Implementation of Digital Breast Tomosynthesis Into Clinical Practice


Acknowledgments

The authors thank Diana Frillici and Annette Wiebeld for their valuable input.

Introduction

The limitations of conventional digital mammography have been well established. Conventional mammography creates a two-dimensional (2D) image of a three-dimensional (3D) structure, which may result in superimposition of normal tissue and obscuration of lesions. This influences cancer detection and leads to high screening recall rates and false-positive findings. Conventional 2D mammography is particularly limited in dense breast tissue, and cancer detection is as low as 48% in women with extremely dense breast tissue.

Digital breast tomosynthesis is being increasingly adopted in breast imaging centers around the world, largely due to early clinical studies demonstrating this technology’s ability to address many of the limitations of conventional mammography. Due to improved diagnostic performance, it is expected that tomosynthesis will eventually become the standard of care in breast imaging facilities, and thus every facility will ultimately be faced with the task of incorporating the technology into practice. This presents a challenge, as to date there is limited guidance regarding how to best implement the technology, nor are there standard guidelines for the clinical use of tomosynthesis. In this chapter, we will discuss experience with the adoption and implementation of the tomosynthesis technology into the clinical practice setting, with perspectives from both a large private practice and a tertiary academic hospital setting.

Tomosynthesis Equipment

As of this writing, three manufacturers have received US Food and Drug Administration (FDA) approval for tomosynthesis use in the United States: Hologic Selenia Dimensions (2011), GE SenoClaire Digital Breast Tomosynthesis (2014) , and Siemens MAMMOMAT Inspiration with Tomosynthesis option (2015). These units all differ in their features, notably the angle of sweep, acquisition time, and receptor materials, as has been discussed in Chapter 2, Chapter 3 . Thorough investigation into the variations between manufacturers is advised prior to purchase of equipment to determine which unit best fits a facility’s needs.

Early Research With Tomosynthesis

For the early adopters, experience with tomosynthesis began by participating in research. Through such participation and using prototype machines, a few select sites were able to get early experience with the technology prior and leading to FDA approval for clinical use. At the current stage where tomosynthesis has entered the commercial sphere, facilities will now benefit from the knowledge acquired from this early research. The medical literature reporting on clinical experience with tomosynthesis is growing exponentially. Published literature can inform potential adopters of the benefits of the technology; however, each site will need to determine the optimal workflow and protocol for adopting tomosynthesis into their own practice.

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