Breast Cancer Screening and Diagnosis: A Synopsis of the European Breast Guidelines.

Description: The European Commission Initiative for Breast Cancer Screening and Diagnosis guidelines (European Breast Guidelines) are coordinated by the European Commission's Joint Research Centre. The target audience for the guidelines includes women, health professionals, and policymakers. Methods: An international guideline panel of 28 multidisciplinary members, including patients, developed questions and corresponding recommendations that were informed by systematic reviews of the evidence conducted between March 2016 and December 2018. GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests by enhancing transparency. Questions and recommendations, expressed as strong or conditional, focused on outcomes that matter to women and provided a rating of the certainty of evidence. Recommendations: This synopsis of the European Breast Guidelines provides recommendations regarding organized screening programs for women aged 40 to 75 years who are at average risk. The recommendations address digital mammography screening and the addition of hand-held ultrasonography, automated breast ultrasonography, or magnetic resonance imaging compared with mammography alone. The recommendations also discuss the frequency of screening and inform decision making for women at average risk who are recalled for suspicious lesions or who have high breast density.

A phased approach to implementing the Breast Imaging Reporting and Data System (BI-RADS) in low-income and middle-income countries.

BACKGROUND: Successful breast cancer detection programs rely on standardized reporting and interpreting systems, such as the Breast Imaging Reporting and Data System (BI-RADS), to improve system performance. In low-income and middle-income countries, evolving diagnostic programs have insufficient resources to either fully implement BI-RADS or to periodically evaluate the program's performance, which is a necessary component of BI-RADS. This leads to inconsistent breast ultrasound interpretation and a failure to improve performance. METHODS: The authors applied the Breast Health Global Initiative's phased implementation strategy to implement diagnostic ultrasound and BI-RADS within the context of a limited-resource setting. RESULTS: The authors recommended starting with triage ultrasound to distinguish suspicious masses from normal breast tissue and benign masses such as cysts because the majority of health workers performing ultrasounds at this level have minimal breast imaging experience. Transitioning to full diagnostic ultrasound with condensed or full BI-RADS should occur after performance and quality metrics have been met. CONCLUSIONS: Transitioning through these phases across facilities likely will occur at different times, particularly in rural versus urban settings.

Diagnosis of sub-centimetre breast lesions: combining BI-RADS-US with strain elastography and contrast-enhanced ultrasound-a preliminary study in China.

OBJECTIVES: To compare the diagnostic efficacies of B-mode ultrasound (US), strain elastography (SE), contrast-enhanced ultrasound (CEUS) and the combination of these modalities for breast lesions <1 cm in size. METHODS: Between January 2013 and October 2015, 203 inpatients with 209 sub-centimetre breast lesions categorised as BI-RADS-US (Breast Imaging Reporting and Data System for Ultrasound) 3-5 were included. US, SE and CEUS were performed to evaluate each lesion. The diagnostic performances of different ultrasonic modalities were compared. The diagnostic efficacies of BI-RADS-US and our re-rating systems were also compared. The pathology findings were used as the reference standard. RESULTS: The specificities of US, SE and CEUS for tumour differentiation were 17.4 %, 56.2 % and 86.0 %, respectively (P < 0.05); and the sensitivities were 100 %, 93.2 % and 93.2 % for US, SE and CEUS, respectively (P < 0.05). The area under the curve (AUC) of the receiver operating characteristic (ROC) curve was 0.867 for original BI-RADS-US, 0.882 for BI-RADS-US combined with only SE, 0.953 for BI-RADS-US combined with only CEUS and 0.924 for BI-RADS-US combined with both SE and CEUS. The best combination was BI-RADS-US combined with only CEUS. CONCLUSIONS: Evaluating sub-centimetre breast lesions with SE and CEUS could increase the diagnostic specificity while retaining high sensitivity compared with B-mode ultrasound. KEY POINTS: • Evaluating breast lesions with SE and CEUS could increase the diagnostic specificity • SE and CEUS offer alternatives to biopsy and possibly allow shorter-interval follow-ups • BI-RADS-US combined with CEUS exhibited the best diagnostic performance.

Elastography Complements Ultrasound as Principle Modality in Breast Lesion Assessment.

BACKGROUND: The study aimed to improve breast cancer diagnosis with new ultrasound (US) modalities. We examined whether real-time elastography (RTE) complements the diagnostic performance of US. METHODS: The Ethical Committee approved the study. Patients provided written informed consent and received a whole breast workup. Breast lesions were evaluated by US and RTE. Lesions were assessed by BI-RADS, Tsukuba score (TS) and strain ratio (SR). RESULTS: The study included 164 breast lesions of which 101 were benign and 63 malignant. Women with benign lesions were predominantly premenopausal with sonographic dense breast tissue. Women with breast cancer were mostly postmenopausal, with a low sonographic density. Benign lesions had a mean TS of 2.05, which was significantly lower than the mean TS of 3.25 for malignant lesions. The SR for benign lesions (SR 1.83) was significantly smaller than for breast cancer (SR 4.83). Sensitivity and specificity was 95 and 81% for BI-RADS, 39 and 94% for TS, and 57 and 83% for SR, with a cutoff at 2.5. The combination of BI-RADS, TS and SR yielded a sensitivity of 95% and a specificity of 85%. CONCLUSION: Besides morphologic features revealed by US, elastic properties of breast lesions obtained by RTE can be exploited for diagnostic breast imaging.

Inter-rater reliability and double reading analysis of an automated three-dimensional breast ultrasound system: comparison of two independent examiners.

PURPOSE: Breast ultrasound could be a valuable tool complementary to mammography in breast cancer screening. Automated 3D breast ultrasound (ABUS) addresses challenges of hand-held ultrasound and could allow double reading analysis of ultrasound images. This trial assesses the inter-rater reliability and double reading analysis of an ABUS system. METHODS: To assess the reproducibility and diagnostic validity of the ABUS system, SomoV™, a blinded double reading analysis, was performed in 1019 patients (2038 breasts) by two examiners (examiner A/B) and compared to single reading results, as well as to the reference standard regarding its diagnostic validity. Cohen's kappa coefficients were calculated to measure the inter-rater reliability and agreement of the different diagnostic modalities. Patient comfort and time consumption for image acquisition and reading were analyzed descriptively as secondary objectives. RESULTS: Analysis of inter-rater reliability yielded agreement in 81.6% (κ = 0.37; p < 0.0001) showing fair agreement. Single reading analysis of SomoV™ exams (examiner A/examiner B) compared to reference standard showed good specificity (examiner A: 88.3%/examiner B: 84.5%), fair inter-rater agreement (examiner A: κ = 0.31/examiner B: κ = 0.31), and adequate sensitivity (examiner A: 53.1%/examiner B: 64.2%). Double reading analysis yielded good sensitivity and specificity (73.7 and 77.7%). Mammography (n = 1911) alone detected 160 of 176 carcinomas (sensitivity 90.1%). Adding SomoV™ to mammography would have detected 12 additional carcinomas, resulting in a higher sensitivity of 97.7%. CONCLUSION: SomoV™ is a promising technique with good sensitivity, high patient comfort, and fair inter-examiner reliability. It allows double reading analysis that, in combination with mammography, could increase detection rates in breast cancer screening.

Study on female breast cancer imaging screening consultation network in Guangdong Province, China.

OBJECTIVE: This study aimed to construct breast cancer image screening consultation network (BISCN) that connects all levels of medical institutions in Guangdong Province. MATERIALS AND METHODS: Fourteen hospitals in different cities and counties (districts) of Guang-dong were selected for breast cancer screening with imaging (breast X-ray, ultrasound, and MRI). "Breast Imaging Reporting and Data System (BI-RADS)" was taken as reference to build up image data base of breast cancer screening and BISCN that is an internet-based network platform. BISCN quality control was performed to improve the diagnostic accuracy and collaboration of members. In 2011, the BISCN members underwent breast imaging diagnosis training and conducted a questionnaire survey. RESULTS: BISCN allowed quick, synchronous, and accurate communication and feedback of diagnostic imaging in breast cancer among all levels of medical institutions and improved the ability of breast cancer screening in the province, as well as the detection rate of early breast cancer throughout the province, especially in the grassroot units. The survey results showed that the trainees' understanding situation of the training contents before training was 2.02 ± 1.75 points. Through the study, the participants considered that the teaching contents could solve the daily diagnose problems (2.91 ± 0.70 points), the post-training scores were improved (2.88 ± 1.23 points), and highly satisfactory with the teaching contents (2.81 ± 0.53 points). All students passed the examination and were qualified for the future. CONCLUSIONS: BISCN is of good feasibility in construction and applicability in management by raising diagnosis level of breast cancer in Guangdong Province.

Training and standards for performance, interpretation, and structured reporting for supplemental breast cancer screening.

OBJECTIVE. To compensate for the reduction of mammography's sensitivity in women with dense breasts, supplemental screening can increase the cancer detection rate. The modalities suggested are MRI, which is the most sensitive and is indicated for women with the highest risk of breast cancer, and ultrasound, which is suggested for dense-breasted average-risk women. CONCLUSION. For decades, ultrasound has been a focused examination. Extending a handheld ultrasound examination to depict the entire breast requires formal didactic training and hands-on scanning to learn suitable, efficient methods. Automated options also require intensive training in performance and interpretation.

Technologist-performed handheld screening breast US imaging: how is it performed and what are the outcomes to date?

Breast density-inform legislation is increasing the need for data on outcomes of tailored screening. Dense parenchyma can mask cancers, and denser tissue is also more likely to develop breast cancer than fatty tissue. Digital mammography is standard for women with dense breasts. Supplemental screening magnetic resonance imaging should be offered to women who meet high-risk criteria. Supplemental screening ultrasonographic (US) imaging may be appropriate in the much larger group of women with dense breasts. Both physician- and technologist-performed screening US imaging increases detection of node-negative invasive breast cancer. To meet anticipated demand in the United States, screening US images will most likely be acquired by trained technologists rather than physicians. While automated US offers standard documentation, there are few data on outcomes. US has been used diagnostically for decades to characterize masses seen by using mammography, but training specific to screening has been lacking. Standard approaches to training and documentation of technologist-performed handheld screening US imaging are needed. This article reviews the current status of technologist-performed handheld screening breast US imaging.

Dense breasts: a review of reporting legislation and available supplemental screening options.

OBJECTIVE: The objectives of this article are to discuss the Mammography Quality Standards Act (MQSA) and what it means for patients, define breast density and explain how it is measured, review the new state-based legislation regarding the reporting of dense breast tissue directly to patients and the possibility of an adjunct screening examination, describe possible supplemental screening options and the advantages and disadvantages of each, and outline the current shortcomings and unanswered questions regarding new legislation. CONCLUSION: Breast density is now established as an independent risk factor for developing breast cancer irrespective of other known risk factors. Women with breast density in the upper quartile have an associated four to five times greater risk of developing breast cancer relative to women with breast density in the lower quartile. Many states have enacted or proposed legislation requiring mammographers to report to patients directly if they have dense breast tissue and recommend discussing the possibility of a supplemental screening examination with their physicians. However, there is currently no consensus as to whether a supplemental screening examination should be pursued or which modality to use. Possible supplemental screening modalities include ultrasound, MRI, digital breast tomosynthesis, and molecular breast imaging. The U.S. Food and Drug Administration recently approved an automated breast ultrasound system for screening whole-breast ultrasound in patients with dense breasts. However, many questions are still unanswered including the impact on morbidity and mortality, cost-effectiveness, and insurance coverage.

Bayesian probability of malignancy with BI-RADS sonographic features.

OBJECTIVES: The purpose of this study was to develop a quantitative approach for combining individual American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) sonographic features of breast masses for assessing the overall probability of malignancy. METHODS: Sonograms of solid breast masses were analyzed by 2 observers blinded to patient age, mammographic features, and lesion pathologic findings. BI-RADS sonographic features were determined by using American College of Radiology criteria. A naïve Bayes model was used to determine the probability of malignancy of all the sonographic features together and with age and BI-RADS mammographic features. The diagnostic performance for various combinations was evaluated by using the area under the receiver operating curve (Az). RESULTS: Sonographic features had high positive and negative predictive values. The Az values for BI-RADS sonographic features for the 2 observers ranged from 0.772 to 0.884, which increased to 0.866 to 0.924 when used with patient age and BI-RADS mammographic features. The benefit of adding age and mammographic information was more marked for the observer with lower initial diagnostic performance. Age-specific analysis showed that diagnostic performance varied with age, with higher performance for patients aged 45 years and younger and patients older than 60 years compared to those aged 46 to 60 years. In 85% of cases, the diagnosis of the observers matched. When the consensus between the observers was used for diagnostic decisions, a high level of diagnostic performance (Az, 0.954) was achieved. CONCLUSIONS: A naïve Bayes model provides a systematic approach for combining sonographic features and other patient characteristics for assessing the probability of malignancy to differentiate malignant and benign breast masses.

Determining the impact of US mammography screening guidelines on patient survival in a predominantly African American population treated in a public hospital during 2008.

BACKGROUND: In November 2009, the US Preventive Service Task Force (USPSTF) published updated breast cancer screening guidelines. This marked a change from the 2002 recommendations and a significant divergence from the American Cancer Society (ACS) guidelines. In the current study, the potential effect of using the revised 2009 USPSTF guidelines on patient disease stage and survival were evaluated and compared with those actually observed and to predicted under ACS recommendations. METHODS: A retrospective chart review was performed for 84 patients who were diagnosed with stage I through III breast cancer at Grady Memorial Hospital during 2008. Previously published tumor volume doubling times were used to model an equation that would estimate tumor sizes. For each patient, a disease stage at diagnosis was predicted, and outcomes were modeled as though the patient had been screened according to the recommended versions of the ACS and USPSTF guidelines. Patient survival rates were then estimated based on prognostic data according to disease stage. RESULTS: The average age of patients in the study was 55 years, and 85% were African American. The USPSTF guidelines predicted later stages at diagnosis (14% stage I, 73% stage II), whereas the ACS guidelines predicted earlier stages (47% stage I, 53% stage II). CONCLUSIONS: A large stage migration was predicted, indicating significantly earlier diagnosis, when the ACS-recommended screening guidelines were followed. The authors concluded that practitioners should understand how race and/or socioeconomic factors increase the risk of breast cancer and should be encouraged to prioritize discussions regarding the benefits and risks of annual mammographic screening, especially among women who have a potentially greater risk of developing breast cancer at a younger age.

In vivo measurement of breast skin elasticity and breast skin thickness.

BACKGROUND: The mechanical properties of the breast skin play an important role in explaining the changes associated with radiotherapy, tissue expansion, and breast reconstruction surgery. Quantitative measurement of mechanical properties of breast skin is essential for surgical preplanning and outcome prediction. We have measured the skin elasticity properties and skin thickness of the breast using noninvasive methods. METHODS: The DermaLab suction cup and the DermaScanC ultrasound were used to measure the modulus of elasticity and the skin thickness, respectively. Measurements were taken in 16 different locations on the breast in 23 female patients, also with patients in supine and upright position. Different analytical models (plate, membrane, large deformation) that can represent the experiment were studied to extract the elasticity modulus. RESULTS: The average modulus of breast skin elasticity found was 344 ± 88 kPa (Mean ± SD) with 95% confidence interval being 306-382 kPa. The range of the modulus was 195-480 kPa. The average thickness of breast skin was 1.55 ± 0.25 mm with a range of 0.83-2.4 mm. CONCLUSIONS: Regional variations of breast skin elasticity properties and breast skin thickness were observed. No direct correlations of biomechanical properties with age or breast thickness were observed. No significant difference was observed in the elasticity modulus between the supine and upright patient positions.

Breast vibro-acoustography: initial results show promise.

INTRODUCTION: Vibro-acoustography (VA) is a recently developed imaging modality that is sensitive to the dynamic characteristics of tissue. It detects low-frequency harmonic vibrations in tissue that are induced by the radiation force of ultrasound. Here, we have investigated applications of VA for in vivo breast imaging. METHODS: A recently developed combined mammography-VA system for in vivo breast imaging was tested on female volunteers, aged 25 years or older, with suspected breast lesions on their clinical examination. After mammography, a set of VA scans was acquired by the experimental device. In a masked assessment, VA images were evaluated independently by 3 reviewers who identified mass lesions and calcifications. The diagnostic accuracy of this imaging method was determined by comparing the reviewers' responses with clinical data. RESULTS: We collected images from 57 participants: 7 were used for training and 48 for evaluation of diagnostic accuracy (images from 2 participants were excluded because of unexpected imaging artifacts). In total, 16 malignant and 32 benign lesions were examined. Specificity for diagnostic accuracy was 94% or higher for all 3 reviewers, but sensitivity varied (69% to 100%). All reviewers were able to detect 97% of masses, but sensitivity for detection of calcification was lower (≤ 72% for all reviewers). CONCLUSIONS: VA can be used to detect various breast abnormalities, including calcifications and benign and malignant masses, with relatively high specificity. VA technology may lead to a new clinical tool for breast imaging applications.

The influence of technical factors on sonoelastographic assessment of solid breast nodules.

PURPOSE: The aim of the study was to assess the influence of technical factors and/or lesion characteristics on the final elastographic score in solid breast nodules. MATERIALS AND METHODS: Patients with solid breast masses examined between May 2007 and May 2008 in the Radiology Department of Cluj District University Hospital were included in the study. All lesions were examined with conventional ultrasound, Doppler ultrasound and sonoelastography, according to a preset protocol. The influence of the following factors on the elastographic score was evaluated: type of section (sagittal versus transverse); size of region of interest (small versus large); amplitude and frequency of movement; initial compression (light versus strong); angulation (perpendicular versus angulated transducer); characteristics of the lesion (size and location). The reference diagnosis was the histopathology diagnosis and, in twenty cases, short-term follow-up. RESULTS: Ninety-two patients with a mean age of 48.11 years and 101 breast nodules were included in the study. The overall sensitivity and specificity for elastography were 79 % [68-88 %] and 79 % [65 - 89 %], respectively, with a negative predictive value of 74 % [60-85 %] and a positive predictive value of 84 % [72-91 %]. The following factors did not influence the elastographic score: type of section (scores on transverse and longitudinal section, Z = -0.641, p = 0.552); the amplitude and frequency of movements during the elastographic examination (Cochran's Q concordance = 0.706, p = 0.872); strong initial compression in the case of benign nodules (Z = 0.000, p = 1.000); size of the lesions. Of the elastographically benign nodules, 9 were false negative and of the 46 elastographically malignant nodules, 12 were false positive. The following factors influenced the elastographic scores: size of the region of interest (the scores were significantly different when small or large region of interest was used, Z = -0.671, p < 0.0001); transducer angulation (Z = -5.42, p < 0.0001); strong initial compression in the case of malignant nodules (Z = -6.044, p < 0.0001) and the location of the mass in the vicinity of the chest wall. CONCLUSION: The most important factors that influence the final elastographic score, leading to false negative results, are the size of the region of interest, the initial compression and angulation of the transducer, while the frequency and amplitude of movement during the examination proved to be of no importance as long as the images were obtained within a range of assessment usefulness. Changing the scanning parameters never led to false positive results in the case of malignant breast masses.

Detecting accurate tumor size across imaging modalities in breast cancer.

BACKGROUND: Of the most common imaging modalities for breast cancer diagnosis - mammogram (MAM), ultrasound (US), magnetic resonance imaging (MRI) - it has not been well established which of these most accurately corresponds to the histological tumor size. OBJECTIVE: To determine which imaging modality (MAM, US, MRI) is most accurate for determining the histological tumor size of breast lesions. METHODS: A retrospective study of 76 breast cancers found in 73 female patients who received MAM, US, and/or MRI was performed. 239 charts were reviewed and 73 patients met inclusion criteria. Analysis was performed using signed rank tests comparing the reported tumor size on the imaging modality to the tumor size on pathology report. RESULTS: Mammography and ultrasonography underestimated tumor size by 3.5 mm and 4 mm (p-values < 0.002), respectively. MRI tends to overestimate tumor size by 3 mm (p-value = 0.0570). Mammogram was equivalent to pathological size within 1 mm 24% of the time and within 2 mm 35% of the time. CONCLUSIONS: No one single modality is the most accurate for detecting tumor size. When interpreting the size reported on breast imaging modalities, the amount of underestimation and overestimation in tumor size should be considered for both clinical staging and surgical decision-making.

US of breast masses categorized as BI-RADS 3, 4, and 5: pictorial review of factors influencing clinical management.

The Breast Imaging Reporting and Data System (BI-RADS) lexicon for ultrasonography (US) is based on the established lexicon used successfully in mammography and attempts to provide a common language to avoid ambiguity in interpreting, reporting, and teaching breast US. Proper and consistent use of the BI-RADS US lexicon has numerous advantages, including facilitating (a) communication of final assessment categories that clearly indicate management recommendations, (b) data tracking for self-audits, and (c) clinical review of outcome summaries. However, the literature to date does not include sufficient data on outcomes to validate clinical use of the BI-RADS US lexicon. In this article, a pictorial review of the BI-RADS US lexicon descriptors is provided, and specific cases from a retrospective review are used to highlight the challenges in using the BI-RADS US lexicon. With these examples, suggestions are offered for greater clarity in the use of this lexicon. The technical challenges in follow-up US imaging are described. The challenges in assigning final assessment categories are detailed, as well as the clinical factors that may influence decision making and the management of certain lesions.

The correlation between ultrasonographic findings and pathologic features in breast disorders.

OBJECTIVE: Breast ultrasonography has gained widespread acceptance as a diagnostic tool for the evaluation of human breast disorders. It is important to evaluate the correlation of ultrasonography findings with the corresponding histopathological features. METHOD: We retrospectively reviewed the 154 cases of breast disorders. We evaluated the correlation the ultrasonography findings and carcinoma cells extension with their corresponding histopathological findings. In addition, we also studied the information on estimation of histological types and cancer extension used by the other modalities such as computed tomography and magnetic resonance imaging. RESULTS: The concordance rate for margins between ultrasonography findings and histopathological features was 91.6% (P < 0.001) and that for boundary zone was 87.0% (P < 0.001). Histopathological correlation of internal and posterior echoes demonstrated that internal low echo masses were composed of fibroblastic cells with marked collagenization in the stroma, or the cases in which carcinoma cells proliferated in a monotonous, solid and/or expanding manners. Attenuation of posterior echo was detected in the cases associated with hyperplasia of collagenized fibroblastic stroma. An increased cellularity in the mass with prominent large tumor nests and little fibrous stroma demonstrated the accentuation or no alterations of the posterior echo. The concordance rate of borders was 84.4% (P < 0.001). The correlation between estimated histological type by ultrasonography diagnosis and actual histological types was 87.0%. An overall detection rate of carcinoma extension by ultrasonography was 86.4%. In addition, an overall detection rate of carcinoma extension by ultrasonography, magnetic resonance imaging and computed tomography was 93.8%. CONCLUSION: These results demonstrated correlation between histopathological and ultrasonographic findings of the breast lesions is cardinal for quality control or improving the quality of ultrasonography.

A prospective study to compare the diagnostic performance of breast elastography versus conventional breast ultrasound.

AIM: To compare the diagnostic performance of breast elastography versus conventional ultrasound in the assessment of breast lesions. MATERIALS AND METHODS: The study was approved by the hospital's institutional review board. A prospective study involving 99 consecutive women who gave informed consent were enrolled from September 2007 to March 2008. One hundred and ten breast lesions were evaluated separately by conventional ultrasound, elastography and combined conventional ultrasound with elastography. Ultrasound assessment was based on the BIRADS classification, whereas elastographic assessment was based on strain pattern and the elastographic size ratios. Histological diagnosis was used as the reference standard. The sensitivity, specificity, and accuracy of each technique were compared. RESULTS: The mean age of the patients was 46.7 years. Twenty-six lesions were malignant and 84 were benign. Sensitivity, specificity, and accuracy were 88.5, 42.9 and 53.6%, respectively, for conventional ultrasound, 100, 73.8, and 80%, respectively, for elastography, and 88.5, 78.6, and 80.9%, respectively, for combined imaging. The specificity and accuracy of elastography and combined imaging were significantly better than that of conventional ultrasound (p<0.0001), whereas there was no statistically significant difference in the sensitivity between all three groups. Two-thirds (66.7%) of sonographic false-positive lesions had benign elastogram findings, which might have been spared from biopsy. CONCLUSION: This initial experience with ultrasound breast elastography showed that it was more specific and more accurate than conventional ultrasound. Combining elastography with ultrasound improved specificity and accuracy of ultrasound and can potentially reduce unnecessary breast biopsies.