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

传统的x射线乳房x线照相术能很好地显示一些患者的乳腺癌；然而，许多高危患者的乳腺组织致密，类似于乳房x光摄影图像中的癌变灶。此外，x射线成像只能捕捉组织解剖结构，而不能捕捉功能，这使得辨别肿瘤是否对治疗有反应变得更加困难。正电子发射乳房x线摄影（PEM）有能力解决x线乳房x线摄影的这两个缺点。PEM利用肿瘤代谢来显示乳腺中活动增加的区域，与乳腺密度无关。PEM的另一个特点是，与传统的乳房x光检查相比，它不需要痛苦的乳房压迫。然而，PEM确实需要使用注射放射性示踪剂，我们的技术创新专注于开发世界上最敏感的临床核成像系统，以便减少放射性示踪剂的剂量。我们的目标是将高性能PEM系统推向市场，该系统的操作剂量仅为通用全身正电子发射断层扫描（PET）扫描仪的一小部分。我们将使用固态光电倍增管的无缝阵列，而不是竞争对手Naviscan系统使用的真空管扫描线。Radialis Medical是湖首大学和桑德贝地区健康研究所的合资企业，将与我们合作将这项创新技术商业化，并在桑德贝组装加拿大第一个分子乳房成像系统。临床原型将用于收集上市许可和临床使用所需的监管提交所需的数据。我们技术的临床应用将提高乳腺癌患者的生存率，并产生显著的临床（和经济）效益。此外，本文提出的技术进步将降低质子交换膜装置的制造成本，促进其在加拿大和世界范围内的广泛使用，从而对加拿大人的健康产生积极影响。

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.