Time for Change in Digital Breast Tomosynthesis Research.

Background Multiple studies showed digital breast tomosynthesis (DBT) has a higher cancer detection rate and a lower recall rate than full-field digital mammography (FFDM). However, there is a paucity of studies on whether the benign biopsy rate will be lower with DBT. Purpose To evaluate the benign biopsy rate of DBT versus that of FFDM in women recalled after breast screening within the National Health Service Breast Screening Programme. Materials and Methods This prospective single institution study included women who underwent screening FFDM or screening breast MRI between November 13, 2015, and July 29, 2016, and were recalled. Women who were recalled underwent a breast examination, additional imaging (mammography, US), and biopsy, if required. The number of interventions and the outcome of assessment were recorded. FFDM was performed at the screening appointment, and DBT images were acquired when participants attended a screening assessment within 3 weeks after screening FFDM. Two of four readers blinded to biopsy results analyzed DBT images in isolation and then in conjunction with FFDM images and any additional two-dimensional mammographic or US images. Two-tailed McNemar tests were used to test differences in sensitivity and specificity of the two conditions at 5% significance level. Results During the study period, 30 933 women underwent FFDM. A total of 1470 women were recalled (recall rate, 4.8%), and 827 were included after exclusion criteria were applied. Their mean age was 56.7 years ± 7.7 (standard deviation). A total of 145 breast cancers were detected (142 with FFDM, two with DBT only, one with surveillance MRI). Triple assessment without DBT resulted in 571 breast biopsies and enabled detection of 142 cancers. The addition of DBT would have resulted in 298 biopsies and detection of 142 cancers, reducing the number of biopsies from 571 of 827 (69.0%) to 298 of 827 (36.0%). Conclusion When compared with full-field digital mammography, digital breast tomosynthesis can reduce the benign biopsy rate while maintaining the cancer detection rate. © RSNA, 2019 Online supplemental material is available for this article. See also the editorial by Skaane in this issue.

Purpose To examine the outcomes of a breast cancer screening program based on digital breast tomosynthesis (DBT) plus synthesized two-dimensional (2D) mammography compared with those after full-field digital mammography (FFDM). Materials and Methods This prospective study included 16 666 asymptomatic women aged 50-69 years who were recruited in April 2015 through March 2016 for DBT plus synthetic 2D screening in the Verona screening program. A comparison cohort of women screened with FFDM (n = 14 423) in the previous year was included. Screening detection measures for the two groups were compared by calculating the proportions associated with each outcome, and the relative rates (RRs) were estimated with multivariate logistic regression. Results Cancer detection rate (CDR) for DBT plus synthetic 2D imaging was 9.30 per 1000 screening examinations versus 5.41 per 1000 screening examinations with FFDM (RR, 1.72; 95% confidence interval [CI]: 1.30, 2.29). CDR was significantly higher in patients screened with DBT plus synthetic 2D imaging than in those screened with FFDM among women classified as having low breast density (RR, 1.53; 95% CI: 1.13, 2.10) or high breast density (RR, 2.86; 95% CI: 1.42, 6.25). The positive predictive value (PPV) for recall was almost doubled with DBT plus synthetic 2D imaging: 23.3% versus 12.9% of recalled patients who were screened with FFDM (RR, 1.81; 95% CI: 1.34, 2.47). The recall rate was similar between groups (RR, 0.95; 95% CI: 0.84, 1.06), whereas the recall rate with invasive assessment was higher for DBT plus synthetic 2D imaging than for FFDM (RR, 1.93; 95% CI: 1.31, 2.03). The mean number of screening studies interpreted per hour was significantly lower for screening examinations performed with DBT plus synthetic 2D imaging (38.5 screens per hour) than with FFDM (60 screens per hour) (P < .001). Conclusion DBT plus synthetic 2D imaging increases CDRs with recall rates comparable to those of FFDM. DBT plus synthetic 2D imaging increased image reading time and the time needed for invasive assessments. © RSNA, 2017.

To evaluate the tumour visibility and diagnostic performance of digital breast tomosynthesis (DBT) in patients with noncalcified T1 breast cancer. Medical records of 106 females with noncalcified T1 invasive breast cancer who underwent DBT and full-field digital mammography (FFDM) between January 2012 and December 2014 were retrospectively reviewed. To assess tumour visibility (score 1-3), all DBT and FFDM images were reviewed by two radiologists blinded to clinicopathological information. A reference standard was established by an unblinded consensus review of all images. Clinicopathological and imaging variables were analysed based on tumour visibility. After adding 159 negative controls, the diagnostic performance of DBT + FFDM was compared with that of FFDM. The tumour visibility was significantly higher through DBT + FFDM (2.5 vs 1.8; p = 0.002) than FFDM alone. Breast composition was the independent variable for tumour visibility through DBT + FFDM (extremely dense; odds ratio, 0.02; p < 0.001). Sensitivity (p = 0.642), specificity (p = 0.463), positive-predictive value (p = 0.078), and negative-predictive value (p = 0.072) of DBT + FFDM were not significantly superior to those of FFDM in 55 females with extremely dense breast composition, whereas specificity (p = 0.002) and positive-predictive value (p < 0.001) were significantly higher in 210 females with other breast compositions. Addition of DBT to FFDM showed no significant increase in the tumour visibility and diagnostic performance in patients with noncalcified T1 cancer in extremely dense breasts. Addition of DBT to FFDM did not further improve the detection of noncalcified early breast cancers in females with extremely dense breasts.

Objective: This study aimed to compare two-dimensional (2D) synthetic mammography (SM) and conventional 2D full-field digital mammography (FFDM) in the evaluation of breast lesions. We aim to determine whether SM, when combined with digital breast tomosynthesis (DBT), can serve as a new standard suitable for clinical adoption. This potential shift could impact existing screening protocols, offering benefits such as improved patient outcomes, maintained diagnostic accuracy, and workflow efficiency. Implementing SM+DBT may reduce radiation exposure, streamline image acquisition, and maintain diagnostic detail. This protocol could also increase patient throughput by minimizing image capture time and may enable more frequent, guideline-aligned screenings, ultimately supporting healthcare delivery efficiency from a clinical perspective. Mammograms from 100 patients wi Material And Method: th suspected breast pathologies were obtained using the Hologic Selenia Dimensions System in COMBO HD mode, generating FFDM, DBT, and SM images. FFDM and SM images were independently assessed using the 5th edition ACR Breast Imaging Reporting and Data System (5th edition BI-RADS) lexicon and compared. Institutional review board approval and patient consent were obtained. Spiculated margins and fine Result: pleomorphic calcifications were more distinctly visualised on SM images. FFDM images provided a more precise visualisation of nipple retraction and skin thickening. There was no significant difference in average glandular dose between FFDM and SM images (p = 0.12). BIRADS categorisation showed complete agreement across both methods in all cases. FFDM and SM images Conclusion: provided equivalent diagnostic performance for breast lesion evaluation. Combining DBT with SM reduced patient radiation dose without compromising diagnostic accuracy. Synthetic mammography may be considered a viable alternative to full-field digital mammogra Advances In Knowledge: phy when combined with digital breast tomosynthesis.

The purpose of this study was to analyze the clinicopathologic and immunohistochemical features of invasive breast cancers detected only with digital breast tomosynthesis (DBT), compared with those of cancers detected with both DBT and full-field digital mammography (FFDM). The medical records of 261 women (108 without and 153 with symptoms) with invasive breast cancers who underwent FFDM and DBT between April 2015 and June 2016 were retrospectively reviewed. To assess detectability, all DBT and FFDM images were reviewed independently by three radiologists blinded to clinicopathologic information. The reference standard was established by an unblinded consensus review of all images. Clinicopathologic and immunohistochemical features were analyzed according to the detectability status. Of the 261 cancers, 223 (85.4%) were detected with both DBT and FFDM (both-detected group). Twenty-four cancers (9.2%) not detected with FFDM (DBT-only group) were classified by DBT as a mass (58.3%), architectural distortion (33.3%), or asymmetry (8.3%). The remaining 14 cancers (5.4%) were not detected with either DBT or FFDM (both-occult group). On multivariate analysis, a dense breast parenchyma (p = 0.007), small tumor size (≤ 2 cm; p = 0.027), and luminal A-like subtype (estrogen receptor positive or progesterone receptor positive or both, human epidermal growth factor receptor 2 negative, and Ki-67 expression < 14%; p = 0.008) were significantly associated with the DBT-only group. For 108 screening-detected cancers, a dense breast parenchyma (p = 0.007) and luminal A-like subtype (p = 0.008) also maintained significance. The addition of DBT to FFDM in screening would aid in the detection of less-aggressive subtypes of invasive breast cancers in women with dense breasts.

Recall Rate Reduction with Tomosynthesis During Baseline Screening Examinations: An Assessment From a Prospective Trial

Purpose. Report advances being made in synthetic mammography applied to carbon nanotube-enabled stationary digital breast tomosynthesis (sDBT). Methods. The potential value of adding Laplacian decomposition, feature-enhancement algorithms, and weighted recombination to the tunable forward-projection steps developed previously to generate synthetic mammograms for sDBT was studied in this phantom-based comparison of sDBT to full field digital mammography (FFDM) and moving-source or conventional DBT. Contrast-to-noise ratio (CNR) and the full-width-at-half-maximum (FWHM) of the signal intensity were used to compare the display of microcalcification and mass features in the FFDM image and the synthetic images generated by sDBT and DBT. These findings guided modifications in the sDBT image processing chain, seeking to maximize the display of clinically-important features in the sDBT-based synthetic image. Results. Decomposing each reconstructed image slice into its high, mid, and low-frequency components yielded images emphasizing a different feature of clinical importance: microcalcifications, masses, and background density. Applying feature-enhancement algorithms to these images followed by weighted recombination during forward projection yielded an sDBT-based synthetic image that displayed masses with a higher CNR than the FFDM image and the synthetic image generated by DBT. Additionally, microcalcifications that could be visualized in all three modalities were displayed with a higher CNR in the synthetic images generated by DBT and sDBT compared to the FFDM image. Conclusion. Adding Laplacian decomposition, feature-enhancement, and weighted recombination steps to the image processing chain that generates a synthetic image from information collected by sDBT improved the display of clinicallyimportant features. Advancing the synthetic mammography capability of sDBT is important, as it will help complete the evolution of this promising technology to a viable clinical tool.

The purpose of our study was to quantitatively compare the time for interpretation of screening full-field digital mammography (FFDM) images using prior analog film mammograms for comparison versus digitized prior analog mammograms. Images from 100 FFDM studies were interpreted by four radiologists. All FFDM images had comparison analog mammograms obtained a minimum of 1 year earlier that were digitized using a 43-μm film digitizer. Initially, the FFDM images were interpreted using the digitized prior mammogram on two, 5-megapixel monitors and PACS. All available PACS tools could be used. Four weeks later, the same 100 screening FFDMs were interpreted using the original analog mammograms on an alternator at 90° to the monitors used to interpret the screening FFDMs. The interpretation times were recorded and compared. The results were compared and evaluated for statistical significance using statistical software, with statistical significance set at p < 0.05. For each radiologist, the mean reading time for FFDM with digitized priors was significantly shorter in length in comparison with the mean reading time calculated for interpreting FFDM using analog film priors. The differences in times recorded between digitized analog versus analog ranged from 11.31 to 74.18 seconds. The reading times for the four readers ranged from 17.32 to 185.94 seconds, with a mean of 58.56 seconds when using analog film prior mammograms. When using digitized analog prior mammograms, the reading times for the four readers ranged from 11.32 to 109.11 seconds with a mean of 39.76 seconds. The average difference in reading time was calculated to be 18.80 seconds, showing that there is a 32% increase in interpretation speed when using a digitized prior analog for comparison studies as opposed to an analog prior. There is a statistically significant 32.1% average improvement in interpretation time when FFDM screening mammograms use digitized analog comparison mammograms than if FFDM is interpreted with the original analog film mammograms. This should allow more FFDMs to be interpreted in the same amount of time if digitized prior analog mammograms are used.

Over-diagnosis in screening by mammography: A follow-up of the Malmö Mammographic Screening Trial, MMST

Realistic breast phantoms serve as important tools when evaluating full field digital mammography (FFDM) and digital breast tomosynthesis (DBT) system modifications. Current breast phantoms contain either unrealistic features or uniform backgrounds. The purpose of this work was to introduce a novel, task-based methodology for evaluating FFDM and DBT systems using an anthropomorphic inkjet-printed 3D phantom with clinically relevant signals. The methodology consists of multiple physical components: an anthropomorphic breast phantom, microcalcifications made of two types of material, and masses. A 4 cm compressed thickness breast phantom was first modeled analytically, then realized in a slice-by-slice fashion using inkjet printing with iohexol-doped ink. The microcalcifications (MCs) were made by arranging individual specks of varying sizes into regular patterns. Two types of MCs were used, ranging in diameter from 150 μm to 260 μm: one made from calcium hydroxyapatite (HA) and another from soda lime glass microspheres. Lastly, realistically-shaped masses were created using ink doped with potassium iodide. The phantom was imaged on two commercially available FFDM/DBT systems, Holgic Selenia Dimensions and the GE Senographe Essential. A typical mammographic beam was used (according to the automatic exposure control for each commercial system), and a similar average glandular dose was maintained across the systems. A pilot study consisting of a four-alternative, forced-choice (4AFC) analysis with human observers was performed on the FFDM and DBT acquisitions. The linear attenuation coefficients of the microcalcification models were measured to be similar to reference values. A custom Matlab program was created to extract ROI images from images of the phantom, each containing a signal, in preparation for use with 4AFC software. A pilot 4AFC study showed the visibility of the microcalcifications ranged from easy to difficult, and results informed the final reader study. An anthropomorphic breast phantom was created using inexpensive, easily available materials. The task-based assessment was performed on clinical FFDM and DBT systems. This promising phantom generation methodology can be used to objectively evaluate task performance resulting with FFDM and DBT breast imaging systems.

Introduction: Digital breast tomosynthesis (DBT) may decrease recall rates (RRs) and improve positive predictive values (PPVs) and cancer detection rates (CDRs) versus full-field digital mammography (FFDM). The value of DBT has not been assessed in New Mexico's rural and minority population. Objectives of this study were to compare RRs, CDRs, and PPVs using FFDM+DBT versus FFDM in screening mammograms at the University of New Mexico between 2013 and 2016 and to qualitatively evaluate patient decision-making regarding DBT. Materials and Methods: RRs, CDRs, and PPVs with 95% confidence intervals and relative risk were calculated from 35,147 mammograms. The association between relative risk and mammography approach was tested using Pearson's chi-square test. Twenty women undergoing screening were interviewed for qualitative evaluation of decision-making. Results: From 2013 to 2016, RRs were 8.4% and 11.1% for FFDM+DBT and FFDM, respectively. The difference in RRs became more pronounced with time. No significant difference was observed in PPVs or CDRs. Qualitative interviews revealed that the majority had limited prior knowledge of DBT and relied on provider recommendations. Conclusion: In New Mexico women undergoing screening mammography, a 30% relative risk reduction in RRs was observed with FFDM+DBT. Qualitative interviews suggest that women are aware of and receptive to DBT, assuming adequate educational support. Clinical Trials.gov ID: NCT03979729.

BACKGROUND. Studies establishing the validity of BI-RADS category 3 excluded patients with personal history of breast cancer (PHBC). Use of category 3 in patients with PHBC may be impacted not only by this population's increased breast cancer risk, but also by adoption of digital breast tomosynthesis (DBT) over full-field digital mammography (FFDM). OBJECTIVE. The purpose of this article was to compare the frequency, outcomes, and additional characteristics of BI-RADS category 3 assessments between FFDM and DBT in patients with PHBC. METHODS. This retrospective study included 14,845 mammograms in 10,118 patients (mean age, 63 years) with PHBC who had undergone mastectomy and/or lumpectomy. Of these, 8422 examinations were performed by FFDM from October 2014 to September 2016, and 6423 examinations by FFDM with DBT from February 2017 to December 2018, after interval conversion of the center's mammography units. Information was extracted from the EHR and radiology reports. FFDM and DBT groups were compared in the entire sample and among index category 3 lesions (i.e., earliest category 3 assessment per lesion). RESULTS. The frequency of category 3 assessment was lower for DBT than FFDM (5.6% vs 6.4%; p = .05). DBT, compared with FFDM, showed a lower malignancy rate for category 3 lesions (1.8% vs 5.0%; p = .04), higher malignancy rate for category 4 lesions (32.0% vs 23.2%; p = .03), and no difference in malignancy rate for category 5 lesions (100.0% vs 75.0%; p = .24). Analysis of index category 3 lesions included 438 and 274 lesions for FFDM and DBT, respectively. For category 3 lesions, DBT, compared with FFDM, showed lower PPV3 (13.9% vs 36.1%; p = .02) and a more frequent mammographic finding of mass (33.2% vs 23.1%; p = .003). CONCLUSION. The malignancy rate for category 3 lesions in patients with PHBC was less than the accepted limit (2%) for DBT (1.8%), but not FFDM (5.0%). A lower malignancy rate for category 3 lesions but higher malignancy rate for category 4 lesions for DBT supports more appropriate application of category 3 assessment in patients with PHBC through use of DBT. CLINICAL IMPACT. These insights may help establish whether category 3 assessments in patients with PHBC are within benchmarks for early detection of second cancers and reduction of benign biopsies.

The main barrier to adoption of digital breast tomosynthesis (DBT) plus full-field digital mammography (FFDM) is radiation exposure dose. The purpose of this study was to evaluate the diagnostic performance of DBT plus FFDM, both with newly developed technology (nd), at a dose comparable to that of the conventional FFDM alone. Nine hundred and thirteen participants were recruited from May 2014 to January 2016 consecutively. For each subject, the exposure setting for DBT(nd)+FFDM(nd) was also used for the conventional FFDM alone. Retrospective reader studies were performed: DBT(nd)+FFDM(nd) (142 cases, including 42 cancer cases) and conventional FFDM (258 cases, including 87 cancer cases). Eight radiologists provided Japanese categorizations and probability of malignancy independently. Diagnostic performance was assessed by comparing sensitivity, specificity, and area under the receiver operating characteristic curve (AUC). Two-sided P values were calculated. DBT(nd)+FFDM(nd) showed sensitivity and AUC significantly increased over the conventional FFDM (85.4 vs. 80.3%, P=0.015 and 90.9 vs. 88.3%, P=0.049) and specificity did not significantly increase (89.6 vs. 88.4%, P=0.52). The mean glandular dose (MGD) difference of DBT(nd)+FFDM(nd) and conventional FFDM was not significant (difference -0.11mGy, P=0.08). In this study population, DBT plus FFDM, both with newly developed technology, provided diagnostic performance improved over the conventional FFDM alone, even at comparable MGD.

Full-field digital mammography (FFDM), the standard of care for breast cancer screening, has some limitations. With the advent of digital breast tomosynthesis (DBT), improvements including decreased recall rates and increased cancer detection rates have been observed. The quasi-three-dimensional capability of DBT reduces breast tissue overlap, a significant limitation of FFDM. However, early studies demonstrate that a few cancers detected at FFDM may not be diagnosed at DBT-only screening, and lesions with calcifications as the dominant feature may look less suspicious at DBT or not be visible at all. These findings support the use of combined FFDM and DBT protocols to optimize screening performance. However, this combination would approximately double the patient's radiation exposure. The development of computer algorithms that generate two-dimensional synthesized mammography (SM) views from DBT has improved calcification conspicuity and sensitivity. Therefore, SM may substitute for FFDM in screening protocols, reducing radiation exposure. DBT plus SM demonstrates significantly better performance than that of FFDM alone, although there are reports of missed malignant calcifications. Thus, some centers continue to perform FFDM with DBT. Use of DBT in breast imaging has also necessitated the development of DBT-guided biopsy. DBT-guided biopsy may have a higher success rate than that of stereotactic biopsy, with a shorter procedure time. While DBT brings substantial improvements to breast cancer imaging, it is important to be aware of its strengths and limitations regarding detection of calcifications. This article reviews the imaging appearance of breast calcifications at DBT, discusses calcification biopsy techniques, and provides an overview of the current literature. Online supplemental material is available for this article. ©RSNA, 2019 An earlier incorrect version of this article appeared online. This article was corrected on February 13, 2019.

PurposeTo analyse digital breast tomosynthesis (DBT) reading times in the screening setting, compared to 2D full-field digital mammography (FFDM), and investigate the impact of reader experience and professional group on interpretation times. MethodReading time data were recorded in the PROSPECTS Trial, a prospective randomised trial comparing DBT plus FFDM or synthetic 2D mammography (S2D) to FFDM alone, in the National Health Service (NHS) breast screening programme, from January 2019-February 2023. Time to read DBT+FFDM or DBT+S2D and FFDM alone was calculated per case and reading times were compared between modalities using dependent T-tests. Reading times were compared between readers from different professional groups (radiologists and radiographer readers) and experience levels using independent T-tests. The learning curve effect of using DBT in screening on reading time was investigated using a Kruskal-Wallis test. ResultsForty-eight readers interpreted 1,242 FFDM batches (34,210 FFDM cases) and 973 DBT batches (13,983 DBT cases). DBT reading time was doubled compared to FFDM (2.09 ± 0.64 min vs. 0.98 ± 0.30 min; p < 0.001), and DBT+S2D reading was longer than DBT + FFDM (2.24 ± 0.62 min vs. 2.04 ± 0.46 min; p = 0.006). No difference was identified in reading time between radiologists and radiographers (2.06 ± 0.71 min vs. 2.14 ± 0.46 min, respectively; p = 0.71). Readers with five or more years of experience reading DBT were quicker than those with less experience (1.86 ± 0.56 min vs. 2.37 ± 0.65 min; p = 0.008), and DBT reading time decreased after less than 9 months accrued screening experience (p = 0.01). ConclusionsDBT reading times were double those of FFDM in the screening setting, but there was a short learning curve effect with readers showing significant improvements in reading times within the first nine months of DBT experience.ClinicalTrials.gov Identifier: NCT03733106.