GE Healthcare (GE), is planning to complete the clinical trial entitled “Radiologists' Preference Study - Digital Breast Tomosynthesis” for Digital Breast Tomosynthesis System by October 2009. The trial is currently recruiting participants. The study objective to compare radiologist impression of digital breast tomosynthesis to digital mammography with respect to their ability to see and characterize specific lesion features.
The non-randomized, open label, single group assignment trial is conducted in US with an estimated enrollment of 50 participants. The Principal Investigators for the study are Amy S Campbell, MD from University of South Carolina and Etta D Pisano, MD from The University of North Carolina, Chapel Hill.
Digital Breast Tomosynthesis System performs 3-D X-ray mammography at a dose similar to the conventional 2-D X-ray mammography. It takes multiple X-ray pictures of each breast from many angles. The images will be reconstructed into a 3-D series of these high-resolution slices that can be viewed individually or in a cine loop. Unlike conventional 2-D projection mammography, this system reduces the tissue overlap and structure noise. Tomosynthesis enables higher degree of breast care by allowing to fuse that information with other 3-D data, such as ultrasound MR (Magnetic Resonance) or optical imaging to provide more complete information for an accurate diagnosis.