Integrated 3D Xray and Dynamic Tomographic Optical Breast Imaging System

描述（由申请人提供）：除皮肤癌外，乳腺癌仍然是影响女性人口的最常见癌症，也是第二大致命癌症（仅次于肺癌）。根据美国癌症协会的数据，仅在2008年，就有超过182 000名妇女被新诊断出患有这种疾病，近41 000人将死于这种疾病。虽然通过乳房X光检查及早发现已开始影响死亡率，但乳房X光检查在年轻妇女和乳房致密妇女中的灵敏度仍然较低，假阳性率也很高。近年来，断层光学乳腺成像（TOBI）在提供组织功能信息以补充由已建立的医学成像模式提供的结构图像方面取得了有希望的进展。特别是，我们的小组已经开发出一种组合的光学/X射线断层合成装置，并从有限的临床试验中获得了有希望的初步结果，其中观察到总血红蛋白对比度可以区分恶性和良性病变以及正常组织。此外，我们观察到乳房X线摄影压缩引起乳房组织光学特性的时间变化，并发现这些变化可用于计算组织耗氧量和血流量，以及携带有关各种组织区域生物力学特性的内在信息。受这些初步结果的鼓舞，我们建议，响应PAR-07-214，开发一种临床系统，该系统将高时间分辨率TOBI与任何商业乳腺X射线摄影或断层合成设备集成，能够通过采用X射线半透明材料作为光学患者界面，同时采集X射线和时间分辨光学图像。这种系统的开发将允许进行I期临床试验，其中可以评估光学静态，动态和代谢标记物的诊断性能，以收集必要的统计信息来计划II期有效性试验。利用长期的合作关系，该提案汇集了博厄斯博士的团队，领先的光学技术和算法开发，TechEn公司，一家在构建交钥匙光学成像系统方面拥有丰富经验的定制工程公司，以及数字乳腺断层合成摄影的先驱Kopans博士的临床小组。TechEn将与Boas博士的团队密切合作，构建动态光学成像系统的商业级原型，并与Kopans博士合作，该系统将在进行乳腺癌筛查的女性中进行临床测试以及后续诊断，目标是微调临床操作程序并完善仪器，以及收集关于光学组织参数的诊断价值及其增强X射线断层合成的灵敏度和特异性的能力的初始数据。

DESCRIPTION (provided by applicant): Excluding cancers of the skin, breast cancer remains the most common cancer affecting the female population, and the second most deadly (behind lung cancer). In 2008 alone, over 182,000 women will have been newly diagnosed and nearly 41,000 will have died of this disease according to the American Cancer Society. While early detection through X-ray mammographic screening is starting to impact mortality rates, mammography still suffers from reduced sensitivity in younger women and women with dense breasts and from a significant false positive rate. In recent years tomographic optical breast imaging (TOBI) has made promising advances in providing tissue functional information to complement the structural images offered by established medical imaging modalities. In particular, our group has developed a combined optical/x-ray tomosynthesis device and obtained promising initial results from a limited clinical trial, where total hemoglobin contrast was observed to discriminate between malignant and benign lesions and normal tissue. Additionally, we observed that mammographic compression induces temporal changes in breast tissue optical properties and discovered that these variations may be used to calculate tissue oxygen consumption and blood flow, as well as carrying intrinsic information about the biomechanical properties of various tissue regions. Encouraged by these initial results we propose, in response to PAR-07-214, to develop a clinical system that integrates high temporal resolution TOBI with any commercial mammography or tomosynthesis device with the ability to acquire simultaneous x-ray and time-resolved optical images by employing x-ray translucent materials for the optical patient interface. The development of such a system will allow the performance of Phase I clinical trials in which the diagnostic performance of optical static, dynamic and metabolic markers can be evaluated to gather the necessary statistical information to plan a Phase II effectiveness trial. Leveraging long standing relationships, this proposal brings together the team of Dr. Boas, leading optical technology and algorithm development, TechEn Inc., a custom engineering company with substantial experience building turn-key optical imaging systems, and the clinical group of Dr. Kopans, a pioneer in the development of digital breast tomosynthesis. TechEn, in close collaboration with Dr. Boas' group will construct a commercial grade prototype of the dynamic optical imaging system and in collaboration with Dr. Kopans the system will be clinically tested on women presenting for breast cancer screening as well as for follow-up diagnosis with the goal of fine tuning clinical operating procedure and refining the instrumentation, as well as gathering initial data on the diagnostic value of optical tissue parameters, and their ability to enhance the sensitivity and specificity of x-ray tomosynthesis.