Multimode laser optoacoustic tomography system for breast cancer care

描述(申请人提供)：“用于乳腺癌护理的多模激光光声断层成像系统”该项目的主要目标是通过开发一种基于光声断层扫描(OAT)和激光超声断层扫描(UST)生成5种不同图像的新型多模三维(3D)乳房成像仪来克服当前乳房成像方法的局限性。将OAT和激光UST结合到多模乳房成像方法中的原理是明确和令人信服的，因为OAT和UST分别作为有前景的乳腺癌成像方法受到了极大的关注。OAT可提供两种类型的图像：(1)与肿瘤血管生成密度相关的总血红蛋白图像和(2)血氧饱和度图像。这种与乳腺组织血液含量相关的功能(分子)信息可以帮助发现早期但侵袭性生长的乳腺肿瘤，这些肿瘤很难通过(X-射线)乳房X光检查发现，特别是在年轻女性放射致密的乳房。另一方面，UST可以基于三个互补的声学特性(1)声速(SOS)、(2)声衰减和(3)超声反射率提供高分辨率的乳腺病变解剖图像。通过将OAT和激光UST相结合，我们将建立一个成像系统，该系统可以提供全面的联合注册功能和解剖信息，而不需要乳房按压、电离辐射或造影剂。此外，使用激光产生超声波，我们将显著提高超声断层扫描的性能(灵敏度和分辨率)。我们的假设是，5个不同图像的共同配准和相关性，所提出的成像技术将提供最终的敏感性和特异性。在临床验证后，新的多模式3D成像技术将改变乳腺癌的治疗，不仅提供更好的筛查(检测)方法，而且将成为区分和表征乳腺肿瘤的高效工具，这一功能对于诊断和监测各种抗癌治疗的即时效果至关重要。在这个项目中，我们将开发技术(系统硬件和软件算法)，并在临床研究中测试这种多模式成像仪，这些患者患有疑似恶性肿瘤的小体积不可触及的乳腺肿瘤。该项目的具体目标是：(1)开发、制造和实施基于超宽带超声换能器旋转弧形阵列的光声加激光三维超声层析成像仪；(2)开发和评估用于所开发成像仪的稳健OAT图像重建方法；(3)开发用于所开发成像仪的三维超声和多模(OAT+UST)图像重建方法；以及(4)使用模仿乳房的体模和96名人类受试者对成像系统进行实验验证。该项目的成功完成将产生决定性的数据，以激励一项由FDA提供适当统计数据的系统性多中心研究，以评估所开发系统的有效性并确定全部临床适应症。

DESCRIPTION (provided by applicant): "Multimode Laser Optoacoustic Tomography System for Breast Cancer Care" The broad objective of the proposed project is to overcome the limitations of current breast imaging methods by developing a novel multimode three-dimensional (3D) breast imager that generates 5 different images based on optoacoustic tomography (OAT) and laser ultrasound tomography (UST). The rationale for combining OAT and laser UST into a multimode breast imaging method is clear and compelling, since both, OAT and UST are individually receiving significant attention as promising breast cancer imaging methods. OAT can provide two types of images: (1) image of the total hemoglobin associated with density of tumor angiogenesis and (2) image of blood oxygen saturation. This functional (molecular) information related to breast tissue blood content can help to detect early but aggressively growing breast tumors that are hard to detect with (x-ray) mammography, especially in radiologically dense breasts of younger women. On the other hand, UST can provide high-resolution anatomical images of breast lesions based on three complementary acoustic properties (1) speed-of-sound (SOS), (2) acoustic attenuation, and (3) ultrasound reflectivity. By combining OAT and laser UST we will establish an imaging system that can provide comprehensive co- registered functional and anatomical information without the need for breast compression, ionizing radiation, or contrast agents. Furthermore, using laser generation of ultrasound we will significantly improve performance (sensitivity and resolution) of the ultrasound tomography. Our hypothesis is that coregistration and correlation of 5 different images, the proposed imaging technology will provide ultimate sensitivity and specificity. When clinically validated, the new multimode 3D imaging technology will transform breast cancer care by providing not only a better screening (detection) method, but also will serve as a highly effective tool for differentiation and characterization of breast tumors, a feature critical for diagnostics and monitoring the immediate effects of various anticancer therapies. In this project, we will develop technology (system hardware and software algorithms) and test this multi-modality imager in clinical studies on patients present with small size non- palpable breast tumors suspicious for malignancy. The Specific Aims of the project are: (1) Develop, fabricate and implement an optoacoustic plus laser ultrasonic 3D tomography imager based on rotating arc-shaped array of ultrawide-band ultrasonic transducers, (2) Develop and evaluate robust OAT image reconstruction methods for use with the developed imager, (3) Develop 3D ultrasound and multimode (OAT+UST) image reconstruction methods for use with the developed imager, and (4) experimentally validate the imaging system using breast mimicking phantoms and 96 human subjects. The successful completion of the project will produce conclusive data to motivate a systematic multicenter appropriately statistically powered FDA-guided study to evaluate the effectiveness of the developed system and determine the full range of clinical indications.