Imaging-histologic discordance after sonographically guided percutaneous breast biopsy: a prospective observational study

The objective of this study was to determine the frequency of imaging-histologic discordance and to compare the frequency of carcinoma between concordant and discordant lesions in sonographically (US)-guided 14-gauge core needle biopsies (CNBs). From January 2005 to December 2006, we performed US-guided 14-gauge automated CNB on 3339 breast lesions and obtained benign results in 2194 cases. Five radiologists prospectively reviewed the pathologic reports in conjunction with the imaging. We included a total of 1588 lesions that were either excised (n = 658) or followed up for at least 2 years (n = 930) after CNB. We evaluated the rate of discordance and the clinical findings for both discordant and concordant lesions. We also analyzed the clinical and imaging differences between the upgrade and non-upgrade groups. Imaging-histologic discordance was present in 103 of 1588 (6.5%) lesions. The upgrade rate was 6.8% (7/103) in discordant lesions and 0.4% (6/1485) in concordant lesions (p < 0.01). Lesion size, Breast Imaging, Reporting and Data System (BI-RADS) category and the presence or absence of symptoms was statistically significant between the upgrade and non-upgrade groups in discordant cases (p < .05). Imaging-histologic discordance is an indication for excision because it has a higher upgrade rate than concordant lesions.     

Shear-Wave Elastography: Could it be Helpful for the Diagnosis of Non-Mass-Like Breast Lesions?

The goal of this study was to analyze the diagnostic performance of shear wave elastography (SWE) in differentiation of benign and malignant non-mass-like (NML) breast lesions. Three hundred sixteen consecutive breast lesions in 305 patients who have been scheduled for ultrasound (US)-guided core needle biopsy or vacuum-assisted biopsy or surgical excision between January 2013 and August 2013 were initially included in this study. Finally, 63 patients with 67 lesions classified as NML lesions comprised our study population. The features of SWE and its diagnostic performance in NML lesions were analyzed. Among the 67 NML lesions, 33 were malignant and 34 were benign. The maximum elastic modulus, mean elastic modulus, minimum elastic modulus, elastic modulus ratio and stiff rim sign of the malignant lesions were all significantly higher than those of benign lesions (p < 0.05). The combination of conventional US with maximum elastic modulus and stiff rim sign got significantly higher diagnostic specificity and positive predictive value (PPV) than conventional US (p < 0.05 for both). In the benign lesions, 23 (67.6%) unnecessary biopsies could have been eliminated after the combination of conventional US and SWE. SWE could increase diagnostic specificity and positive predictive values of NML breast lesions. The combination of conventional US and SWE could reduce unnecessary benign biopsies of NML lesions.     

超声与磁共振融合虚拟导航技术在乳腺病变定位中的初步研究

目的探讨超声融合磁共振成像（MRI）虚拟导航技术对仅MRI发现的乳腺病变定位的临床价值。 方法选取2016年6月至2018年12月于浙江大学医学院附属杭州市第一人民医院就诊的21例患者,均行超声及乳腺MRI检查,MRI发现22个超声上未显示的病灶且乳腺影像报告与数据系统（BI-RADS）评估为4类及以上,在俯卧位下行超声与MRI融合虚拟导航下定位,分别对病灶进行穿刺活检或定位后手术切除,与病理结果相对照,以及MRI术前/后对比,统计病变检出率,并分析此类病变的MRI特征及病理类型。 结果22个病灶中共计20个在虚拟导航下完成定位,检出率为91%。术后病理显示18个（90%）为良性病变,2个（10%）为恶性病变。22个病变中,MRI显示20个（91%）为非肿块样强化,仅2个（9%）为肿块型强化。 结论超声融合MRI虚拟导航可以有效提高超声隐匿性乳腺病变的检出率,通过超声引导下穿刺活检具有实时、便捷等特点,可在临床推广应用。     

人工智能辅助BI-RADS分类指导乳腺肿物活检的初步研究

目的探讨人工智能(S-Detect技术)辅助BI-RADS分类指导乳腺肿物活检的价值。方法常规超声BI-RADS分类均为4类的51例患者,共52个病灶均进行穿刺活检。穿刺活检前行S-Detect辅助结节的BI-RADS再次分类,以病理结果作为金标准比较两种分类方法的差异。结果BI-RADS 4类结节遵照指南均应进行穿刺活检,活检率100%(52/52)、阳性预测值38.5%(20/52)、假阳性率61.5%(32/52)、漏诊率0%(0/20)。S-Detect辅助分类后,52个病灶中24个降类为3类,则活检率53.8%(28/52)、阳性预测值67.9%(19/28)、假阳性率32.1%(9/28)、漏诊率5%(1/20)均发生明显变化,其中活检率及假阳性率显著减低(P<0.01),漏诊率的变化无统计学意义(P>0.05)。结论S-Detect辅助乳腺结节再次分类有助于减少不必要的穿刺活检,提高活检效能。     

Reproducible Surveillance Breast Ultrasound Using an Image Fusion Technique in a Short-Interval Follow-up for BI-RADS 3 Lesions: A Pilot Study

The aim of our study was to verify the utility of surveillance ultrasound (US) using real-time virtual sonography (RVS) - to coordinate present US images with past US images reconstructed from previously acquired US volume data using an image fusion technique - for short-interval follow-up of Breast Imaging-Reporting and Data System (BI-RADS) category 3 mass lesions. We enrolled 20 women (23 lesions) with more than 24 mo of follow-up after classification as BI-RADS category 3 during initial US. US surveillance was scheduled at 6, 12 and 24 mo. Measurement of the target lesion diameter was performed after the probe was adjusted to include the maximum diameter of a past US image at each visit. RVS was technically successful in 100% of patients. All target lesions were detected, including two iso-echoic lesions. The mean target lesion diameters at baseline and at 6, 12 and 24 mo were 8.2 ± 4.2, 8.4 ± 4.5, 8.1 ± 4.5 and 8.3 ± 5.0 mm, respectively (p = 0.785). Our results suggest that RVS is a reproducible, operator-independent technique for comparison of US images of BI-RADS category 3 mass lesions obtained at different time points.     

数字化乳腺X线摄影检出BI-RADS 3~5级微钙化病变的动态增强MR研究

目的探讨DCE-MRI对数字化乳腺X线摄影检出BI-RADS3-5级微钙化病变的诊断价值。方法44例数字化乳腺X线摄影发现BI-RADS3-5级微钙化的患者于活检前完成双乳DCE-MR检查,以术后病理诊断为金标准,分析BI-RADS3～5级微钙化病变的DCE-MRI特点。结果病理证实良性微钙化病变13例,恶性微钙化病变31例。38.46%(5/13)良性单纯微钙化病变在DCE-MRI上无强化,93.33%(14/15)恶性微钙化伴肿块或局限性致密影病变在DCE-MRI上有明显强化,良恶性微钙化病变在DCE-MRI上早期增强率之间差异有显著统计学意义。DCE-MRI对微钙化病变诊断的敏感性和特异性分别为96.77%和92.31%。结论良恶性微钙化病变的DCE-MRI表现有明显差异,DCE-MRI有助于微钙化病变的定性诊断。     

Phyllodes Tumors of the Breast: Ultrasonographic Findings and Diagnostic Performance of Ultrasound-Guided Core Needle Biopsy

We evaluated ultrasonography (US) findings between benign and malignant phyllodes tumors and analyzed diagnostic performance of US-guided core needle biopsy (CNB) for phyllodes tumors. Surgically removed phyllodes tumors of 168 women were divided into two groups according to the benign and malignant (including borderline tumor) groups and 116 were benign and 52 were malignant. On US, the complex cystic echogenicity (p = 0.021), presence of cleft (p = 0.005) and higher final US assessment (p = 0.008) were more frequent in the malignant group. The sensitivity of CNB including fibroepithelial tumors was 67.9% (114/168) and the concordant rate between CNB and surgical excision was 82.1% (32/39) and 5.8% (3/52) in the benign and malignant group. Our results suggested that the US findings of complex cystic echogenicity, cleft, higher final US assessment were more frequent in malignant phyllodes tumors. The sensitivity of CNB was 67.9% (114/168) and malignant phyllodes tumors were rarely diagnosed as malignant by US-guided CNB.     

Development of a gel-simulation model and generation of standard tables for the complete extirpation of benign breast lesions with vacuum assisted biopsy under ultrasound guidance

In combination with high-resolution ultrasound (US), vacuum-assisted biopsy (VB) techniques can be used for accurate diagnosis confirmation and therapeutic minimally invasive removal of benign breast lesions. We developed a gel-simulation model to imitate the removal of benign breast lesions (e.g., fibroadenoma) with VB from a turkey breast-phantom. Bilobular US-sensitive models in the form of a fibroadenoma were manufactured from flexible, cuttable synthetic material (longitudinal diameters of 4-20 mm). They were implanted in turkey meat and vacuum biopsied under 2-D and 3-D imaging with 11G and 8 G needles. The minimum number of cylinders removed per tumour volume, the maximum complete excision tumour size and the optimum needle gauge were determined. Lesions with a longitudinal diameter of up to 10 to 12 mm could be removed with the 11G needle, those up to 20 mm with the 8G needle. The values for the correct needle size, number of cylinders per tumour size to be removed produced with the gel turkey phantoms provide a reference for clinicians performing VB with total excision intent. VB is suitable for the removal of benign lesions with a diameter of up to 20 mm.     

Minimal invasive complete excision of benign breast tumors using a three-dimensional ultrasound-guided mammotome vacuum device.

OBJECTIVE: The aim of this study was to evaluate the use of three-dimensional (3D) ultrasonography in the complete excision of benign breast tumors using ultrasound-guided vacuum-assisted core-needle biopsy (Mammotome). A protocol for the management of benign breast tumors is proposed. METHOD: Twenty consecutive patients with sonographically benign breast lesions underwent 3D ultrasound-guided mammotome biopsy under local anesthesia. The indication for surgical biopsy was a solid lesion with benign characteristics on both two-dimensional (2D) and 3D ultrasound imaging, increasing in size over time or causing pain or irritation. Preoperatively, the size of the lesion was assessed using 2D and 3D volumetry. During vacuum biopsy the needle was visualized sonographically in all three dimensions, including the coronal plane. Excisional biopsy was considered complete when no residual tumor tissue could be seen sonographically. Ultrasonographic follow-up examinations were performed on the following day and 3-6 months later to assess residual tissue and scarring. RESULTS: All lesions were histologically benign. Follow-up examinations revealed complete excision of all lesions of < 1.5 mL in volume as assessed by 3D volumetry. 3D ultrasonographic volume assessment was more accurate than 2D using the ellipsoid formula or assessment of the maximum diameter for the prediction of complete excision of the tumor. No bleeding or infections occurred postoperatively and no scarring was seen ultrasonographically on follow-up examinations. CONCLUSIONS: Ultrasound-guided vacuum-assisted biopsy allows complete excision of benign breast lesions that are 相似文献   

Subcategorization of ultrasonographic BI-RADS category 4: positive predictive value and clinical factors affecting it

The objective of this study was to evaluate the positive predictive value (PPV) in ultrasonographically (US)-detected breast lesions of BI-RADS category 4a, 4b and 4c and to find how various clinical factors influenced the PPV of category 4. A total of 2142 women with 2430 breast lesions diagnosed on US as BI-RADS category 4 and underwent biopsy were included. Among them, 452 (18.6%) were pathologically confirmed as malignancy. PPV of each US BI-RADS subcategory was 7.6% (149/1963) for category 4a, 37.8% (68/180) for category 4b and 81.9% (235/287) for category 4c. Several clinical factors were more significantly seen in malignancy of category 4a and 4b, whereas none of the factors showed significance in category 4c. Subcategorization of category 4 is a feasible method in predicting malignancy in which patients’ age, lack of multiplicity and symptoms affected the PPV of category 4 lesions. (E-mail: ekkim@yuhs.ac)     

Prospective evaluation of the value of combined mammographic and sonographic assessment in patients with palpable abnormalities of the breast.

OBJECTIVE: To evaluate the role of combined mammographic and sonographic imaging in patients with palpable abnormalities of the breast. METHODS: Four hundred eleven consecutive cases of palpable abnormalities of the breast underwent combined mammographic and sonographic evaluation. Patients who did not undergo biopsy had imaging and clinical follow-up; the mean follow-up period was 28.9 months (range, 24-33 months). RESULTS: One hundred sixty-five (40.1%) of 411 palpable abnormalities had a benign assessment; 97 (58.7%) of the 165 benign lesions were visible on both mammography and sonography; 66 (40%) of 165 benign lesions were mammographically occult and identified at sonographic evaluation. In 60 (14.6%) of the 411 cases, imaging evaluation resulted in a suspicious assessment; 49 (81.7%) of the 60 lesions categorized as suspicious underwent biopsy; 14 (28.5%) of 49 lesions were histologically proved to be carcinoma. Nineteen (31.6%) of the 60 lesions categorized as suspicious were mammographically occult and identified only on sonography; 14 (73.7%) of these 19 lesions underwent biopsy; 12 (63.1%) of 19 were benign, and 2 (10.5%) were malignant. One hundred eighty-six (45.2%) of the 411 palpable abnormalities had negative imaging assessment findings; 12 patients with negative imaging findings underwent biopsy, and all had benign findings. The sensitivity (14 of 14) and negative predictive value (186 of 186) for a combined mammographic and sonographic assessment were 100%; the specificity was 80.1% (186 of 232). CONCLUSIONS: Cancer was diagnosed in 14 (3.4%) of 411 women who underwent combined imaging for palpable abnormalities of the breast. Combined mammographic and sonographic assessment was shown to be very helpful in identifying benign as well as malignant lesions causing palpable abnormalities of the breast.     

超声引导下穿刺活检在乳腺非肿块样病变诊断中的应用价值

目的探讨超声引导下穿刺活检在乳腺非肿块样病变中的诊断价值。 方法选取2017年1月至2018年12月杭州市第一人民医院超声科经超声检查评估为乳腺影像报告与数据系统（BI-RADS）4a类及以上的乳腺非肿块样病变患者93例,共计93个病灶。所有病变均行超声引导下穿刺活检,并经手术病理证实。应用四格表计算超声引导下穿刺活检对乳腺非肿块样病变的诊断效能。 结果手术病理结果提示,恶性病灶47个,良性病灶46个。超声引导下穿刺活检结果提示恶性病灶43个,良性50个。穿刺活检漏诊4个恶性病灶,术前超声均提示为BI-RADS 4b,术后病理证实3例为导管原位癌和1例为浸润癌。超声引导下穿刺活检诊断乳腺非肿块样病变的敏感度为91.4%（43/47）,特异度为100.0%（46/46）,假阴性率为8.6%（4/47）,诊断准确性为95.7%（89/93）。 结论超声引导下穿刺活检对乳腺非肿块样病变的诊断存在一定的假阴性率,但敏感度、特异度及准确性均较高,具有良好的诊断价值。     

MRI导引下真空辅助乳腺病灶旋切活检技术的临床应用

目的 探讨MRI导引下真空辅助旋切乳腺病灶活检技术的可行性。方法 对45例患者共45个乳腺可疑病灶行MRI导引下真空辅助旋切活检。观察其技术成功率和术后并发症情况,并进行随访。结果 在45个乳腺可疑病灶中,经MRI导引下真空辅助旋切活检43个（43/45,95.56%）病灶成功取样并获取病理学诊断,2个（2/45,4.44%）病灶未获取病理学诊断。穿刺操作用时（45.87±8.41）min。5个（5/45,11.11%）活检病理为恶性的病灶,均与术后病理结果相符;38个（38/45,84.44%）活检病理为良性的病灶,6个月后MRI随访均未见恶性表现。根据活检病理结果指导14例（14/45,31.11%）患者调整了治疗方案,其中5例（5/45,11.11%）恶性肿瘤患者得以早期确诊,9例（9/45,20.00%）疑似恶性的良性肿瘤患者避免了外科手术。45例患者活检术后均无感染及血肿等并发症发生。结论 MRI导引下真空辅助旋切乳腺病灶活检安全、有效地完成乳腺可疑病灶取样,对乳腺可疑病灶患者的临床治疗方案具有指导作用。     

Malignant Lesions Initially Categorized as Probably Benign Breast Lesions: Retrospective Review of Ultrasonographic,Clinical and Pathologic Characteristics

The primary objective of this study was to review the ultrasonographic features of BI-RADS category 3 (“probably benign”) lesions that eventually proved to be malignant. A second objective was to investigate their clinical and pathologic features according to their palpability and time of biopsy. Thirty-two (0.8%) of 4000 women with lesions that were initially classified as “probably benign” proved to be malignant and formed the study group. The most common reason for a false negative assessment on ultrasound was a failure to recognize suspicious margin characteristics (28 of 32 malignancies, 87.5%). Malignancy was more frequent in palpable (2.4%, 21 of 859) than nonpalpable lesions (0.4%, 11 of 3141, p < 0.001). There was no statistical difference in the mean age, mean size of lesions, or tumor stage between patients who underwent early biopsy (n = 19) or biopsy after 6 months (n = 13). Twenty-nine of the lesions (90.6%) were retrospectively recategorized as BI-RADS 4, which calls for early biopsy. BI-RADS 3 lesions require especially careful assessment. (E-mail: ekkim@yuhs.ac)     

Comparison of Strain and Shear Wave Elastography for the Differentiation of Benign From Malignant Breast Lesions,Combined With B-mode Ultrasonography: Qualitative and Quantitative Assessments

Our aim was to compare the diagnostic performance of strain elastography (SE) and shear-wave elastography (SWE), combined with B-mode ultrasonography (US), in breast cancer. For 79 breast lesions that underwent SE and SWE, two radiologists reviewed five data sets (B-mode US, SWE, SE and two combined sets). Qualitative and quantitative elastographic data and Breast Imaging Reporting and Data System (BI-RADS) categories were recorded. The area under the receiver operating characteristic curve (AUC) was evaluated. No significant difference in the AUC between the two elastography methods was noted. After subjective assessment by reviewers, the AUC for the combined sets was improved (SWE, 0.987; SE, 0.982; B-mode US, 0.970; p < 0.05). When SE and SWE were added, 38% and 56% of benign BI-RADS category 4a lesions with a low suspicion of cancer were downgraded without false-negative results, respectively. SE and SWE performed similarly. Therefore, addition of SE or SWE improved the diagnostic performance of B-mode US, potentially reducing unnecessary biopsies.     

MRI在BI-RADS4类乳腺疾病中的应用价值

目的探讨MR成像在乳腺x线摄影BI-RADS 4类乳腺病变中的应用价值。方法 107例乳腺x线摄影评估为BI-RADS 4类的乳腺疾病入选本研究,分为MRI和活检两组,与病理或临床随访结果相比较,并以Fisher精确检验比较两组管理方案间的差异。结果 48例MRI组中,31例乳腺病变BI-RADS评级维持4类或评级上升(≥4类),手术病理示乳腺癌29例,良性2例;17例病变评级下降(≤3类),其中3例选择手术治疗,病理结果为乳腺纤维腺瘤1例和乳腺腺病伴钙盐沉积2例,余14例随访1年以上病灶未见明显变化,MRI准确率为95.83%。59例活检组中,真阳性18例,假阴性7例,真阴性34例,准确性为88.14%,MRI组和活检组两者对乳腺癌诊断差异无统计学意义(x~2=2.036;P=0.154)。结论乳腺MR成像对X线摄影评估为BI-RADS 4类的病变具有细分和参考价值,可提高早期乳腺癌的检出率,减少不必要的手术及活检,并对良性病变提供更多的影像学支持。     

Factors affecting the efficacy of ultrasound-guided vacuum-assisted percutaneous excision for removal of benign breast lesions.

OBJECTIVE: This study was designed to evaluate the effectiveness of complete removal and factors affecting the presence of a residual mass and complications after ultrasound-guided vacuum-assisted percutaneous removal of benign breast lesions. METHODS: We retrospectively evaluated ultrasound images and medical records of 263 breast masses from 199 patients that were removed with an ultrasound-guided vacuum-assisted device. All lesions were assumed as benign on ultrasound imaging or had been confirmed as benign by a previous core needle biopsy. The influence of the size, distance from the nipple, number of lesions removed at a time, and pathologic diagnosis of all of the removed masses on the completeness of the removal and the presence of complications was analyzed. The Mann-Whitney U test was used in the statistical analysis. RESULTS: The complete removal rate for ultrasound imaging immediately after the procedure was 95.8%, and the rate at more than 6 months for follow-up ultrasound imaging was 92.3%. Larger lesions, lesions closer to the nipple, and cases in which multiple lesions were removed at a time showed the presence of more residual lesions. Lesions closer to the nipple and cases in which multiple lesions were removed simultaneously developed more hematomas (P < .05). CONCLUSIONS: Ultrasound-guided vacuum-assisted percutaneous excision showed high effectiveness for the removal of benign breast masses. However, more attention should be given to certain lesions to increase the efficacy.     

Mimickers of Breast Malignancy on Breast Sonography

The aim of this article is to review benign breast lesions that can mimic carcinoma on sonography. Cases of benign lesions mimicking carcinoma on sonography were collected among lesions that were initially assessed as suspicious on sonography according to the American College of Radiology Breast Imaging Reporting and Data System category. Sonographically guided core needle biopsy was performed, and the pathologic types were confirmed to be benign. Cases of benign lesions mimicking carcinoma on sonography were shown to include fat necrosis, diabetic mastopathy, fibrocystic changes, sclerosing adenosis, ruptured inflammatory cysts, inflammatory abscesses, granulomatous mastitis, fibroadenomas, fibroadenomatous mastopathy, and apocrine metaplasia. Benign breast lesions may present with malignant features on imaging. A clear understanding of the range of appearances of benign breast lesions that mimic malignancy is important in radiologic‐pathologic correlation to ensure that benign results are accepted when concordant with imaging and clinical features but, when discordant, there is no delay in further evaluation up to and including excisional biopsy.     

B-Mode Ultrasound Combined with Color Doppler and Strain Elastography in the Diagnosis of Non-mass Breast Lesions: A Prospective Study

Non-mass breast lesions on ultrasound (US) are areas without an associated mass. The purpose of this study was to evaluate whether combining B-mode US with color Doppler US and strain elastography (SE) improves US differentiation between benign and malignant non-mass breast lesions and the decision for biopsy. In this prospective study, three different radiologists analyzed the US images of 77 non-mass lesions independently and recorded Breast Imaging Reporting and Data System (BI-RADS) categories for four data sets. The image characteristics and BI-RADS categories of the four data sets were analyzed by another radiologist. The final diagnosis was made on the basis of pathologic findings. Values for area under the receiver operating curve (AUC), sensitivity, specificity and accuracy were compared among the data sets. The AUC of B-mode US combined with both color Doppler US and SE was greater than that of B-mode US alone (0.666 vs. 0.828) (p = 0.011). The specificity of making the decision for biopsy increased from 6.5% to 38.7% when B-mode US was combined with color Doppler and SE, without a statistically significant change in sensitivity (p < 0.001). Combined use of color Doppler and SE could improve the diagnostic value of B-mode US in distinguishing benign from malignant non-mass breast lesions and the specificity of making the decision for biopsy of non-mass breast lesions.     

乳腺良性结节超声BI-RADS分级的可靠性及其影响因素分析

目的 研究超声诊断乳腺良性结节(BI-RADS 3级)的可靠性,分析影响乳腺肿块BI-RADS分级的可能因素及其程度.方法 对792例参照BI-RADS超声影像学特征描述初步分级为可能良性的乳腺结节(BI RADS 3级)、并且有明确病理结果或有2年以上随访记录的患者,回顾性分析超声诊断乳腺良性结节的可靠性;并且结合已由文献推荐的新的分级标准重新对研究对象超声图像进行判读,探讨可能影响其BI-RADS超声分级的多个因素(患者年龄、病灶大小、病灶数目、体表触诊、医师经验).结果 792例病例中,781例(98.6%)为良性,11例(1.4%)为恶性.重新判读后:35.1%(278/792)的病例被调升至BI-RADS 4级,恶性肿瘤的检出率为81.8%(9/11);低年资组判断的良性结节较高年资组者易被调升至4级(P<0.05);年龄≥40岁或多发病灶的患者乳腺结节被调至4级的可能性大(P<0.01);乳腺病灶能否触及、病灶大小则对BI-RADS分级无明显影响.结论 超声对乳腺良性结节(BI-RADS 3级)的判断可靠性较高,医师经验、乳腺结节是否多发以及患者年龄对超声判断良性病灶有影响.

Abstract：

Objective To evaluate the reliability of benign nodules diagnosed by ultrasound and analyze the probable factors of infecting the BI-RADS ultrasound categorization of breast lesions. Methods A total of 792 cases with initial category 3 assessments on BI-RADS ultrasound categorization consistent with more than 2 years follow-up or pathologic results were contained. The reliability of probable benign lesions were studied retrospectively,and several factors that could influence the categorization were explored such as age,breast lumps size,multiplicity,palpability,and US radiologist's experience referring to ACR-BI-RADS and the new categorizations recommendation. Results Of 792 breast nodules, 781 (98.6%) were benign and 11 (1.4%) were malignant. If the new categorizations recommendation was applied, 35. 1% (278/792) of all cased would have been upgraded to BI-RADS 4,81. 8% (9/11)of malignant tumors would have been found. The breast masses diagnosed by the junior radiologists were more frequently upgraded to BI-RADS 4 than senior radiologists' findings (P <0. 05), the nodules in women 40 years or older and multiple lesions were more frequently upgraded to category 4 (P <0. 01). The presence of palpability and mass size had on significantly influence the BI-RADS US categorization of breast nodules. Conclusions BI-RADS-Ultrasound categorization is relatively reliable to diagnose breast benign nodules. The multiplicity of breast nodules,patient's age and US radiologist's experience were found to have significant influences on the categorizations of probably benign breast nodules.