Multimode laser optoacoustic tomography system for breast cancer care

描述（由申请人提供）：“用于乳腺癌护理的多模激光光声断层扫描系统”拟议项目的总体目标是通过开发一种新型多模三维（3D）乳房成像仪来克服当前乳房成像方法的局限性，该乳房成像仪基于光声断层扫描（OAT）和激光超声断层扫描（UST）产生5种不同的图像。将OAT和激光UST结合成一种多模式乳腺成像方法的基本原理是明确和令人信服的，因为OAT和UST都作为有前途的乳腺癌成像方法受到了极大的关注。OAT可以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的、恶性生长的乳腺肿瘤，这些肿瘤很难用x线乳房x光检查发现，特别是在年轻女性的致密乳房中。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)超声反射率提供乳腺病变的高分辨率解剖图像。通过结合OAT和激光UST，我们将建立一个成像系统，可以提供全面的功能和解剖信息，而不需要乳房压迫，电离辐射或造影剂。此外，利用激光产生超声，我们将显著提高超声层析成像的性能（灵敏度和分辨率）。我们的假设是5张不同图像的共配准和相关，所提出的成像技术将提供最终的灵敏度和特异性。当临床验证时，新的多模式3D成像技术将改变乳腺癌护理，不仅提供更好的筛查（检测）方法，而且还将作为乳腺肿瘤鉴别和表征的高效工具，这是诊断和监测各种抗癌治疗的即时效果的关键功能。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态成像仪，以检测怀疑为恶性的小尺寸不可触及的乳房肿瘤。该项目的具体目标是：(1)开发、制造和实现基于超宽带超声换能器旋转电弧阵列的光声+激光超声三维断层成像成像仪；(2)开发和评估用于所开发成像仪的鲁棒OAT图像重建方法；(3)开发用于所开发成像仪的3D超声和多模（OAT+UST）图像重建方法；(4)使用乳房模拟模型和96名人体受试者实验验证成像系统。该项目的成功完成将产生结论性数据，以激励一项系统的多中心研究，以适当的统计支持fda指导，以评估开发系统的有效性并确定临床适应症的全部范围。

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.