ObjectiveContrast-enhanced spectral mammography (CESM) examination results in a low-energy (LE) and contrast-enhanced image. The LE appears similar to a full-field digital mammogram (FFDM). Our aim was to evaluate LE CESM image quality by comparing it to FFDM using criteria defined by the European Reference Organization for Quality Assured Breast Screening and Diagnostic Services (EUREF).MethodsA total of 147 cases with both FFDM and LE images were independently scored by two experienced radiologists using these (20) EUREF criteria. Contrast detail measurements were performed using a dedicated phantom. Differences in image quality scores, average glandular dose, and contrast detail measurements between LE and FFDM were tested for statistical significance.ResultsNo significant differences in image quality scores were observed between LE and FFDM images for 17 out of 20 criteria. LE scored significantly lower on one criterion regarding the sharpness of the pectoral muscle (p < 0.001), and significantly better on two criteria on the visualization of micro-calcifications (p = 0.02 and p = 0.034). Dose and contrast detail measurements did not reveal any physical explanation for these observed differences.ConclusionsLow-energy CESM images are non-inferior to FFDM images. From this perspective FFDM can be omitted in patients with an indication for CESM.Key Points• Low-energy CESM images are non-inferior to FFDM images.• Micro-calcifications are significantly more visible on LE CESM than on FFDM.• There is no physical explanation for this improved visibility of micro-calcifications.• There is no need for an extra FFDM when CESM is indicated.

ObjectivesContrast-enhanced spectral mammography (CESM) is a promising problem-solving tool in women referred from a breast cancer screening program. We aimed to study the validity of preliminary results of CESM using a larger panel of radiologists with different levels of CESM experience.MethodsAll women referred from the Dutch breast cancer screening program were eligible for CESM. 199 consecutive cases were viewed by ten radiologists. Four had extensive CESM experience, three had no CESM experience but were experienced breast radiologists, and three were residents. All readers provided a BI-RADS score for the low-energy CESM images first, after which the score could be adjusted when viewing the entire CESM exam. BI-RADS 1-3 were considered benign and BI-RADS 4-5 malignant. With this cutoff, we calculated sensitivity, specificity and area under the ROC curve.ResultsCESM increased diagnostic accuracy in all readers. The performance for all readers using CESM was: sensitivity 96.9 % (+3.9 %), specificity 69.7 % (+33.8 %) and area under the ROC curve 0.833 (+0.188).ConclusionCESM is superior to conventional mammography, with excellent problem-solving capabilities in women referred from the breast cancer screening program. Previous results were confirmed even in a larger panel of readers with varying CESM experience.Key Points• CESM is consistently superior to conventional mammography • CESM increases diagnostic accuracy regardless of a reader’s experience • CESM is an excellent problem-solving tool in recalls from screening programs

Background - Contrast-enhanced spectral mammography (CESM) is a promising new breast imaging modality that is superior to conventional mammography for breast cancer detection. We aimed to evaluate correlation and agreement of tumor size measurements using CESM. As additional analysis, we evaluated whether measurements using an additional breast MRI exam would yield more accurate results.Methods - Between January 1st 2013 and April 1st 2014, 87 consecutive breast cancer cases that underwent CESM were collected and data on maximum tumor size measurements were gathered. In 57 cases, tumor size measurements were also available for breast MRI. Histopathological results of the surgical specimen served as gold standard in all cases.Results - The Pearson's correlation coefficients (PCC) of CESM versus histopathology and breast MRI versus histopathology were all >0.9, p<0.0001. For the agreement between measurements, the mean difference between CESM and histopathology was 0.03 mm. The mean difference between breast MRI and histopathology was 2.12 mm. Using a 2x2 contingency table to assess the frequency distribution of a relevant size discrepancy of >1 cm between the two imaging modalities and histopathological results, we did not observe any advantage of performing an additional breast MRI after CESM in any of the cases.Conclusion - Quality of tumor size measurement using CESM is good and matches the quality of these measurement assessed by breast MRI. Additional measurements using breast MRI did not improve the quality of tumor size measurements.

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Background Detecting pathological breast calcifications remains challenging. Based on recent studies, contrast-enhanced spectral mammography (CESM) was shown to be superior compared to full-field digital mammography (FFDM). Purpose To evaluate the diagnostic accuracy of CESM in suspicious breast calcifications and its impact on surgical decision-making. Material and Methods All screening recalled patients with suspicious calcifications that underwent CESM in the period October 2012 until September 2015 were included. One experienced radiologist provided a BI-RADS classification for the FFDM images only. The evaluation was repeated for the CESM exam. In a simulated tumor board meeting, two breast surgeons decided on the preferred surgical treatment (breast conservation therapy [BCT] versus mastectomy) for all malignant cases. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated defining BI-RADS ≥4 as being malignant. In addition, differences in surgical decision-making were analyzed and compared using McNemar’s test. Results In total, 147 women were included in this study (mean age = 61 years; age range = 49–75 years). Pathology showed 82 benign and 65 malignant lesions, of which 33 were ductal carcinomas in situ and 32 were invasive lesions. Diagnostic performances of CESM (differences compared to FFDM in brackets) were: sensitivity 93.8% (+3%), specificity 36.6% (−2.5%), PPV 54% (0%), and NPV 88.2% (+4%). Based on low-energy images, surgeons suggested BCT in 89% of the cases. Based on the CESM exam, no statistical changes in decisions were observed (86% BCT, P = 0.453). Conclusion CESM only slightly improves the diagnostic accuracy of the evaluation of breast calcifications. It is not of added value compared to FFDM in guiding surgical decision-making.

BackgroundIn the Dutch breast cancer screening program, women recalled with a BI-RADS 0 score are referred for additional imaging, while those with BI-RADS 4/5 scores are also directed to an outpatient breast clinic. Approximately six out of ten women are recalled without being diagnosed with a malignancy. However, these recalls require additional imaging and doctor visits, which result in patient anxiety and increased health care costs. Conventional types of imaging used for additional imaging are full-field digital mammography and tomosynthesis. Contrast-enhanced spectral mammography has proved to have higher sensitivity and specificity than conventional imaging in women recalled from screening. Therefore, the aim is to study if CESM instead of conventional imaging is a more accurate, patient-friendly, and cost-effective strategy in the work-up of women recalled from breast cancer screening.MethodsThis prospective, multicenter, randomized controlled trial will be conducted at four centers and will include 528 patients recalled for suspicious breast lesions from the Dutch breast cancer screening program. Participants are randomized in two groups: (1) standard care using conventional breast imaging techniques as initial imaging after recall versus (2) work-up primarily based on CESM. Written informed consent will be collected prior to study inclusion. The primary outcome is the diagnostic accuracy for detection of breast cancer. Secondary outcomes are numbers of additional diagnostic exams, days until final diagnosis, health care costs, and experienced patient anxiety.DiscussionBased on previously published retrospective studies, we expect to demonstrate in this prospective multicenter randomized controlled trial, that using CESM as a primary work-up tool in women recalled from breast cancer screening is a more accurate, cost-effective, and patient-friendly strategy.Trial registration Netherlands Trial Register, NL6413/NTR6589. Registered on 6 July, 2017.

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