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Diagnostic Performance of Digital Breast Tomosynthesis for Breast Suspicious Calcifications From Various Populations: A Comparison With Full-field Digital Mammography.

ABSTRACT: The diagnostic performance difference between digital breast tomosynthesis (DBT) and conventional full-field digital mammography (FFDM) for breast suspicious calcifications from various populations is unclear. The objective of this study is to determine whether DBT exhibits the diagnostic advantage for breast suspicious calcifications from various populations compared with FFDM. Three hundred and five patients were enrolled (of which seven patients with bilateral lesions) and 312 breasts images were retrospectively analyzed by three radiologists independently. The postoperative pathology of breast calcifications was the gold standard. Breast cancer was diagnosed utilizing DBT and FFDM with sensitivities of 92.9% and 88.8%, specificities of 87.9% and 75.2%, positive predictive values of 77.8% and 62.1%, negative predictive values of 96.4% and 93.6%, respectively. DBT exhibited significantly higher diagnostic accuracy for benign calcifications compared with FFDM (87.9% vs 75.2%), and no advantage in the diagnosis of malignant calcifications. DBT diagnostic accuracy was notably higher than FFDM in premenopausal (88.4% vs 78.8%), postmenopausal (90.2% vs 77.2%), and dense breast cases (89.4% vs 81.9%). There was no significant difference in non-dense breast cases. In our study, DBT exhibited a superior advantage in dense breasts and benign calcifications cases compared to FFDM, while no advantage was observed in non-dense breasts or malignant calcifications cases. Thus, in the breast cancer screening for young women with dense breasts, DBT may be recommended for accurate diagnosis. Our findings may assist the clinicians in applying the optimal techniques for different patients and provide a theoretical basis for the update of breast cancer screening guideline.

SUBMITTER: Li J

PROVIDER: S-EPMC6317146 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Diagnostic Performance of Digital Breast Tomosynthesis for Breast Suspicious Calcifications From Various Populations: A Comparison With Full-field Digital Mammography.

Li Juntao J Zhang Hengwei H Jiang Hui H Guo Xuhui X Zhang Yinli Y Qi Dan D Guan Jitian J Liu Zhenzhen Z Wu Erxi E Luo Suxia S

Computational and structural biotechnology journal 20181220

The diagnostic performance difference between digital breast tomosynthesis (DBT) and conventional full-field digital mammography (FFDM) for breast suspicious calcifications from various populations is unclear. The objective of this study is to determine whether DBT exhibits the diagnostic advantage for breast suspicious calcifications from various populations compared with FFDM. Three hundred and five patients were enrolled (of which seven patients with bilateral lesions) and 312 breasts images ...[more]

PMID: 30622686

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Project description:Importance:Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Simulation is increasingly being used in product development but rarely in regulatory applications. Objectives:To conduct a computer-simulated imaging trial evaluating digital breast tomosynthesis (DBT) as a replacement for digital mammography (DM) and to compare the results with a comparative clinical trial. Design, Setting, and Participants:The simulated Virtual Imaging Clinical Trial for Regulatory Evaluation (VICTRE) trial was designed to replicate a clinical trial that used human patients and radiologists. Images obtained with in silico versions of DM and DBT systems via fast Monte Carlo x-ray transport were interpreted by a computational reader detecting the presence of lesions. A total of 2986 synthetic image-based virtual patients with breast sizes and radiographic densities representative of a screening population and compressed thicknesses from 3.5 to 6 cm were generated using an analytic approach in which anatomical structures are randomly created within a predefined breast volume and compressed in the craniocaudal orientation. A positive cohort contained a digitally inserted microcalcification cluster or spiculated mass. Main Outcomes and Measures:The trial end point was the difference in area under the receiver operating characteristic curve between modalities for lesion detection. The trial was sized for an SE of 0.01 in the change in area under the curve (AUC), half the uncertainty in the comparative clinical trial. Results:In this trial, computational readers analyzed 31?055 DM and 27?960 DBT cases from 2986 virtual patients with the following Breast Imaging Reporting and Data System densities: 286 (9.6%) extremely dense, 1200 (40.2%) heterogeneously dense, 1200 (40.2%) scattered fibroglandular densities, and 300 (10.0%) almost entirely fat. The mean (SE) change in AUC was 0.0587 (0.0062) (P?<?.001) in favor of DBT. The change in AUC was larger for masses (mean [SE], 0.0903 [0.008]) than for calcifications (mean [SE], 0.0268 [0.004]), which was consistent with the findings of the comparative trial (mean [SE], 0.065 [0.017] for masses and -0.047 [0.032] for calcifications). Conclusions and Relevance:The results of the simulated VICTRE trial are consistent with the performance seen in the comparative trial. While further research is needed to assess the generalizability of these findings, in silico imaging trials represent a viable source of regulatory evidence for imaging devices.

Project description:INTRODUCTION:Development of digital breast tomosynthesis (DBT) provides a technology that generates three-dimensional data sets, thus reducing the pitfalls of overlapping breast tissue. Observational studies suggest that the combination of two-dimensional (2D) digital mammography and DBT increases diagnostic accuracy. However, because of duplicate exposure, this comes at the cost of an augmented radiation dose. This undesired adverse impact can be avoided by using synthesised 2D images reconstructed from the DBT data (s2D).We designed a diagnostic superiority trial on a high level of evidence with the aim of providing a comparison of screening efficacy parameters resulting from DBT+s2D versus the current screening standard 2D full-field digital mammography (FFDM) in a multicentre and multivendor setting on the basis of the quality-controlled, population-based, biennial mammography screening programme in Germany. METHODS AND ANALYSIS:80?000 women in the eligible age 50-69 years attending the routine mammography screening programme and willing to participate in the TOSYMA trial will be assigned by 1:1 randomisation to either the intervention arm (DBT+s2D) or the control arm (FFDM) during a 12-month recruitment period in screening units of North Rhine-Westphalia and Lower Saxony. State cancer registries will provide the follow-up of interval cancers.Primary endpoints are the detection rate of invasive breast cancers at screening examination and the cumulative incidence of interval cancers in the 2?years after a negative examination. Secondary endpoints are the detection rate of ductal carcinoma in situ and of tumour size T1, the recall rate for assessment, the positive predictive value of recall and the cumulative 12-month incidence of interval cancers. An adaptive statistical design with one interim analysis provides the option to modify the design. ETHICS AND DISSEMINATION:This protocol has been approved by the local medical ethical committee (2016-132-f-S). Results will be submitted to international peer-reviewed journals. TRIAL REGISTRATION:NCT03377036; Pre-results.

Project description:Background Breast Imaging Reporting and Data System (BI-RADS) breast density categories assigned by interpreting radiologists often influence decisions surrounding supplemental breast cancer screening and risk assessment. The landscape of mammographic screening continuously evolves, and different mammographic screening modalities may result in different perception of density, reflected in different assignment of BI-RADS density categories. Purpose To investigate the effect of screening mammography modality on BI-RADS breast density assessments. Materials and Methods Data were retrospectively analyzed from 24 736 individual women (42.3% [10 455 of 24 736] white women, 57.7% [14 281 of 24 736] black women; mean age, 56.3 years; age range, 40.0-74.9 years) who underwent from one to seven mammographic screening examinations from September 2010 through February 2017 (60 766 examinations). Three screening modalities were used: digital mammography alone (8935 examinations); digital mammography with digital breast tomosynthesis (DBT; 30 779 examinations); and synthetic mammography with DBT (21 052 examinations). Random-effects logistic regression analysis was performed to estimate the likelihood of assignment to high versus low BI-RADS density category according to each modality, adjusted for ethnicity, age, body mass index (BMI), and radiologist. The interactions of modality with ethnicity and BMI on density categorization were also tested with the model. Results Women screened with DBT versus digital mammography alone had lower likelihood regarding categorization of high density breasts (digital mammography and DBT vs digital mammography: odds ratio, 0.69 [95% confidence interval: 0.61, 0.80], P < .001; synthetic mammography and DBT vs digital mammography: odds ratio, 0.43 [95% confidence interval: 0.37, 0.50], P < .001). Lower likelihood of high density was also observed at synthetic mammography and DBT compared with digital mammography and DBT (odds ratio, 0.62; 95% confidence interval: 0.56, 0.69; P < .001). There were interactions of modality with ethnicity (P = .007) and BMI (P = .003) on breast density assessment, with greater differences in density categorization according to modality observed for black women than for white women and groups with higher BMI. Conclusion Breast density categorization may vary by screening mammographic modality, and this effect appears to vary by ethnicity and body mass index. © RSNA, 2019 Online supplemental material is available for this article. See also the editorial by Philpotts in this issue.

Project description:ImportanceMany US radiologists have screening mammography recall rates above the expert-recommended threshold of 12%. The influence of digital breast tomosynthesis (DBT) on the distribution of radiologist recall rates is uncertain.ObjectiveTo evaluate radiologists' recall and cancer detection rates before and after beginning interpretation of DBT examinations.Design, setting, and participantsThis cohort study included 198 radiologists from 104 radiology facilities in the Breast Cancer Surveillance Consortium who interpreted 251?384 DBT and 2?000?681 digital mammography (DM) screening examinations from 2009 to 2017, including 126 radiologists (63.6%) who interpreted DBT examinations during the study period and 72 (36.4%) who exclusively interpreted DM examinations (to adjust for secular trends). Data were analyzed from April 2018 to July 2019.ExposuresDigital breast tomosynthesis and DM screening examinations.Main outcomes and measuresRecall rate and cancer detection rate.ResultsA total of 198 radiologists interpreted 2?252?065 DM and DBT examinations (2?000?681 [88.8%] DM examinations; 251?384 [11.2%] DBT examinations; 710?934 patients [31.6%] aged 50-59 years; 1?448?981 [64.3%] non-Hispanic white). Among the 126 radiologists (63.6%) who interpreted DBT examinations, 83 (65.9%) had unadjusted DM recall rates of no more than 12% before using DBT, with a median (interquartile range) recall rate of 10.0% (7.5%-13.0%). On DBT examinations, 96 (76.2%) had an unadjusted recall rate of no more than 12%, with a median (interquartile range) recall rate of 8.8% (6.3%-11.3%). A secular trend in recall rate was observed, with the multivariable-adjusted risk of recall on screening examinations declining by 1.2% (95% CI, 0.9%-1.5%) per year. After adjusting for examination characteristics and secular trends, recall rates were 15% lower on DBT examinations compared with DM examinations interpreted before DBT use (relative risk, 0.85; 95% CI, 0.83-0.87). Adjusted recall rates were significantly lower on DBT examinations compared with DM examinations interpreted before DBT use for 45 radiologists (35.7%) and significantly higher for 18 (14.3%); 63 (50.0%) had no statistically significant change. The unadjusted cancer detection rate on DBT was 5.3 per 1000 examinations (95% CI, 5.0-5.7 per 1000 examinations) compared with 4.7 per 1000 examinations (95% CI, 4.6-4.8 per 1000 examinations) on DM examinations interpreted before DM use (multivariable-adjusted risk ratio, 1.21; 95% CI, 1.11-1.33).Conclusions and relevanceIn this study, DBT was associated with an overall decrease in recall rate and an increase in cancer detection rate. However, our results indicated that there is wide variability among radiologists, including a subset of radiologists who experienced increased recall rates on DBT examinations. Radiology practices should audit radiologist DBT screening performance and consider additional DBT training for radiologists whose performance does not improve as expected.

Project description:BackgroundOur objective was to perform a systematic review and meta-analysis comparing the breast cancer detection rate (CDR), invasive CDR, recall rate, and positive predictive value 1 (PPV1) of digital mammography (DM) alone, combined digital breast tomosynthesis (DBT) and DM, combined DBT and synthetic 2-dimensional mammography (S2D), and DBT alone.MethodsMEDLINE and Embase were searched until April 2020 to identify comparative design studies reporting on patients undergoing routine breast cancer screening. Random effects model proportional meta-analyses estimated CDR, invasive CDR, recall rate, and PPV1. Meta-regression modeling was used to compare imaging modalities. All statistical tests were 2-sided.ResultsForty-two studies reporting on 2 606 296 patients (13 003 breast cancer cases) were included. CDR was highest in combined DBT and DM (6.36 per 1000 screened, 95% confidence interval [CI] = 5.62 to 7.14, P < .001), and combined DBT and S2D (7.40 per 1000 screened, 95% CI = 6.49 to 8.37, P < .001) compared with DM alone (4.68 per 1000 screened, 95% CI = 4.28 to 5.11). Invasive CDR was highest in combined DBT and DM (4.53 per 1000 screened, 95% CI = 3.97 to 5.12, P = .003) and combined DBT and S2D (5.68 per 1000 screened, 95% CI = 4.43 to 7.09, P < .001) compared with DM alone (3.42 per 1000 screened, 95% CI = 3.02 to 3.83). Recall rate was lowest in combined DBT and S2D (42.3 per 1000 screened, 95% CI = 37.4 to 60.4, P<.001). PPV1 was highest in combined DBT and DM (10.0%, 95% CI = 8.0% to 12.0%, P = .004), and combined DBT and S2D (16.0%, 95% CI = 10.0% to 23.0%, P < .001), whereas no difference was detected for DBT alone (7.0%, 95% CI = 6.0% to 8.0%, P = .75) compared with DM alone (7.0%, 95.0% CI = 5.0% to 8.0%).ConclusionsOur findings provide evidence on key performance metrics for DM, DBT alone, combined DBT and DM, and combined DBT and S2D, which may inform optimal application of these modalities for breast cancer screening.

Project description:Aim: This prospective clinical study aimed to evaluate whether it would be possible to reduce the rate of re-excisions using CMOS technology, a specimen radiography system (SRS) or digital breast tomosynthesis (DBT) compared to a conventional full field digital mammography (FFDM) system. Material and Method: Between 12/2012 and 2/2013 50 patients were diagnosed with invasive breast cancer (BI-RADS™ 5). After histological verification, all patients underwent breast-conserving therapy with intraoperative imaging using 4 different systems and differing magnifications: 1. Inspiration™ (Siemens, Erlangen, Germany), amorphous selenium, tungsten source, focus 0.1 mm, resolution 85 µm pixel pitch, 8 lp/mm; 2. BioVision™ (Bioptics, Tucson, AZ, USA), CMOS technology, photodiode array, flat panel, tungsten source, focus 0.05, resolution 50 µm pixel pitch, 12 lp/mm; 3. the Trident™ specimen radiography system (SRS) (Hologic, Bedford, MA, USA), amorphous selenium, tungsten source, focus 0.05, resolution 70 µm pixel pitch, 7.1 lp/mm; 4. tomosynthesis (Siemens, Erlangen, Germany), amorphous selenium, tungsten source, focus 0.1 mm, resolution 85 µm pixel pitch, 8 lp/mm, angular range 50 degrees, 25 projections, scan time > 20 s, geometry: uniform scanning, reconstruction: filtered back projection. The 600 radiographs were prospectively shown to 3 radiologists. Results: Of the 50 patients with histologically proven breast cancer (BI-RADS™ 6), 39 patients required no further surgical therapy (re-excision) after breast-conserving surgery. A retrospective analysis (n = 11) showed a significant (p < 0.05) increase of sensitivity with the BioVision™, the Trident™ and tomosynthesis compared to the Inspiration™ at a magnification of 1.0 : 2.0 or 1.0 : 1.0 (tomosynthesis) (2.6, 3.3 or 3.6 %), i.e. re-excision would not have been necessary in 2, 3 or 4 patients, respectively, compared to findings obtained with a standard magnification of 1.0 : 1.0. Conclusion: The sensitivity of the BioVision™, the Trident™ and tomosynthesis was significantly (p < 0.05) higher and the rate of re-excisions was reduced compared to FFDM using a conventional detector at a magnification of 2.0 but without zooming.

Dataset Information

Diagnostic Performance of Digital Breast Tomosynthesis for Breast Suspicious Calcifications From Various Populations: A Comparison With Full-field Digital Mammography.

Publications

Diagnostic Performance of Digital Breast Tomosynthesis for Breast Suspicious Calcifications From Various Populations: A Comparison With Full-field Digital Mammography.

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