Optical Imaging Fused with Tomosynthesis for Improved Breast Cancer

项目总结/摘要 本申请响应计划公告编号PAR-07-214（学术-工业合作伙伴关系 用于癌症研究的体内成像系统和方法的开发和验证）， 提议达特茅斯、马萨诸塞州大学医学院和 Hologic，Inc（贝德福德，马萨诸塞州）开发并验证用于乳腺成像的新融合技术-近红外 (NIR)光谱断层扫描（NIRST）与乳腺断层合成（BTS）相结合。我们的目标是创建一个单一的 考试平台，将通过NIRST获得的功能参数与高 BTS提供的高分辨率3D结构信息，使诊断决策具有上级 ROC特征和显著改善的PPV超过当前的回调和诊断实践 与乳腺癌监测有关。该项目利用了重要的技术，临床和 三个合作伙伴的商业优势。具体来说，达特茅斯提供了十多年的经验， 在开发NIRST在乳腺成像中应用的先进概念方面， 已成功与其他常规成像模式融合。达特茅斯也作为一个 使用Hologic系统进行BTS早期临床研究的领先机构。麻省大学带来了成就， 乳房成像的X射线物理学专业知识，包括以下方面的重大进展 系统硬件以及图像处理和重建算法，这是关键的建议 问题研究Hologic公司是最先进BTS技术开发的商业领导者， 在设计和进行BTS评价性临床试验方面拥有丰富的经验，并准备发布 第二代系统有望在不久的将来获得FDA的批准。的 该项目的具体目标是：（1）开发一种融合了近红外光谱技术和基站技术的系统，并逐步发展成为一种完全集成的系统， 在BTS成像期间，光学成像技术永久到位的平台;（2）开发 用于定义乳房实质图案的X射线图像分割和伴随的重建算法 作为NIR图像形成的结构先验;（3）优化和表征最有前途的硬件， 目标1和目标2的软件结果，并在体模和早期临床检查中对其进行评价， 建立可行性，并以两个相同原型的形式改进其能力;（4）进行两个- 中心临床研究，旨在证明所提出的融合平台的有效性，并建立 的临床潜力。

PROJECT SUMMARY/ABSTRACT 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.