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Breast Imaging Reporting and Data System (BI-RADS) breast composition descriptors: automated measurement development for full field digital mammography.

ABSTRACT: The Breast Imaging Reporting and Data System (BI-RADS) breast composition descriptors are used for standardized mammographic reporting and are assessed visually. This reporting is clinically relevant because breast composition can impact mammographic sensitivity and is a breast cancer risk factor. New techniques are presented and evaluated for generating automated BI-RADS breast composition descriptors using both raw and calibrated full field digital mammography (FFDM) image data.A matched case-control dataset with FFDM images was used to develop three automated measures for the BI-RADS breast composition descriptors. Histograms of each calibrated mammogram in the percent glandular (pg) representation were processed to create the new BR(pg) measure. Two previously validated measures of breast density derived from calibrated and raw mammograms were converted to the new BR(vc) and BR(vr) measures, respectively. These three measures were compared with the radiologist-reported BI-RADS compositions assessments from the patient records. The authors used two optimization strategies with differential evolution to create these measures: method-1 used breast cancer status; and method-2 matched the reported BI-RADS descriptors. Weighted kappa (κ) analysis was used to assess the agreement between the new measures and the reported measures. Each measure's association with breast cancer was evaluated with odds ratios (ORs) adjusted for body mass index, breast area, and menopausal status. ORs were estimated as per unit increase with 95% confidence intervals.The three BI-RADS measures generated by method-1 had κ between 0.25-0.34. These measures were significantly associated with breast cancer status in the adjusted models: (a) OR = 1.87 (1.34, 2.59) for BR(pg); (b) OR = 1.93 (1.36, 2.74) for BR(vc); and (c) OR = 1.37 (1.05, 1.80) for BR(vr). The measures generated by method-2 had κ between 0.42-0.45. Two of these measures were significantly associated with breast cancer status in the adjusted models: (a) OR = 1.95 (1.24, 3.09) for BR(pg); (b) OR = 1.42 (0.87, 2.32) for BR(vc); and (c) OR = 2.13 (1.22, 3.72) for BR(vr). The radiologist-reported measures from the patient records showed a similar association, OR = 1.49 (0.99, 2.24), although only borderline statistically significant.A general framework was developed and validated for converting calibrated mammograms and continuous measures of breast density to fully automated approximations for the BI-RADS breast composition descriptors. The techniques are general and suitable for a broad range of clinical and research applications.

SUBMITTER: Fowler EE

PROVIDER: S-EPMC3820635 | biostudies-other | 2013 Nov

REPOSITORIES: biostudies-other

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Project description:Purpose To determine the utilization and positive predictive value (PPV) of the American College of Radiology (ACR) Breast Imaging Data and Reporting System (BI-RADS) category 4 subdivisions in diagnostic mammography in the National Mammography Database (NMD). Materials and Methods This study involved retrospective review of diagnostic mammography data submitted to the NMD from January 1, 2008 to December 30, 2014. Utilization rates of BI-RADS category 4 subdivisions were compared by year, facility (type, location, census region), and examination (indication, finding type) characteristics. PPV3 (positive predictive value for biopsies performed) was calculated overall and according to category 4 subdivision. The χ2 test was used to test for significant associations. Results Of 1 309 950 diagnostic mammograms, 125 447 (9.6%) were category 4, of which 33.3% (41 841 of 125 447) were subdivided. Subdivision utilization rates were higher (P < .001) in practices that were community, suburban, or in the West; for examination indication of prior history of breast cancer; and for the imaging finding of architectural distortion. Of 41 841 category 4 subdivided examinations, 4A constituted 55.6% (23 258 of 41 841) of the examinations; 4B, 31.8% (13 302 of 41 841) of the examinations; and 4C, 12.6% (5281 of 41 841) of the examinations. Pathologic outcomes were available in 91 563 examinations, and overall category 4 PPV3 was 21.1% (19 285 of 91 563). There was a statistically significant difference in PPV3 according to category 4 subdivision (P < .001): The PPV of 4A was 7.6% (1274 of 16 784), that of 4B was 22% (2317 of 10 408), and that of 4C was 69.3% (2839 of 4099). Conclusion Although BI-RADS suggests their use, subdivisions were utilized in the minority (33.3% [41 841 of 125 447]) of category 4 diagnostic mammograms, with variability based on facility and examination characteristics. When subdivisions were used, PPV3s were in BI-RADS-specified malignancy ranges. This analysis supports the use of subdivisions in broad practice and, given benefits for patient care, should motivate increased utilization. © RSNA, 2018 Online supplemental material is available for this article.

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:Optimization of exposure parameters (target, filter, and kVp) in digital mammography necessitates maximization of the image signal-to-noise ratio (SNR), while simultaneously minimizing patient dose. The goal of this study is to compare, for each of the major commercially available full field digital mammography (FFDM) systems, the impact of the selection of technique factors on image SNR and radiation dose for a range of breast thickness and tissue types. This phantom study is an update of a previous investigation and includes measurements on recent versions of two of the FFDM systems discussed in that article, as well as on three FFDM systems not available at that time. The five commercial FFDM systems tested, the Senographe 2000D from GE Healthcare, the Mammomat Novation DR from Siemens, the Selenia from Hologic, the Fischer Senoscan, and Fuji's 5000MA used with a Lorad M-IV mammography unit, are located at five different university test sites. Performance was assessed using all available x-ray target and filter combinations and nine different phantom types (three compressed thicknesses and three tissue composition types). Each phantom type was also imaged using the automatic exposure control (AEC) of each system to identify the exposure parameters used under automated image acquisition. The figure of merit (FOM) used to compare technique factors is the ratio of the square of the image SNR to the mean glandular dose. The results show that, for a given target/filter combination, in general FOM is a slowly changing function of kVp, with stronger dependence on the choice of target/filter combination. In all cases the FOM was a decreasing function of kVp at the top of the available range of kVp settings, indicating that higher tube voltages would produce no further performance improvement. For a given phantom type, the exposure parameter set resulting in the highest FOM value was system specific, depending on both the set of available target/filter combinations, and on the receptor type. In most cases, the AECs of the FFDM systems successfully identified exposure parameters resulting in FOM values near the maximum ones, however, there were several examples where AEC performance could be improved.

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Breast Imaging Reporting and Data System (BI-RADS) breast composition descriptors: automated measurement development for full field digital mammography.

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