One year after clinical trials began in Japan, Fujifilm Medical Systems USA, Inc. (Stamford, CT, USA) announced at the Radiological Society of North America (RSNA) 2011 annual meeting, held November 27-December 2, 2011, in Chicago (IL, USA), that clinical trials for their 3D digital mammography technology are about to begin in the United States. The medical imaging and informatics company is currently installing 3D mammography systems at medical centers in the United States with plans to begin trials as early as December 2011.
“When it comes to the early detection of breast cancer, radiologists will benefit from powerful 3D technology to elevate their diagnostic confidence using an average glandular dose that is equivalent to 2D full-field digital mammography [FFDM], increase their workflow, and give their patients improved outcomes,” explained David Hotchkiss, director of modality solutions marketing at Fujifilm. “After thorough evaluation of needs of the patients and clinicians, we believe that, when approved by the FDA [US Food and Drug Administration], Fujifilm’s 3D digital mammography has the potential to become the standard of care. We remain committed to improving our breast screening technologies, and we are confident that this will be the screening technology of choice.”
Fujifilm’s 3D digital mammography is currently commercially available for sale and in use in Europe. Because 3D digital mammography uses the similar clinical workflow as traditional FFDM, and because it presents the stereo images in a standard mammographic view of the breast that is familiar for radiologists, it has the potential to increase throughput and diagnostic confidence. The new 3D system will be especially powerful when viewing overlapping tissue, particularly in dense breasts, and will enable radiologists to better visualize abnormalities. This assertion is supported by a previous study of 3D stereo digital mammography at Emory University (Atlanta, GA, USA) that demonstrated a 23% increase in sensitivity, and a 46% decrease in patient callbacks.
According to Satoshi Arakawa, vice president of the medical systems division at Fujifilm Europe, “European clinicians are expressing increased enthusiastic interest in the 3D system. Initial reports of ongoing studies in Germany indicate that the low-dose 3D FFDM system has yielded statistically significant reduction in recall rates. These results are very encouraging. We hope to see many more clinics and patients benefit from this new 3D technology.”
Fujifilm is building upon its proven technological foundation for breast screening with its 3D digital mammography. Images will be acquired with the AspireHD Plus FFDM system upgraded with 3D capability that will combine the use of innovative Direct Optical Switching (DOS) detector technology and Fujifilm’s 50-micron resolution to generate the exceptional image quality and detailed visualization that is particularly vital for interpreting mammography studies. This 50-micron resolution is the foundation for Fujifilm’s entire breast imaging range, including its recently FDA-cleared Aspire HD and computed radiography (CR)-based FFDM. Fujifilm is the first manufacturer to provide an FDA-approved CR-based FFDM system in the United States, the scalable Aspire ClearView.
3D digital mammography is a works-in-progress and is not yet commercially available for sale in the United States. The Aspire HD Plus is known as Amulet f in other countries. It requires FDA clearance and is not yet commercially available for sale in the United States.
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