Advances technology for positron emission mammography - market-ready prototype (phase IIb)

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Conventional X-ray mammography visualizes breast cancer well for some patients; however, many high-risk patients have dense breast tissue that resembles cancerous lesions in mammography images. Also, X-ray imaging only captures tissue anatomy, not function, making it more difficult to discern whether tumours are responding to treatment. Positron Emission Mammography (PEM) has the ability to address both of these shortcomings of X-ray mammography. PEM uses tumour metabolism to visualize areas of increased activity in the breast independent of breast density. An additional feature of PEM is that, in contrast to conventional mammography, it does not require painful breast compression. However, PEM does require the use of an injected radiotracer and our technical innovations have focused on developing the world's most sensitive clinical nuclear imaging system so that the dose of radiotracer can be reduced. Our goal is to bring to market a high performance PEM system that operates at a fraction of the dose of general purpose whole-body Positron Emission Tomography (PET) scanners. We will be using a seamless array of solid-state photomultipliers as opposed to a scanning line of vacuum tubes used by the competitive Naviscan system. Radialis Medical, a joint venture between Lakehead University and the Thunder Bay Regional Health Research Institute, will be partnering with us to commercialize this innovative technology and assemble the first Canadian molecular breast imaging system in Thunder Bay. The clinical prototype will be used to collect the data necessary for regulatory submissions required for marketing clearance and clinical use. Clinical implementation of our technology will result in an improvement of breast cancer survival and yield significant clinical (and economic) benefits. Furthermore, the technological advances proposed here will reduce manufacturing cost for PEM devices facilitating their wide-spread use in Canada and world-wide, thus positively influencing the health of Canadians.