Dr. Levine is the lead investigator of a tomosynthesis trial now underway at the Hoag Breast Care Center.

"At our site, we are going to recruit 450 patients," says Dr. Levine. "In one arm of the study we are looking at screening patients, and in another we are looking at patients that are undergoing biopsy."



The trial started in February and will last approximately 18 months.

Hologic's Selenia Dimensions 2D system, which is currently on the market, can be configured to support 3D breast imaging when and if the FDA approves tomosynthesis. The company also manufactures a 2D/3D system, which is exclusively available in Europe at this time.

"We have sold over 50 commercial tomosynthesis systems outside of the U.S. and feedback from those customers is very positive," says Pat Hall. Customers find the system to be very user-friendly and like the ability to visualize the breast in 1 millimeter slices, eliminating diagnostic difficulties associated with overlapping breast tissue."

Hologic is engaged in ongoing discussions with the FDA regarding the approval of its tomosynthesis technology.

In the near future, FUJIFILM Medical Systems hopes to bring "Avatar" technology to a breast imaging site near you. The manufacturer is working on its own version of advanced 3D technology, a product so new that it does not even have a name yet.

"3D is really blossoming right now in the entertainment and gaming industry and there are all types of interesting hardware that are being developed," says Vandergrift. "These hardware developments will allow us to introduce our software that will then result in radiologists sitting in front of a work station where they can then view 3D mammograms."

FUJIFILM Medical's mammography technology has the potential to rival tomosynthesis in imaging a 3D view of the breast. To interpret the image in 3D, the radiologist will wear a set of polarized glasses while examining the picture at the workstation.

"The way our 3D mammography system works is that we only take two views of the breast, where tomosynthesis takes multiple views, as many as 11 to 15," says Vandergrift. "At any given time, the tomosynthesis image is displayed in 2D, you can't see an entire presentation of a 3D breast. You can see it in a video clip or you can see it in slices but you cannot see the entire breast presented in one time. With our approach, you can," he says.

The manufacturer plans to begin case collection for the 3D technology in Europe soon. Its Aspire HD FFDM system is currently undergoing clinical trials in the U.S. Upon approval of both technologies, the company envisions offering a 3D mammography upgrade for its Aspire HD unit.

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