Positive Results Following Evaluation of Tomosynthesis-Based 3T Mammography System

A newly developed tomosynthesis-based device is the world's first dedicated three-dimensional (3D) digital mammography system for the detection of breast cancer, the most common form of cancer found in women.

Xcounter, AB (Danderyd, Sweden), a developer of tomosynthesis-based 3D medical imaging, reported positive initial results from the first clinical evaluation of its innovative breast-screening device XC Mammo-3T prototype. Conducted in April 2009, the independent study by the mammography departments of Danderyd University Hospital (Stockholm, Sweden) and the Karolinska University Hospital (Stockholm, Sweden) evaluated the clinical benefits of using the new tomosynthesis-based 3D imaging compared with conventional 2D digital mammography. The study was based on 150 patients, each selected on the basis they required additional scanning due to suspicious lesions found during initial scans.

The results indicate that the XC Mammo-3T provides the same sensitivity from one tomosynthesis image compared to two images from 2D digital mammography, despite the fact that the patient selection was based on the 2D images by expert radiologists that currently have limited training in reading tomosynthesis images.

Dr. Gunilla Svane, associate professor of radiology at Karolinska University Hospital reported that the XC Mammo-3T prototype demonstrated a number of benefits over traditional 2D imaging, "One of the major limitations of 2D images is that it is difficult to discern individual features in dense breasts, which means that we may get false negative findings. The tomosynthesis technique makes each structure stand out in a way that makes it easier to detect tumors. In the 3D images, the extent of the feature is also more obvious, particularly for spiculated masses. Microcalcifications are as clearly visible in the XC Mammo-3T images as they are in 2D. In addition, it is easier to see the extension and the growth pattern of the calcifications in the three dimensional representation than in the 2D images where one is limited to two views.”

Dr. Edward Azavedo, associate professor of radiology at Karolinska University Hospital continued, "The ability of the XC Mammo-3T images to detect malignancy is just as high as the 2D images. However, the possibility to single out masked lesions in dense breasts also means that we will probably be able to detect more abnormalities and cancers in this category without additional examinations, such as ultrasound. The patient response has been very positive and the patients have stated that the 3D examination was much more comfortable than the regular 2D exam where amongst other things the compression force on the breast in general is higher.”

The findings from the independent clinical evaluation will be developed into a comprehensive clinical report during 2009.

Mikael Strindlund, CEO of Xcounter, said, "The positive results of our first prototype installation in a clinical environment is a major achievement for XCounter. I am particularly encouraged to hear that, unlike other imaging systems, XC Mammo-3T can confidently detect microcalcifications, helping to identify abnormalities earlier in their development.”

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Karolinska University Hospital