Optical Imaging Fused with Tomosynthesis for Improved Breast Cancer

描述(由申请人提供)：本申请响应计划公告编号PAR-07-214(开发和验证活体成像系统和癌症研究方法的学术-产业界合作伙伴关系)，建议达特茅斯大学、马萨诸塞州大学医学院和霍洛奇公司(马萨诸塞州贝德福德)建立三方合作伙伴关系，开发和验证一种新的乳房成像融合技术-近红外(NIR)光谱断层扫描(NIRST)与乳房断层合成(BTS)相结合。我们的目标是创建一个单一的检查平台，将通过NIRST获得的功能参数与BTS提供的高分辨率3D结构信息协同结合起来，以实现表现出卓越的ROC特征和显著改进的PPV的诊断决策，而不是目前与乳腺癌监测相关的回电和诊断实践。该项目利用了其三个合作伙伴在技术、临床和商业方面的显著优势。具体地说，达特茅斯公司在开发NIRST在乳房成像中应用的先进概念方面拥有十多年的经验，包括已经成功地与其他传统成像方式融合的形式。达特茅斯公司还作为一家领先的机构参与了使用霍奇系统进行的BTS的早期临床研究。UMASS在乳房成像的X射线物理方面取得了成就和专业知识，其中包括在系统硬件以及图像处理和重建算法方面的重大进展，这些都是拟议研究的关键。霍洛奇公司是开发最先进的BTS技术的商业领先公司，在BTS评估性临床试验的设计和实施方面拥有丰富的经验，并准备将其第二代系统投入商业使用，预计该系统将在不久的将来获得FDA的批准。该项目的具体目标是：(1)开发NIRST和BTS的融合，发展到一个完全集成的平台，其中光学成像技术在BTS成像期间永久到位；(2)开发X射线图像分割和伴随重建算法，将乳房实质图案定义为近红外图像形成的结构先验；(3)优化和表征目标1和目标2最有希望的硬件和软件成果，并在体模和早期临床检查中对它们进行评估，以确定可行性，并以两个相同原型的形式改进它们的能力；(4)进行一项双中心临床研究，旨在证明所建议的融合平台的有效性，并建立该方法的临床潜力。与公众健康相关：屏幕胶片乳房X光摄影是检测乳腺癌的有效方法，也是唯一被证明可以降低乳腺癌死亡率的技术；然而，它的局限性是众所周知的，包括低灵敏度和阳性预测价值，主要是由于乳房X光照片中正常实质组织的重叠，特别是在致密的乳房。该拟议项目代表着三方学术-产业界合作伙伴关系，其目标是创建近红外(NR)光谱断层扫描(NIRST)与乳房断层合成(BTS)的创新融合，该融合已被证明(I)关于临床工作流程足够稳健，足以在双中心临床研究中部署，(Ii)其临床潜力得到验证，可增加单独使用BTS的诊断价值，以及(Iii)准备好进行规模更大的多中心评估性临床试验，足以产生获得FDA批准所需的数据。

DESCRIPTION (provided by applicant): This application responds to Program Announcement Number PAR-07-214 (Academic-Industrial Partnerships for Development and Validation of In Vivo Imaging Systems and Methods for Cancer Investigations) by proposing a 3-way partnership between Dartmouth, University of Massachusetts (UMass) Medical School and Hologic, Inc (Bedford, MA) to develop and validate a new fusion technology for breast imaging - Near Infrared (NIR) spectral tomography (NIRST) integrated with breast tomosynthesis (BTS). The goal is to create a single exam platform that will synergistically combine the functional parameters obtained through NIRST with the high resolution 3D structural information available from BTS to enable diagnostic decisions that exhibit superior ROC characteristics and substantially improved PPVs over current call-back and diagnostic practices associated with breast cancer surveillance. The project capitalizes on the significant technical, clinical and commercial strengths of its three partners. Specifically, Dartmouth provides more than a decade of experience in the development of advanced concepts for application of NIRST in breast imaging including forms that have been successfully fused with other conventional imaging modalities. Dartmouth has also participated as a leading institution in early clinical studies of BTS with the Hologic system. UMass brings accomplishments and expertise in the x-ray physics of breast imaging that includes the development of significant advances in system hardware as well as image processing and reconstruction algorithms which are pivotal to the proposed studies. Hologic, Inc, is the commercial leader in the development of the most advanced BTS technology, has extensive experience in the design and conduct of BTS evaluative clinical trials and is poised to release commercially its second generation system which is expected to gain FDA approval in the near future. The specific aims of the project are: (1) to develop a fusion of NIRST and BTS that progresses to a fully integrated platform where the optical imaging technology is permanently in place during BTS imaging; (2) to develop the x-ray image segmentation and concomitant reconstruction algorithms for defining breast parenchymal patterns as structural priors for NIR image formation; (3) to optimize and characterize the most promising hardware and software outcomes from Aim 1 and Aim 2 and evaluate them in phantoms and early-stage clinical exams to establish feasibility and refine their capabilities in the form of two identical prototypes; (4) to conduct a two- center clinical study designed to demonstrate the validity of the proposed fusion platform and establish the clinical potential of the approach. PUBLIC HEALTH RELEVANCE: Screen-film mammography is an effective method for detecting breast cancer and is the only technique proven to reduce mortality from the disease; however, its limitations are well known and include low sensitivity and positive predictive value, largely caused by the overlap of normal parenchymal tissues in the mammogram, especially in the dense breast. The goal of the proposed project, which represents a three-way academic- industrial partnership, is to create an innovative fusion of Near Infrared (NR) spectral tomography (NIRST) with breast tomosynthesis (BTS) that has been demonstrated to be (i) sufficiently robust with respect to clinical workflow to have been deployed in a two-center clinical study, (ii) validated in terms of its clinical potential to add diagnostic value over BTS alone and (iii) ready for much larger-scale multi-center evaluative clinical trials sufficient for generating the data required for gaining FDA approval.