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Full Field Digital Mammography (FFDM) versus CMOS Technology, Specimen Radiography System (SRS) and Tomosynthesis (DBT) - Which System Can Optimise Surgical Therapy?

ABSTRACT: 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?Conclusion: The sensitivity of the BioVision™, the Trident™ and tomosynthesis was significantly (p?

SUBMITTER: Schulz-Wendtland R

PROVIDER: S-EPMC3864442 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

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Full Field Digital Mammography (FFDM) versus CMOS Technology, Specimen Radiography System (SRS) and Tomosynthesis (DBT) - Which System Can Optimise Surgical Therapy?

Schulz-Wendtland R R Dilbat G G Bani M M Fasching P A PA Heusinger K K Lux M P MP Loehberg C R CR Brehm B B Hammon M M Saake M M Dankerl P P Jud S M SM Rauh C C Bayer C M CM Beckmann M W MW Uder M M Meier-Meitinger M M

Geburtshilfe und Frauenheilkunde 20130501 5

<b>Aim:</b> 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. <b>Material and Method:</b> 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 therap ...[more]

PMID: 24771921

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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:Purpose To conduct a multi-institutional, multireader study to compare the performance of digital tomosynthesis, dual-energy (DE) imaging, and conventional chest radiography for pulmonary nodule detection and management. Materials and Methods In this binational, institutional review board-approved, HIPAA-compliant prospective study, 158 subjects (43 subjects with normal findings) were enrolled at four institutions. Informed consent was obtained prior to enrollment. Subjects underwent chest computed tomography (CT) and imaging with conventional chest radiography (posteroanterior and lateral), DE imaging, and tomosynthesis with a flat-panel imaging device. Three experienced thoracic radiologists identified true locations of nodules (n = 516, 3-20-mm diameters) with CT and recommended case management by using Fleischner Society guidelines. Five other radiologists marked nodules and indicated case management by using images from conventional chest radiography, conventional chest radiography plus DE imaging, tomosynthesis, and tomosynthesis plus DE imaging. Sensitivity, specificity, and overall accuracy were measured by using the free-response receiver operating characteristic method and the receiver operating characteristic method for nodule detection and case management, respectively. Results were further analyzed according to nodule diameter categories (3-4 mm, >4 mm to 6 mm, >6 mm to 8 mm, and >8 mm to 20 mm). Results Maximum lesion localization fraction was higher for tomosynthesis than for conventional chest radiography in all nodule size categories (3.55-fold for all nodules, P < .001; 95% confidence interval [CI]: 2.96, 4.15). Case-level sensitivity was higher with tomosynthesis than with conventional chest radiography for all nodules (1.49-fold, P < .001; 95% CI: 1.25, 1.73). Case management decisions showed better overall accuracy with tomosynthesis than with conventional chest radiography, as given by the area under the receiver operating characteristic curve (1.23-fold, P < .001; 95% CI: 1.15, 1.32). There were no differences in any specificity measures. DE imaging did not significantly affect nodule detection when paired with either conventional chest radiography or tomosynthesis. Conclusion Tomosynthesis outperformed conventional chest radiography for lung nodule detection and determination of case management; DE imaging did not show significant differences over conventional chest radiography or tomosynthesis alone. These findings indicate performance likely achievable with a range of reader expertise. © RSNA, 2016 Online supplemental material is available for this article.

Dataset Information

Full Field Digital Mammography (FFDM) versus CMOS Technology, Specimen Radiography System (SRS) and Tomosynthesis (DBT) - Which System Can Optimise Surgical Therapy?

Publications

Full Field Digital Mammography (FFDM) versus CMOS Technology, Specimen Radiography System (SRS) and Tomosynthesis (DBT) - Which System Can Optimise Surgical Therapy?

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