Optical Imaging Fused with Tomosynthesis for Improved Breast Cancer

项目摘要/摘要 此应用程序响应计划公告编号PAR-07-214(学术-产业合作关系 用于癌症研究的体内成像系统和方法的开发和验证)由 提议达特茅斯大学、马萨诸塞大学医学院和 霍洛奇公司(马萨诸塞州贝德福德)将开发和验证一种用于乳房成像的新融合技术--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 考试平台，将NIRST获得的功能参数与HIGH协同结合 BTS提供的分辨率3D结构信息，以实现卓越的诊断决策 ROC特征和与当前回拨和诊断实践相比大幅改进的PPV 与乳腺癌监测有关。该项目利用了重要的技术、临床和 它的三个合作伙伴的商业优势。具体地说，达特茅斯提供了十多年的经验 在开发NIRST在乳房成像中应用的先进概念方面，包括具有 已经成功地与其他传统成像方式融合。达特茅斯还作为一名 在使用HOLOGIC系统进行BTS早期临床研究方面处于领先地位。大马士革大学带来成就和 在乳房成像的X射线物理方面的专门知识，包括在以下方面的重大进展 系统硬件以及图像处理和重建算法，这些算法对建议的 学习。霍洛奇公司是开发最先进的BTS技术的商业领导者，拥有 在BTS评估性临床试验的设计和实施方面拥有丰富的经验，并即将发布 在商业上，它的第二代系统预计将在不久的将来获得FDA的批准。这个 该项目的具体目标是：(1)开发NIRST和BTS的融合，进展到完全集成 在BTS成像期间光学成像技术永久到位的平台；(2)开发 用于确定乳腺实质模式的X射线图像分割和伴随重建算法 作为近红外成像的结构基础；(3)优化和表征最有前途的硬件和 目标1和目标2的软件结果，并在幻影和早期临床测试中对它们进行评估，以 以两个相同原型的形式确定可行性并提炼其能力；(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 该方法的临床应用潜力。

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.