Digital Breast Tomosynthesis System Approved for Use in Europe

Of the 43 institutes with the technology installed, Dr. Laurent Levy, from the Institute de Radiologie de Hoche (Paris, France) has analyzed more than 400 breast exams with this technology. SenoClaire, powered by ASiR (adaptive statistical iterative reconstruction) DBT, provides excellent sensitivity for architectural distortions and masses, providing more clinical effectiveness while delivering the same amount of dose as a digital mammography acquisition of the same view. This feature is an iterative reconstruction algorithm that provides full-field digital mammography (FFDM)-like images and optimally impacts microcalcification conspicuity versus the traditional filtered back projection (FBP) algorithm.

SenoClaire, developed by GE Healthcare (Chalfont St. Giles, UK), improves the specificity of mammography by improving lesion margin visibility. Because of its low dose and non-inferior clinical accuracy, the system has the potential to replace digital mammography exams in screening at 50% the dose to help detect breast cancer. As part of the learning process, an additional craniocaudal (CC) view may be considered along with the 3D mediolateral-oblique (MLO) view, which will help radiologists become more comfortable with reviewing only the 3D MLO sequence in the near future.

SenoClaire enables better characterization of malignant and benign findings by providing a 3D MLO view that has superior detection for architectural distortions and masses compared with 2D FFDM. Clinical findings have shown that the recall rate after a 3D MLO examination is lower than the recall rate after a 2D FFDM exam.

The SenoClaire detector delivers high detective quantum efficiency (DQE) at low dose for visualizing microcalcifications without binning, a process that regroups pixels for faster readout speeds and improved signal-to-noise ratios, but with reduced image quality. The system’s step-and-shoot tube motion preserves microcalcification sharpness and avoids image blur, since the tube makes a total stop for each of the nine exposures. This provides higher peak contrast for microcalcifications than conventional continuous tube motion.

The SenoClaire grid in 3D, an antiscatter solution designed for tomosynthesis, reduces scattered radiation and improves detectability in 3D for breasts of above-average thickness, while preserving dose and performance.

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