A versatile high-performance optical mammography co-imager

 描述(申请人提供)：X光乳房X光摄影有助于降低乳腺癌的死亡率。然而，它本身就受到限制，因为它无法直接观察与癌组织功能相关的生理信息。这最终限制了X光乳房X光检查的特异性和预后能力。漫反射光学断层扫描(DOT)是一种很有前途的成像方式，它提供了关于血管生成和血红蛋白氧饱和度的信息-与癌症的存在和演变有关的关键参数。然而，由于光学耦合变化，它受到空间分辨率有限和图像质量不令人满意的影响。这些限制阻碍了对光学图像的直接解释 获得了广泛的DOT临床验证。这一障碍可以通过在多模式成像配置中协同地融合光学和X射线信息来克服- 也就是说，通过将这两种方法结合起来，我们可以克服它们各自的局限性，实现一种新的具有更高特异性和预后价值的多模式成像方法。基于我们与飞利浦Healthcare的成功初步合作和强大的初步数据，我们建议通过开发独立于供应商的高性能光学乳房X光摄影联合成像仪(OMCI)，从根本上解决目前X光乳房X光检查的临床局限性，使用来自单独获取的2D或3D数字乳房X光X光照片的结构指导，使用OMCI联合重建光学测量。我们认为，从临床翻译的角度来看，这种方法具有显著的优势，因为它直接 利用美国安装的9000多个数字乳房X光检查系统，预计将与未来几代乳房X光扫描扫描仪兼容。建议的方法将大大减少与开发和部署集成光学/乳房X光成像系统相关的时间延迟、成本和复杂的监管路径。在拟议的研究中，我们将为活体传输的人体成像构建一个新的DOT系统架构，并开发创新的先验引导重建算法，以利用高密度光学测量，显著提高光学图像的分辨率和质量。在一个强大的临床团队的支持下，我们将进行一项临床研究，以探索使用该系统检测恶性病变的敏感性和特异性。我们将通过盲法研究系统地比较OMCI辅助的乳房X光检查诊断和独立的乳房X光检查，以进一步确认增加的功能信息的临床价值。这一结果将为我们未来的多中心试验和监管部门对这种新设备的批准做好准备。

 DESCRIPTION (provided by applicant): X-ray mammography has contributed to a reduction in mortality due to breast cancer. It is inherently limited, though, by its inability to directly observe physiological information relevant to the function of cancerous tissue. This ultimately limits the specificity and prognostic ability of x-ray mammography. Diffuse optical tomography (DOT) is a promising imaging modality that provides information on angiogenesis and hemoglobin oxygen saturation - key parameters tied to the presence and evolution of cancer. It suffers, however, from limited spatial resolution and unsatisfactory image quality due to optical coupling variations. These limitations inhibit straightforward interpretation of the optical images obtained and widespread clinical validation of DOT. This obstacle can be overcome by synergistically "fusing" the optical and x-ray information in a multi-modal imaging configuration - that is, by combining the two modalities, we can overcome their respective limitations and achieve a new multi-modality imaging method with enhanced specificity and prognostic value. Building upon our successful initial collaboration with Philips Healthcare and strong preliminary data, we propose to fundamentally address the current clinical limitations in x-ray mammography by developing a vendor- independent high-performance optical mammography co-imager, or OMCI, with which the optical measurements can be jointly reconstructed using the structural guidance from a separately acquired 2D or 3D digital x-ray mammogram. We believe that this approach has significant advantage from a clinical translation standpoint, as it directly capitalizes on the over 9,000 installed digital mammography systems in the US, and is expected to be compatible with future generations of mammography scanners. The proposed approach will dramatically reduce the time delays, costs, and complex regulatory pathways associated with developing and deploying integrated optical/mammography imaging systems. In the proposed study, we will build a new DOT system architecture for in vivo transmission human imaging and develop innovative prior-guided reconstruction algorithms to utilize high-density optical measurements and significantly enhance the optical image resolution and quality. Supported by a strong clinical team, we will perform a clinical study to explore the sensitivity an specificity of detecting malignant lesions using the proposed system. We will systematically compare the OMCI-assisted mammography diagnosis with stand-alone mammography through a blinded reader study to further confirm the clinical value of the added functional information. This result will prepare us for future multi- center trials and regulatory approval for this new device.