Phantom-based analysis of variations in automatic exposure control across three mammography systems: implications for radiation dose and image quality in mammography, DBT, and CEM.

BACKGROUND: Automatic exposure control (AEC) plays a crucial role in mammography by determining the exposure conditions needed to achieve specific image quality based on the absorption characteristics of compressed breasts. This study aimed to characterize the behavior of AEC for digital mammography (DM), digital breast tomosynthesis (DBT), and low-energy (LE) and high-energy (HE) acquisitions used in contrast-enhanced mammography (CEM) for three mammography systems from two manufacturers. METHODS: Using phantoms simulating various breast thicknesses, 363 studies were acquired using all available AEC modes 165 DM, 132 DBT, and 66 LE-CEM and HE-CEM. AEC behaviors were compared across systems and modalities to assess the impact of different technical components and manufacturers' strategies on the resulting mean glandular doses (MGDs) and image quality metrics such as contrast-to-noise ratio (CNR). RESULTS: For all systems and modalities, AEC increased MGD for increasing phantom thicknesses and decreased CNR. The median MGD values (interquartile ranges) were 1.135 mGy (0.772-1.668) for DM, 1.257 mGy (0.971-1.863) for DBT, 1.280 mGy (0.937-1.878) for LE-CEM, and 0.630 mGy (0.397-0.713) for HE-CEM. Medians CNRs were 14.2 (7.8-20.2) for DM, 4.91 (2.58-7.20) for a single projection in DBT, 11.9 (8.0-18.2) for LE-CEM, and 5.2 (3.6-9.2) for HE-CEM. AECs showed high repeatability, with variations lower than 5% for all modes in DM, DBT, and CEM. CONCLUSIONS: The study revealed substantial differences in AEC behavior between systems, modalities, and AEC modes, influenced by technical components and manufacturers' strategies, with potential implications in radiation dose and image quality in clinical settings. RELEVANCE STATEMENT: The study emphasized the central role of automatic exposure control in DM, DBT, and CEM acquisitions and the great variability in dose and image quality among manufacturers and between modalities. Caution is needed when generalizing conclusions about differences across mammography modalities. KEY POINTS: • AEC plays a crucial role in DM, DBT, and CEM. • AEC determines the "optimal" exposure conditions needed to achieve specific image quality. • The study revealed substantial differences in AEC behavior, influenced by differences in technical components and strategies.

The risk-based breast screening (RIBBS) study protocol: a personalized screening model for young women.

The optimal mammography screening strategy for women aged 45-49 years is a matter of debate. We present the RIBBS study protocol, a quasi-experimental, prospective, population-based study comparing a risk- and breast density-stratified screening model (interventional cohort) with annual digital mammography (DM) screening (observational control cohort) in a real-world setting. The interventional cohort consists of 10,269 women aged 45 years enrolled between 2020 and 2021 from two provinces of the Veneto Region (northen Italy). At baseline, participants underwent two-view digital breast tomosynthesis (DBT) and completed the Tyrer-Cuzick risk prediction model. Volumetric breast density (VBD) was calculated from DBT and the lifetime risk (LTR) was estimated by including VBD among the risk factors. Based on VBD and LTR, women were classified into five subgroups with specific screening protocols for subsequent screening rounds: (1) LTR ≤ 17% and nondense breast: biennial DBT; (2) LTR ≤ 17% and dense breast: biennial DBT and ultrasound; (3) LTR 17-30% or LTR > 30% without family history of BC, and nondense breast: annual DBT; (4) LTR 17-30% or > 30% without family history of BC, and dense breast: annual DBT and ultrasound; and (5) LTR > 30% and family history of BC: annual DBT and breast MRI. The interventional cohort is still ongoing. An observational, nonequivalent control cohort of 43,000 women aged 45 years participating in an annual DM screening programme was recruited in three provinces of the neighbouring Emilia-Romagna Region. Cumulative incidence rates of advanced BC at three, five, and ten years between the two cohorts will be compared, adjusting for the incidence difference at baseline.Trial registration This study is registered on Clinicaltrials.gov (NCT05675085).

Using automated software evaluation to improve the performance of breast radiographers in tomosynthesis screening.

OBJECTIVE: To improve breast radiographers' individual performance by using automated software to assess the correctness of breast positioning and compression in tomosynthesis screening. MATERIALS AND METHODS: In this retrospective longitudinal analysis of prospective cohorts, six breast radiographers with varying experience in the field were asked to use automated software to improve their performance in breast compression and positioning. The software tool automatically analyzes craniocaudal (CC) and mediolateral oblique (MLO) views for their positioning quality by scoring them according to PGMI classifications (perfect, good, moderate, inadequate) and checking whether the compression pressure is within the target range. The positioning and compression data from the studies acquired before the start of the project were used as individual baselines, while the data obtained after the training were used to test whether conscious use of the software could help the radiographers improve their performance. The percentage of views rated perfect or good and the percentage of views in target compression were used as overall metrics to assess changes in performance. RESULTS: Following the use of the software, all radiographers significantly increased the percentage of images rated as perfect or good in both CCs and MLOs. Individual improvements ranged from 7 to 14% for CC and 10 to 16% for MLO views. Moreover, most radiographers exhibited improved compression performance in CCs, with improvements up to 16%. CONCLUSION: Active use of a software tool to automatically assess the correctness of breast compression and positioning in breast cancer screening can improve the performance of radiographers. CLINICAL RELEVANCE STATEMENT: This study suggests that the use of a software tool for automatically evaluating correctness of breast compression and positioning in breast cancer screening can improve the performance of radiographers on these metrics, which may ultimately lead to improved screening outcomes. KEY POINTS: • Proper breast positioning and compression are critical in breast cancer screening to ensure accurate diagnosis. • Active use of the software increased the quality of craniocaudal and mediolateral oblique views acquired by all radiographers. • Improved performance of radiographers is expected to improve screening outcomes.

The Impact of COVID-19 on Treatment Practices for Patients With Early Breast Cancer: A Cross-Sectional Study From a Large Cancer Center in Italy.

INTRODUCTION: The Coronavirus Disease 2019 (COVID-19) has disrupted health services worldwide. The evidence on the impact of the pandemic on cancer care provision, however, is conflicting. We aimed to audit the management of patients diagnosed with early breast cancer (EBC) during the pandemic in a large, tertiary-level cancer center in Italy. METHODS: We conducted a cross-sectional study to track the route to first treatment for patients diagnosed with EBC during 2019, 2020, and 2021. We abstracted data for all consecutive patients referred to the Veneto Institute of Oncology (Padua, Italy). We defined as point of contact (POC) the date of the first consultation with a breast cancer specialist of the breast unit. First treatment was defined as either upfront surgery or neoadjuvant chemotherapy (NACT). RESULTS: We reviewed medical records for 878 patients for whom an MDT report during 2019-2021 (April through June) was available. Of these, 431 (49%) were eligible. The proportion of screen-detected tumors was larger in 2019 and 2021 than in 2020 (59%). Conversely, the proportion of screen-detected tumors was offset by the proportion of palpable tumors in 2020 (P = .004). Distribution of tumor and nodal stage was unchanged over time, but in situ tumors were slightly fewer in 2020 than in 2019 or 2021. The adjusted odds ratio for treatment delay (45 days or more) was 0.87 for 2020 versus 2019 (95% CI, 0.5-1.53) and 0.9 for 2021 versus 2019 (95% CI, 0.52-1.55). CONCLUSIONS: There was no evidence for major changes in the management of patients with EBC during 2019-2021 and no treatment delays were observed. Our findings suggest that more women presented with palpable nodules at diagnosis, but the stage distribution did not change over time. Validation on a larger cohort of patients is warranted to robustly assess the impact of the COVID-19 pandemic on treatment practices for patients with EBC.

Presence and Role of Associations of Cancer Patients and Volunteers in Specialist Breast Centres: An Italian National Survey of Breast Centres Associated with Senonetwork.

This article aims to present the results of a national, cross-sectional, voluntary, online survey on the presence and roles of associations of breast cancer patients and volunteers in Italian specialist breast centres. The survey was developed according to standard methods. The questionnaire was pre-tested by a random sample of three breast centres, loaded onto the SurveyMonkey platform, and piloted by one volunteer breast centre. The breast centre clinical leads were invited to participate via email. A link to the online instrument was provided. No financial incentives were offered. The results were reported using standard descriptive statistics. The response rate was 82/128 (65%). Members of associations were routinely present in 70% Italian breast centres. Breast centres most often reporting their presence were those certified by the European Society of Breast Cancer Specialists. Patient support (reception and information, listening, identification of needs, and psychological support) was the primary area where associations were reported to offer services. The magnitude of this phenomenon warrants a study to investigate the impact of the activities of associations on the quality of life of patients and on the cost-benefit ratio of the service, and the modes of their interactions with the nursing staff and the medical staff.

Radiological response of leptomeningeal metastases according to revised RANO criteria is associated with overall survival in breast cancer patients.

Assessment of treatment response in patients (pts) with leptomeningeal metastases (LM) represents a significant challenge and standardized criteria are needed. In 2017, the RANO LM Working Group proposed a standardized scorecard to evaluate MRI findings (further simplified in 2019). Here, we aim to validate the prognostic impact of response to treatment assessed using this tool in a multicentric cohort of breast cancer (BC) pts. Pts with BC-related LM diagnosed at two institutions between 2005 and 2018 were identified. Baseline and follow-up MRI scans were centrally reviewed and response assessment was evaluated using 2019 revised RANO LM criteria. A total of 142 pts with BC-related LM and available baseline brain MRI imaging were identified; 60 of them had at least one follow-up MRI. In this subgroup, median overall survival (OS) was 15.2 months (95%CI 9.5-21.0). At first re-evaluation, radiological response by RANO criteria was: complete response (CR) in 2 pts (3%), partial response (PR) in 12 (20%), stable disease (SD) in 33 (55%) and progression of disease (PD) in 13 (22%). Median OS was 31.1 months (HR 0.10, 95%CI 0.01-0.78) in pts with CR, 16.1 months (HR 0.41, 95%CI 0.17-0.97) in pts with PR, 17.9 months (HR 0.45, 95%CI 0.22-0.91) in pts with SD and 9.5 months in pts with PD (P = .029). A second blinded evaluation showed a moderate interobserver agreement (K = 0.562). Radiological response according to 2019 RANO criteria is significantly associated with OS in pts with BC-related LM, thus supporting the use of this evaluation tool both in trials and clinical practice.

Secondary prevention and treatment innovation of early stage non-small cell lung cancer: Impact on diagnostic-therapeutic pathway from a multidisciplinary perspective.

Lung cancer (LC) is the leading cause of cancer-related death worldwide, mostly because the lack of a screening program so far. Although smoking cessation has a central role in LC primary prevention, several trials on LC screening through low-dose computed tomography (LDCT) in a high risk population showed a significant reduction of LC related mortality. Most trials showed heterogeneity in terms of selection criteria, comparator arm, detection nodule method, timing and intervals of screening and duration of the follow-up. LC screening programs currently active in Europe as well as around the world will lead to a higher number of early-stage Non Small Cell Lung Cancer (NSCLC) at the diagnosis. Innovative drugs have been recently transposed from the metastatic to the perioperative setting, leading to improvements in terms of resection rates and pathological responses after induction chemoimmunotherapy, and disease free survival with targeted agents and immune checkpoint inhibitors. The present review summarizes available evidence about LC screening, highlighting potential pitfalls and benefits and underlining the impact on the diagnostic therapeutic pathway of NSCLC from a multidisciplinary perspective. Future perspectives in terms of circulating biomarkers under evaluation for patients' risk stratification as well as a focus on recent clinical trials results and ongoing studies in the perioperative setting will be also presented.

The Multidisciplinary Approach in Stage III Non-Small Cell Lung Cancer over Ten Years: From Radiation Therapy Optimisation to Innovative Systemic Treatments.

Background: About 30% of new non-small cell lung cancer (NSCLC) cases are diagnosed at a locally advanced stage, which includes a highly heterogeneous group of patients with a wide spectrum of treatment options. The management of stage III NSCLC involves a multidisciplinary team, adequate staging, and a careful patient selection for surgery or radiation therapy integrated with systemic treatment. Methods: This is a single-center observational retrospective and prospective study including a consecutive series of stage III NSCLC patients who were referred to the Veneto Institute of Oncology and University Hospital of Padova (Italy) between 2012 and 2021. We described clinico-pathological characteristics, therapeutic pathways, and treatment responses in terms of radiological response in the entire study population and in terms of pathological response in patients who underwent surgery after induction therapy. Furthermore, we analysed survival outcomes in terms of relapse-free survival (RFS) and overall survival (OS). Results: A total of 301 patients were included. The majority of patients received surgical multimodality treatment (n = 223, 74.1%), while the remaining patients (n = 78, 25.9%) underwent definitive CRT followed or not by durvalumab as consolidation therapy. At data cut-off, 188 patients (62.5%) relapsed and the median RFS (mRFS) of the entire population was 18.2 months (95% CI: 15.83−20.57). At the time of analyses 140 patients (46.5%) were alive and the median OS (mOS) was 44.7 months (95% CI: 38.4−51.0). A statistically significant difference both in mRFS (p = 0.002) and in mOS (p < 0.001) was observed according to the therapeutic pathway in the entire population, and selecting patients treated after 2018, a significant difference in mRFS (p = 0.006) and mOS (p < 0.001) was observed according to treatment modality. Furthermore, considering only patients diagnosed with stage IIIB-C (N = 131, 43.5%), there were significant differences both in mRFS (p = 0.047) and in mOS (p = 0.022) as per the treatment algorithm. The mRFS of the unresectable population was 16.3 months (95% CI: 11.48−21.12), with a significant difference among subgroups (p = 0.030) in favour of patients who underwent the PACIFIC-regimen; while the mOS was 46.5 months (95% CI: 26.46−66.65), with a significant difference between two subgroups (p = 0.003) in favour of consolidation immunotherapy. Conclusions: Our work provides insights into the management and the survival outcomes of stage III NSCLC over about 10 years. We found that the choice of radical treatment impacts on outcome, thus suggesting the importance of appropriate staging at diagnosis, patient selection, and of the multidisciplinary approach in the decision-making process. Our results confirmed that the PACIFIC trial and the following introduction of durvalumab as consolidation treatment may be considered as a turning point for several improvements in the diagnostic-therapeutic pathway of stage III NSCLC patients.

Integrating mammography screening programmes into specialist breast centres in Italy: insights from a national survey of Senonetwork breast centres.

BACKGROUND: Despite recommendations, mammography screening is often insufficiently integrated into specialist breast centres. A national, cross-sectional, voluntary, online survey on this issue was carried out among the Italian breast centres associated with Senonetwork, the Italian network of breast cancer services. METHODS: A 73-item questionnaire was created, pre-tested and piloted. Centres integrating and not integrating a screening programme were compared using the unified theory of acceptance and use of technology (UTAUT) model. Centres' clustering was performed using the Gower's distance metric. Groups and clusters were compared with the equality-of-means test. RESULTS: The response rate was 82/128 (65%). Overall, 84% (69/82) breast centres reported a collaboration with a screening programme in performing and/or reading mammograms and in the diagnostic work-up of women with abnormal screening results. The same proportion was observed among those centres responding to all questions (62/74). Performance expectancies (or the perceived usefulness of integration in terms of clinical quality, patient convenience, ease of job, and professional growth), satisfaction and motivation were higher in those centres collaborating with the screening programme. Effort expectancy indicators (or the degree to which the respondents believe that the integration is easy to implement) and those concerning the existence of facilitating conditions were lower both in centres collaborating and not collaborating with the screening programme. Among the former, six clusters of centres, distributed from 'no integration' to 'high', were identified. In cluster analysis, the highest level of integration was associated with higher agreement that integration eases the job, offers better opportunities for professional growth, and makes the working environment more satisfactory. The least integrated cluster assigned the lowest score to the statement that local health authority made available the resources needed. CONCLUSIONS: While confirming the positive effects of integrating screening programmes into breast centres, this survey has brought to light specific difficulties that must be faced. The results provide insights into the importance of integration focusing on the perspectives of professional career and motivation. The deficiency of facilitating conditions to integration is modifiable. Screening professionals' societies may have a role as initiators of the integration. Other supporting actions may be included in health laws at the national and regional level.

Artifact reduction in contrast-enhanced mammography.

OBJECTIVE: To evaluate the effectiveness of a new algorithm developed to reduce artifacts in dual-energy subtraction (DES) contrast-enhanced mammography (CEM) images while preserving contrast enhancement of possible lesions. METHODS: A retrospective multi-reader paired study was performed by using 134 CEM studies obtained from the first 134 women enrolled in a prospective clinical study aiming to compare the clinical performance of CEM to those of breast MRI in screening of women at increased risk of breast cancer. Four experienced readers compared independently the standard (STD) DES images with those obtained by reprocessing the raw images by a new algorithm (NEW), expected to reduce the DES artifact intensity. The intensity of three types of artifacts (breast-in-breast, ripple, and skinfold enhancement) and the intensity of possible contrast uptake were assessed visually and rated using a categorical ordinal scale. Proportions of images rated by the majority of readers as "Absent", "Weak", "Medium", "Strong" in each artifact intensity category were compared between the two algorithms. P-values lower than 0.05 were considered statistically significant. RESULTS: The NEW algorithm succeeded in eliminating 84.5% of breast-in-breast artifacts, 84.2% of ripple artifacts, and 56.9% of skinfold enhancement artifacts versus STD DES images, and reduced the artifact intensity in 12.1%, 13.0%, and 28.8% of the images, respectively. The visibility of lesion contrast uptake was the same with the STD and the NEW algorithms. CONCLUSION: The new dual-energy subtraction algorithm demonstrated to be effective in reducing/eliminating CEM-related artifacts while preserving lesion contrast enhancement.

Radiation Dose of Contrast-Enhanced Mammography: A Two-Center Prospective Comparison.

The radiation dose associated with contrast-enhanced mammography (CEM) has been investigated only by single-center studies. In this retrospective study, we aimed to compare the radiation dose between two centers performing CEM within two prospective studies, using the same type of equipment. The CEM mean glandular dose (MGD) was computed for low energy (LE) and high energy (HE) images and their sum was calculated for each view. MGD and related parameters (entrance dose, breast thickness, compression, and density) were compared between the two centers using the Mann−Whitney test. Finally, per-patient MGD was calculated by pooling the two datasets and determining the contribution of LE and HE images. A total of 348 CEM examinations were analyzed (228 from Center 1 and 120 from Center 2). The median total MGD per view was 2.33 mGy (interquartile range 2.19−2.51 mGy) at Center 1 and 2.46 mGy (interquartile range 2.32−2.70 mGy) at Center 2, with a 0.15 mGy median difference (p < 0.001) equal to 6.2%. LE-images contributed between 64% and 77% to the total patient dose in CEM, with the remaining 23−36% being associated with HE images. The mean radiation dose for a two-view bilateral CEM exam was 4.90 mGy, about 30% higher than for digital mammography.

Structured reporting of x-ray mammography in the first diagnosis of breast cancer: a Delphi consensus proposal.

BACKGROUND: Radiology is an essential tool in the management of a patient. The aim of this manuscript was to build structured report (SR) Mammography based in Breast Cancer. METHODS: A working team of 16 experts (group A) was composed to create a SR for Mammography Breast Cancer. A further working group of 4 experts (group B), blinded to the activities of the group A, was composed to assess the quality and clinical usefulness of the SR final draft. Modified Delphi process was used to assess level of agreement for all report sections. Cronbach's alpha (Cα) correlation coefficient was used to assess internal consistency and to measure quality analysis according to the average inter-item correlation. RESULTS: The final SR version was built by including n = 2 items in Personal Data, n = 4 items in Setting, n = 2 items in Comparison with previous breast examination, n = 19 items in Anamnesis and clinical context; n = 10 items in Technique; n = 1 item in Radiation dose; n = 5 items Parenchymal pattern; n = 28 items in Description of the finding; n = 12 items in Diagnostic categories and Report and n = 1 item in Conclusions. The overall mean score of the experts and the sum of score for structured report were 4.9 and 807 in the second round. The Cronbach's alpha (Cα) correlation coefficient was 0.82 in the second round. About the quality evaluation, the overall mean score of the experts was 3.3. The Cronbach's alpha (Cα) correlation coefficient was 0.90. CONCLUSIONS: Structured reporting improves the quality, clarity and reproducibility of reports across departments, cities, countries and internationally and will assist patient management and improve breast health care and facilitate research.

Provision of follow-up care for women with a history of breast cancer following the 2016 position paper by the Italian Group for Mammographic Screening and the Italian College of Breast Radiologists by SIRM: a survey of Senonetwork Italian breast centres.

INTRODUCTION: In 2016, the Italian Group for Mammography Screening and the Italian College of Breast Radiologists by the Italian Society of Medical and Interventional Radiology recommended that screening programmes and specialist breast centres actively invite women with a history of breast cancer to follow-up imaging. OBJECTIVE: A survey of breast centres associated with Senonetwork, the Italian network of breast cancer services, has offered the opportunity to assess the implementation of this recommendation. METHODS: A national, cross-sectional, voluntary, online survey was developed, pre-tested, and administered during the months July-October 2020. Five of the 73 questionnaire items concerned breast cancer follow-up. RESULTS: The response rate was 82/128 (65%). Of the 82 respondent centres, 69 (84%) were involved in a screening programme. Fifty-six (68%) reported the presence of a programme of active invitation to breast cancer follow-up targeted at patients living in their catchment area, with a significant north-to-south gradient. Four centres (5%) reported that the screening programme was responsible for actively initiating follow-up during the 10-year period since diagnosis. Only after 10 years did the proportion increase moderately. CONCLUSION: Screening programmes have still a marginal role in active breast cancer follow-up.

Quantitative Breast Density in Contrast-Enhanced Mammography.

Contrast-enhanced mammography (CEM) demonstrates a potential role in personalized screening models, in particular for women at increased risk and women with dense breasts. In this study, volumetric breast density (VBD) measured in CEM images was compared with VBD obtained from digital mammography (DM) or tomosynthesis (DBT) images. A total of 150 women who underwent CEM between March 2019 and December 2020, having at least a DM/DBT study performed before/after CEM, were included. Low-energy CEM (LE-CEM) and DM/DBT images were processed with automatic software to obtain the VBD. VBDs from the paired datasets were compared by Wilcoxon tests. A multivariate regression model was applied to analyze the relationship between VBD differences and multiple independent variables certainly or potentially affecting VBD. Median VBD was comparable for LE-CEM and DM/DBT (12.73% vs. 12.39%), not evidencing any statistically significant difference (p = 0.5855). VBD differences between LE-CEM and DM were associated with significant differences of glandular volume, breast thickness, compression force and pressure, contact area, and nipple-to-posterior-edge distance, i.e., variables reflecting differences in breast positioning (coefficient of determination 0.6023; multiple correlation coefficient 0.7761). Volumetric breast density was obtained from low-energy contrast-enhanced spectral mammography and was not significantly different from volumetric breast density measured from standard mammograms.

3T DCE-MRI Radiomics Improves Predictive Models of Complete Response to Neoadjuvant Chemotherapy in Breast Cancer.

OBJECTIVES: To test whether 3T MRI radiomics of breast malignant lesions improves the performance of predictive models of complete response to neoadjuvant chemotherapy when added to other clinical, histological and radiological information. METHODS: Women who consecutively had pre-neoadjuvant chemotherapy (NAC) 3T DCE-MRI between January 2016 and October 2019 were retrospectively included in the study. 18F-FDG PET-CT and histological information obtained through lesion biopsy were also available. All patients underwent surgery and specimens were analyzed. Subjects were divided between complete responders (Pinder class 1i or 1ii) and non-complete responders to NAC. Geometric, first order or textural (higher order) radiomic features were extracted from pre-NAC MRI and feature reduction was performed. Five radiomic features were added to other available information to build predictive models of complete response to NAC using three different classifiers (logistic regression, support vector machines regression and random forest) and exploring the whole set of possible feature selections. RESULTS: The study population consisted of 20 complete responders and 40 non-complete responders. Models including MRI radiomic features consistently showed better performance compared to combinations of other clinical, histological and radiological information. The AUC (ROC analysis) of predictors that did not include radiomic features reached up to 0.89, while all three classifiers gave AUC higher than 0.90 with the inclusion of radiomic information (range: 0.91-0.98). CONCLUSIONS: Radiomic features extracted from 3T DCE-MRI consistently improved predictive models of complete response to neo-adjuvant chemotherapy. However, further investigation is necessary before this information can be used for clinical decision making.

Preoperative non-palpable breast lesion localization, innovative techniques and clinical outcomes in surgical practice: A systematic review and meta-analysis.

Pre-operative localization of non-palpable breast lesions with non-wired non-ionizing (NWNI) techniques may improve clinical outcomes as reoperation rate, cosmetic outcome and contribute to organizational aspects improvement in breast-conserving surgery (BCS). However only limited literature is available and clinical studies involving these forefront devices are often small and non-randomized. Furthermore, there is a lack of consensus on free margins and cosmetic outcomes definitions. The objective of the present meta-analysis was to determine the crude clinical outcomes reported for the NWNI techniques on BCS. A literature search was performed of PubMed, Embase and Scopus databases up to February 2021 in order to select all prospective or retrospective clinical trials on pre-operative breast lesion localization done with NWNI devices. All studies were assessed following the PRISMA recommendations. Continuous outcomes were described in averages corrected for sample size, while binomial outcomes were described using the weighted average proportion. Twenty-seven studies with a total of 2103 procedures were identified. The technique is consolidated, showing for both reflectors' positioning and localization nearly the 100% rate of success. The re-excision and clear margins rates were 14% (95% CI, 11-17%) and 87% (80-92%), respectively. Overall, positive margins rates were 12% (8-17%). In studies that compared NWNI and wire localization techniques, positive margin rate is lower for the first techniques (12%, 6-22% vs 17%, 12-23%) and re-excision rate is slightly higher using the latter (13%, 9-19% vs 16%, 13-18%). Pre-operative NWNI techniques are effective in the localization of non-palpable breast lesions and are promising in obtaining clear (or negative) margins minimizing the need for re-excision and improving the cosmetic outcomes. Randomized trials are needed to confirm these findings.

Repeat Screening Outcomes with Digital Breast Tomosynthesis Plus Synthetic Mammography for Breast Cancer Detection: Results from the Prospective Verona Pilot Study.

Background Few results are available about subsequent outcomes after screening with digital breast tomosynthesis (DBT). Purpose To compare the diagnostic accuracy of a screening round with DBT plus synthetic mammography (SM) (hereafter, DBT+SM) and the repeat screening round with DBT with SM (hereafter, DBT+SM) or full-field digital mammography (FFDM) with FFDM screening. Materials and Methods This prospective study (Verona Pilot Study, clinical trial identification: 2015/1238) included women screened with DBT+SM between April 2015 and March 2017 and rescreened with DBT+SM or FFDM between April 2017 and March 2019. Screening performance (recall rate, cancer detection rate [CDR], and positive predictive value of recall [PPV1]) was compared with that obtained from 28 680 women screened with FFDM between 2013 and 2014 (control group). Cancer stages were compared between modalities and screening rounds. A χ2 test was used to evaluate differences. P < .05 was indicative of a statistically significant difference. Results Of 34 638 women enrolled, 32 870 (median age, 58 years; age range, 52-71 years) underwent repeat screening-16 198 with DBT+SM and 16 672 with FFDM. The CDR was higher for repeat screening with DBT+SM than for the control group with FFDM (8.1 per 1000 women screened vs 4.5 per 1000 women screened, respectively; P < .01) and was not significantly lower for repeat screening with FFDM (3.5 per 1000 women screened vs 4.5 per 1000 women screened, respectively; P = .11). Compared with the control group, there was no difference in the recall rate at repeat screening with both DBT+SM (3.71% vs 3.40%, respectively; P = .10) and FFDM (3.71% vs 3.69%, P = .92), whereas PPV1 was higher only when repeat screening was performed with DBT+SM (23.8% vs 12.0%, P < .01). At repeat screening, the proportion of cancers stage II or higher was 14.5% (19 of 131 cancers) with DBT+SM and 8.5% (five of 59 cancers) with FFDM, both of which were lower than the proportion in the control group with FFDM (30 of 110 cancers, 27.3%) (P ≤ .01). Conclusion At repeat screening, digital breast tomosynthesis plus synthetic mammography depicted more cancers than full-field digital mammography (FFDM) and found a lower number of stage II cancers compared with FFDM. © RSNA, 2020 See also the editorial by Bae in this issue.

Lesions of uncertain malignant potential of the breast (B3) on vacuum-assisted biopsy for microcalcifications: Predictors of malignancy.

PURPOSE: To investigate clinical, radiologic and pathologic features of B3 lesions diagnosed on VABB targeting microcalcifications, for identifying predictors of malignancy. METHOD: This retrospective multi-centre study included consecutive VABBs performed over a 10-year period on suspicious microcalcifications not associated with other radiological signs diagnosed as B3 on histology from VABB, with outcomes ascertained by surgical excision. Clinical, demographic, radiological and histological (B3 subcategory) data were collected. For statistical analysis (univariate and binary logistic regression), the primary outcome variable was the upgrade rate to malignancy after surgery. Predictors of upgrade to malignancy were identified from clinical, demographic, radiological and pathological variables (including B3 subcategory). RESULTS: Amongst 447 VABBs, there were 57(12.7 %) upgrades to malignancy at surgical histology (36 DCIS and 21 invasive cancer). At univariate analysis, variables significantly associated with increased risk of upgrade to malignancy were age>55 years (p = 0.01), lesion size>10 mm (p < 0.0001), BI-RADS 4b-c and 5 (p = 0.0001), and fine pleomorphic morphology (p = 0.002) of microcalcifications. Binary logistic regression confirmed as significant independent risk factors age, lesion size and BI-RADS category (p = 0.02, 0.02 and 0.0006 respectively). Amongst subcategories of B3 lesions, lobular neoplasia was significantly(p = 0.04) associated with upgrade, confirmed as an independent risk factor [p = 0.03, OR = 2.3(1.1-4.7)]. Flat epithelial atypia was significantly(p = 0.004) associated with reduced odds of upgrade, but binary logistic regression showed only borderline association [p = 0.052, OR = 0.4(0.2-1.01)]. CONCLUSIONS: Across B3 lesions diagnosed on histology from VABB of suspicious microcalcifications, older age, size>10 mm, BI-RADS category≥ 4b on imaging, and lobular neoplasia were risk factors for upgrade to malignancy. This information can be used to discuss patients' tailored management options.