersuchungen zur Haupterntezeit auf Infektionen mitFusarium spp. und Kontaminationen mit Fumonisin B1 Investigation on asparagus spears during the main harvest byFusarium spp.- infections and contamination by Fumonisin B1].

Asparagus spears collected from a total of six commercial plantings in Austria during the main harvest periods in May and June of 2003 and 2004 were examined for endophytic colonization byFusarium spp., particularlyF. proliferatum. Potentially toxigenic fungi such asF. proliferatum were isolated and identified by morphological characteristics using light microscopy. Fumonisin B1 inF. proliferatum-infected asparagus spears was detected with IAS-HPLC-FLD or HPLC-MS/MS. The identity of endophytic fungi colonizing of a total of 816 individual spears was determined. The incidence of infection byF. proliferatum and otherFusarium spp. was highly dependent on location and sampling date. The dominantFusarium species among the endophytic microflora wasF. oxysporum. Other frequently isolated species includedF. proliferatum, F. sambucinum, F. culmorum, F. avenaceum andF. equiseti. The incidence ofF. proliferatum-infected asparagus spears was less than 10% at four of the six sampling locations. At the two remaining locations, 20-47% of the spears examined were infected withF. proliferatum. Further exploration of FB1 generation in asparagus is required because the low levels of FB1 (10-50 (µg/kg) detected in harvested spears in 2003 and 2004 cannot be explained by the results of this study.

Recurrent disease after breast preserving therapy (BPT) and radiation therapy for breast cancer--diagnostic yield of palpation, mammography and ultrasonography.

PURPOSE: According to the S-3 guidelines for the diagnosis and treatment of breast cancer, only palpation and mammography are mandatory follow-up examinations. Ultrasonography is only mentioned as an optional technique. Aiming to elucidate the diagnostic yield for detecting recurrent disease after breast-preserving therapy (BPT) and radiation treatment, we analysed the sensitivity of palpation, mammography, ultrasonography, and combinations of these methods. MATERIALS AND METHODS: Over a period of 12 years, 27 suspicious lesions in patients status post BPT and radiation therapy were biopsied (histologic results: 16 benign lesions: 59.3 %, 11 malignant lesions: 40.7 %). Prior to biopsy, the benign or malignant character of each lesion was predicted by palpation, mammography and ultrasonography (BIRADS). Sensitivity, specifity, positive predictive value (ppv), negative predictive value (npv), and efficiency were calculated from a contingency table. RESULTS: For lesions status post BPT and radiation treatment, palpation had a sensitivity of 72.7 % and was 25 % specific. For mammography, the respective values were 36.4 % and 87.5 %, and for ultrasonography 90.9 % and 68.8 %. Palpation and mammography combined were 81.8 % sensitive and had a specificity of 6.2 %. The computed sensitivity for the 3 methods applied together was 100 %. Adding ultrasonography to palpation and mammography therefore increases sensitivity by 18.2 %. CONCLUSION: For diagnosing recurrent disease in patients status post BPT and radiation therapy, ultrasonography is superior to palpation and/or mammography and should become an obligatory follow-up tool. The role of mammographic follow-up appears overrated and the role of ultrasonographic assessment underrated. The S-3 guidelines will need to be changed accordingly.

Ultrasound and mammography guided wire marking of non-palpable breast lesions: analysis of 741 cases.

PURPOSE: Aim of the study were to evaluate the success of ultrasound and mammography guided wire marking of non-palpable breast lesions and the results of specimen mammography/ultrasonography, completeness of resection, and number of secondary resections (during the initial surgical session and as a separate intervention) were analysed. MATERIALS AND METHODS: Between May 1994 and December 2004, 668 women with 741 non-palpable breast lesions underwent surgery at the Greifswald University Department of Gynaecology and Obstetrics. Ultrasound directed wire marking was used in 418, mammography directed marking in 284 cases. In 39 lesions, both techniques were combined. RESULTS: Out of all lesions approached with ultrasound directed wire marking, 88 (21.1 %) were malignant. Among lesions marked during mammography, 52 (19.3 %) were malignant. Specimen ultrasonography indicated that 90.9 % of lesions were resected completely. Specimen mammography demonstrated complete resection in 89.1 %. On histological examination, 19.5 % of the malignant lesions marked with sonographic guiding and 36.5 % of the malignant lesions marked with mammographic guiding did not have clear margins. Secondary resections (during the first procedure) for incomplete specimens were needed in 10 patients in whom sonographic localisation had been used, and in 25 patients in whom mammographic localisation had been employed. A second surgical session for secondary resection was required in 5.5 % of lesions marked with ultrasound and in 12.3 % of lesions marked with mammography guidance. CONCLUSION: Sonography directed wire localisation appears to be superior to the respective mammographic method. Ultrasound guided wire marking should be considered the preferred method for all mammographic lesions with an ultrasonographic equivalent and no micro-calcifications.

Radial scar/complex sclerosing lesion of the breast--value of ultrasound.

PURPOSE: Although benign, radial scar/complex sclerosing adenosis is a lesion which histopathologically resembles tubular carcinoma. On physical examination, it is difficult to distinguish radial scar from a malignant tumour. Mammography cannot differentiate radial scar from malignancy. This clinical study aims to delineate the role of preoperative ultrasonography with emphasis on the question whether ultrasonography could lower the number of false-positive readings and therefore the number of open biopsies required. MATERIALS AND METHODS: In this examination, we present the clinical, mammographic, ultrasonographic, and histopathological features of 6 cases of radial scars. RESULTS: Although most authors describe radial scars as non-palpable, 2 of 6 lesions were indeed palpable. On mammograms, radial scars have a spiculated appearance, a feature observed in all of our cases. Numerous ultrasonographic characteristics are listed in the literature, but ultrasonography is not reported to have clear-cut advantages. CONCLUSION: Although this study did not elucidate any unique ultrasonographic features to characterise these lesions, the analysis of all ultrasonographic results made us recognise a set of "nearly specific ultrasonographic features" of radial scars. Current B-mode imaging does not appear to lead to the desirable reduction of the rate of unnecessary open biopsies.

Non-palpable breast lesions in asymptomatic women: diagnostic value of initial ultrasonography and comparison with mammography.

AIM: This prospective double-blind study was designed to assess (i) if primary breast screening by ultrasonography is capable of detecting breast cancer independent of tissue density and (ii) if the rate of unnecessary biopsies remains acceptable when diagnostics are based on ultrasonography. PATIENTS AND METHODS: Bilateral breast ultrasonography was performed in 448 asymptomatic women as the initial diagnostic method. Sonograms were interpreted using a set of standardized diagnostic criteria. Subsequently, mammograms were obtained. The radiologists reading the mammograms were blinded to the sonographic results. RESULTS: Overall, 3 non-palpable breast cancers were detected by ultrasound and mammography. All 3 ultrasonographically detected breast cancers were smaller than 1 cm (0.7, 0.7, 0.6 cm). All 3 carcinomas were correctly detected by both methods. For ultrasonography, the false positive rate was 1.1% (n=5) and for mammography 0.6% (n=3). When both methods were combined, the rate of unnecessary open biopsies was 1.6% (n=7). The ratio of benign to malignant lesions was 3.7/1. CONCLUSION: Without prior mammography, primary high-resolution breast ultrasonography is capable of detecting non-palpable breast carcinomas in asymptomatic women at an early stage. The rate of unnecessary open biopsies is low and the ratio of benign to malignant biopsies acceptable.

Real-time elastography--an advanced method of ultrasound: First results in 108 patients with breast lesions.

OBJECTIVES: To evaluate whether real-time elastography, a new, non-invasive method for the diagnosis of breast cancer, improves the differentiation and characterization of benign and malignant breast lesions. METHODS: Real-time elastography was carried out in 108 potential breast tumor patients with cytologically or histologically confirmed focal breast lesions (59 benign, 49 malignant; median age, 53.9 years; range, 16-84 years). Tumor and healthy tissue were differentiated by measurement of elasticity based on the correlation between tissue properties and elasticity modulus. Evaluation was performed using the three-dimensional (3D) finite element method, in which the information is color-coded and superimposed on the B-mode ultrasound image. A second observer evaluated the elastography images, in order to improve the objectivity of the method. The results of B-mode scan and elastography were compared with those of histology and previous sonographic findings. Sensitivities and specificities were calculated, taking histology as the gold standard. RESULTS: B-mode ultrasound had a sensitivity of 91.8% and a specificity of 78%, compared with sensitivities of 77.6% and 79.6% and specificities of 91.5% and 84.7%, respectively, for the two observers evaluating elastography. Agreement between B-mode ultrasound and elastography was good, yielding a weighted kappa of 0.67. CONCLUSIONS: Our initial clinical results suggest that real-time elastography improves the specificity of breast lesion diagnosis and is a promising new approach for the diagnosis of breast cancer. Elastography provides additional information for differentiating malignant BI-RADS (breast imaging reporting and data system) category IV lesions.