3D Hybrid Optoacoustic-Ultrasonic System for Diagnostic Imaging of Breast Cancer

用于乳腺癌诊断成像的 3D 混合光声超声系统

• 批准号: 8495494
• 负责人: ALEXANDER A ORAEVSKY
• 金额: $ 24.13万
• 依托单位: TOMOWAVE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-27 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8495494
• 关键词: Acoustics; Adjuvant; Amplifiers; Back; Benign; Blood; Breast; Breast Cancer Detection; Calibration; Cancer Patient; Cancerous; Carcinoma in Situ; Ceramics; Characteristics; Chemicals; Clinical; Clinical Research; Code; Communication; Computer software; Contracts; Coupling; Detection; Development; Devices; Diagnostic; Diagnostic Imaging; Dimensions; Electronics; Elements; Engineering; FDA approved; Frequencies; Functional Imaging; Funding; Future; Hemoglobin; Histocompatibility Testing; Hybrids; Image; Imagery; In Situ; Lasers; Lead; Magnetic Resonance Imaging; Malignant Neoplasms; Mammary Gland Parenchyma; Mammary Neoplasms; Mammography; Measurement; Mechanics; Medical; Medical Imaging; Methods; Microprocessor; Modality; Modeling; Molecular; Noise; Normal tissue morphology; Optics; Oxygen; PET/CT scan; Patients; Performance; Personal Computers; Phase; Physiologic pulse; Plant Resins; Polymers; Price; Process; Production; Relative (related person); Resolution; Roentgen Rays; Scanning; Shadowing (Histology); Shapes; Signal Transduction; Simulate; Slice; Small Business Innovation Research Grant; Specificity; Staging; System; Testing; Three-Dimensional Image; Time; Tissues; Transducers; Translations; Trust; Ultrasonic Transducer; Ultrasonics; Ultrasonography; Width; absorption; advanced system; analog; angiogenesis; antiangiogenesis therapy; base; computerized data processing; cost effective; data acquisition; data exchange; density; design; detector; digital; electric impedance; image reconstruction; imaging modality; lead titanate; lead titanate zirconate; malignant breast neoplasm; minimally invasive; new technology; novel; operation; optical imaging; performance tests; polyvinylidene fluoride; pressure; prototype; radiologist; research and development; research clinical testing; software development; tumor; two-dimensional

ABSTRACT ¿3D Hybrid Optoacoustic-Ultrasonic System for Diagnostic Imaging of Breast Cancer¿ The objective of this project is to develop a new advanced imaging system to allow visualization of small cancerous tumors in situ based on combination of two types of tissue contrast: (1) molecular contrast of deoxygenated hemoglobin associated with the function of aggressive malignancy to develop angiogenesis and consume oxygen and (2) structural contrast based on increased density of tumors relative to normal tissue. The functional contrast will be provided by the Laser Optoacoustic Imaging System (LOIS) and the structural contrast will be provided by ultrasound imaging. In the course of the two previous projects sponsored by NCI (R33CA095883, R44CA089959) we developed a clinical prototype of two-dimensional LOIS and performed feasibility testing in 36 breast cancer patients. The clinical results enabled the receipt of over $3 million in private funding for development of the commercial clinical system. On the other hand, our clinical studies showed that 3D optoacoustic imaging and correlation of LOIS with ultrasound, current FDA-approved adjuvant to X-ray mammography, will permit realization of the full diagnostic potential of the optoacoustic imaging and expedite radiologist¿s acceptance of LOIS as a clinical diagnostic imaging modality for breast cancer. Therefore, we propose a fast-track SBIR project to resolve technical issues associated with ultrawide-band ultrasonic transducers made of a novel piezoelectric ceramics (lead metaniobate), novel hardware, firmware and software that combines LOIS and USI systems, and finally, pilot clinical testing of the new system. The proposed 3D system will display 2D images of breast slices in real time and display the final 3D image upon execution of the translation scan along the axis along the laser beam and orthogonal to the slices. The operator will have an option of imaging in the optoacoustic mode, the ultrasound B mode or the combined mode correlating two types of tissue contrast, anatomical and functional. The present methods of medical imaging are only marginally successful in differentiating between cancerous and normal breast tumors. Optoacoustic imaging utilizes the highest known physical or chemical contrast of cancerous tissues relative to normal or benign tissue based on absorption of blood in the tumor microvessels and provides images with excellent resolution of 0.5 mm typical of ultrawide-band ultrasonic imaging. Novel PET/CT and 3D CT and MRI systems being developed do not provide real-time images and will have multimillion dollar price tags. We will utilize electronic hardware and software developed in the course of previous and ongoing R&D projects for development of a more advanced system for breast cancer. The focus of the Phase-I project will be on development, fabrication and testing of a single transducer elements capable of ultrawide-band ultrasound detection and emission of ultrasound pulses with no ringing. The Phase- II project will develop an arc-shaped linear array of novel transducers and its mechanical translation that simulates 2D array, modify firmware and software of the present system to enable dual modality operation and correlation of the two types of images, and test the system in phantoms followed by clinical evaluation in 12 patients with breast cancer. Successful accomplishment of the proposed project will motivate our investors to engage in the commercial development and the process of FDA approval.

摘要 用于乳腺癌诊断成像的三维光声-超声混合系统 该项目的目标是开发一种新的先进成像系统，以允许可视化 基于两种组织对比相结合的小癌原位肿瘤：(1)小肿瘤的分子对比 脱氧血红蛋白与侵袭性恶性肿瘤的血管生成和 消耗氧气和(2)基于相对于正常组织的肿瘤密度增加的结构对比。 功能对比度将由激光光声成像系统(LOIS)和结构 对比度将由超声成像提供。在NCI赞助的前两个项目的过程中 (R33CA095883，R44CA089959)我们开发了二维LOIS的临床原型，并进行了 对36例乳腺癌患者进行可行性检验。临床结果使超过300万美元的 为商业临床系统的开发提供私人资金。另一方面，我们的临床研究 显示LOIS的3D光声成像及其与目前FDA批准的佐剂超声的相关性 对于X射线乳房摄影，将允许充分实现光声成像的诊断潜力和 促使放射科医生S接受LOIS作为乳腺癌的临床诊断影像检查。 因此，我们提出了一个快速通道SBIR项目来解决与超宽带相关的技术问题 新型压电陶瓷(偏铌酸铅)超声换能器、新型硬件、固件 以及结合LOIS和USI系统的软件，最后是新系统的临床试验。这个 提出的3D系统将实时显示乳房切片的2D图像，并在 沿沿激光束且垂直于切片的轴线执行平移扫描。这个 操作员可以选择以光声模式、B超模式或组合模式进行成像 相关两种类型的组织对比的模式，解剖的和功能的。 目前的医学成像方法仅略微成功地区分了 癌性和正常的乳腺肿瘤。光声成像利用已知的最高物理或化学 基于肿瘤内血液吸收的癌组织与正常组织和良性组织的对比 微血管，提供超宽带超声典型的0.5 mm的出色分辨率的图像 成像。正在开发的新型PET/CT和3D CT和MRI系统不提供实时图像和 将会有数百万美元的价格标签。我们将利用课程中开发的电子硬件和软件 过去的和正在进行的研发项目，用于开发更先进的乳腺癌系统。这个 第一阶段项目的重点将是单个传感器元件的开发、制造和测试 能够在没有振铃的情况下进行超宽带超声检测和发射超声脉冲。阶段- II项目将开发一种新型换能器的弧形线性阵列及其机械平移 模拟2D阵列，修改本系统的固件和软件以实现双模式操作和 对比两种类型的图像，并在体模中测试系统，随后对12例进行临床评估 乳腺癌患者。拟议项目的成功完成将激励我们的投资者 参与商业开发和FDA审批流程。