Diagnostic Performance of Digital Breast Tomosynthesis for Breast Suspicious Calcifications From Various Populations: A Comparison With Full-field Digital Mammography.
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ABSTRACT:
SUBMITTER: Li J
PROVIDER: S-EPMC6317146 | biostudies-literature | 2019
REPOSITORIES: biostudies-literature
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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.
| S-EPMC6324392 | biostudies-literature
Project description:OBJECTIVE: To compare breast density estimated from two-dimensional full-field digital mammography (2D FFDM) and from digital breast tomosynthesis (DBT) according to different Breast Imaging-Reporting and Data System (BI-RADS) categories, using automated software. METHODS: Institutional review board approval and written informed patient consent were obtained. DBT and 2D FFDM were performed in the same patients to allow within-patient comparison. A total of 160 consecutive patients (mean age: 50±14 years; mean body mass index: 22±3) were included to create paired data sets of 40 patients for each BI-RADS category. Automatic software (MedDensity(©), developed by Giulio Tagliafico) was used to compare the percentage breast density between DBT and 2D FFDM. The estimated breast percentage density obtained using DBT and 2D FFDM was examined for correlation with the radiologists' visual BI-RADS density classification. RESULTS: The 2D FFDM differed from DBT by 16.0% in BI-RADS Category 1, by 11.9% in Category 2, by 3.5% in Category 3 and by 18.1% in Category 4. These differences were highly significant (p<0.0001). There was a good correlation between the BI-RADS categories and the density evaluated using 2D FFDM and DBT (r=0.56, p<0.01 and r=0.48, p<0.01, respectively). CONCLUSION: Using DBT, breast density values were lower than those obtained using 2D FFDM, with a non-linear relationship across the BI-RADS categories. These data are relevant for clinical practice and research studies using density in determining the risk. ADVANCES IN KNOWLEDGE: On DBT, breast density values were lower than with 2D FFDM, with a non-linear relationship across the classical BI-RADS categories.
| S-EPMC3830430 | biostudies-other
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.
| S-EPMC5961594 | biostudies-literature
Project description:Aim: The aim of this prospective clinical study was to assess whether it would be possible to reduce the rate of re-excisions and improve the quality using CMOS technology or digital breast tomosynthesis (DBT) compared to a conventional FFDM system. Material and Methods: An invasive breast cancer (BI-RADS 5) was diagnosed in 200 patients in the period from 5/2011 to 1/2012. After histological verification, a breast-conserving therapy was performed with intraoperative imaging. Three different imaging systems were used: 1) Inspiration™ (Siemens, Erlangen, Germany), amorphous selenium, tungsten source, focus 0.1?mm, resolution 85?µm pixel pitch, 8?l/mm as the standard; 2) BioVision™ (Bioptics, Tucson, USA), flat panel photodiode array, tungsten source, focus 0.05, resolution 50?µm pixel pitch, 12?l/mm; 3) Tomosynthesis (Siemens, Erlangen, Germany), amorphous selenium, tungsten source, focus 0.1?mm, resolution 85?µm pixel pitch, 8?l/mm, range: 50°, 25 projections, scan time >?20?s, geometry: uniform scanning, reconstruction: filtered back projection. The 600 radiograms were prospectively shown to 3 radiologists. Results: Out of a total of 200 patients with histologically confirmed breast cancer (BI-RADS 6) 156 patients required no further operative therapy (re-excision) after breast-conserving therapy. A retrospective analysis (n?=?44) showed an increase in sensitivity with tomosynthesis compared to the BioVision™ (CMOS technology) and the Inspiration™ at a magnification of 1.0?:?1.0 of 8?% (p?<?0.05), i.e. re-excision would not have been necessary in 16 patients with tomosynthesis. Conclusions: The sensitivity of tomosynthesis for intraoperative radiography is significantly (p?<?0.05) higher compared to both CMOS technology and an FFDM system with a conventional detector. Additional studies using higher magnification, e.g. 2.0?:?1.0, but no zooming will be necessary to evaluate the method further.
| S-EPMC4651156 | biostudies-literature
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.
| S-EPMC6493215 | biostudies-literature
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.
| S-EPMC7292996 | biostudies-literature
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.
| S-EPMC8168096 | biostudies-literature
Project description:BackgroundDigital breast tomosynthesis (DBT) has become a prevalent mode of breast cancer screening in recent years. Although older women are commonly screened for breast cancer, little is known about screening outcomes using DBT among older women.ObjectiveTo assess proximal screening outcomes with DBT compared to traditional two-dimensional(2-D) mammography among women 67-74 and women 75 and older.DesignCohort study.ParticipantsMedicare fee-for-service beneficiaries aged 67 years and older with no history of prior cancer who received a screening mammogram in 2015.Main measuresUse of subsequent imaging (ultrasound and diagnostic mammography) as an indication of recall, breast cancer detection, and characteristics of breast cancer at the time of diagnosis. Analyses used weighted logistic regression to adjust for potential confounders.Key resultsOur study included 26,406 women aged 67-74 and 17,001 women 75 and older who were screened for breast cancer. Among women 75 and older, the rate of subsequent imaging among women screened with DBT did not differ significantly from 2-D mammography (91.8 versus 97.0 per 1,000 screening mammograms, p=0.37). In this age group, DBT was associated with 2.1 additional cancers detected per 1,000 screening mammograms compared to 2D (11.5 versus 9.4, p=0.003), though these additional cancers were almost exclusively in situ and stage I invasive cancers. For women 67-74 years old, DBT was associated with a higher rate of subsequent imaging than 2-D mammography (113.9 versus 100.3, p=0.004) and a higher rate of stage I invasive cancer detection (4.7 versus 3.7, p=0.002), but not other stages.ConclusionsBreast cancer screening with DBT was not associated with lower rates of subsequent imaging among older women. Most additional cancers detected with DBT were early stage. Whether detecting these additional early-stage cancers among older women improves health outcomes remains uncertain.
| S-EPMC8483166 | biostudies-literature
Project description:PurposeTo develop a Breast Imaging Reporting and Data System (BI-RADS) breast density deep learning (DL) model in a multisite setting for synthetic two-dimensional mammographic (SM) images derived from digital breast tomosynthesis examinations by using full-field digital mammographic (FFDM) images and limited SM data.Materials and methodsA DL model was trained to predict BI-RADS breast density by using FFDM images acquired from 2008 to 2017 (site 1: 57 492 patients, 187 627 examinations, 750 752 images) for this retrospective study. The FFDM model was evaluated by using SM datasets from two institutions (site 1: 3842 patients, 3866 examinations, 14 472 images, acquired from 2016 to 2017; site 2: 7557 patients, 16 283 examinations, 63 973 images, 2015 to 2019). Each of the three datasets were then split into training, validation, and test. Adaptation methods were investigated to improve performance on the SM datasets, and the effect of dataset size on each adaptation method was considered. Statistical significance was assessed by using CIs, which were estimated by bootstrapping.ResultsWithout adaptation, the model demonstrated substantial agreement with the original reporting radiologists for all three datasets (site 1 FFDM: linearly weighted Cohen κ [κw] = 0.75 [95% CI: 0.74, 0.76]; site 1 SM: κw = 0.71 [95% CI: 0.64, 0.78]; site 2 SM: κw = 0.72 [95% CI: 0.70, 0.75]). With adaptation, performance improved for site 2 (site 1: κw = 0.72 [95% CI: 0.66, 0.79], 0.71 vs 0.72, P = .80; site 2: κw = 0.79 [95% CI: 0.76, 0.81], 0.72 vs 0.79, P < .001) by using only 500 SM images from that site.ConclusionA BI-RADS breast density DL model demonstrated strong performance on FFDM and SM images from two institutions without training on SM images and improved by using few SM images.Supplemental material is available for this article.Published under a CC BY 4.0 license.
| S-EPMC8082294 | biostudies-literature
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.
| S-EPMC3864442 | biostudies-literature