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: 7688775
• 负责人: ALEXANDER A ORAEVSKY
• 金额: $ 38.3万
• 依托单位: FAIRWAY MEDICAL TECHNOLOGIES, 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 2010-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7688775
• 关键词: Acoustics; Adjuvant; Amplifiers; Back; Benign; Blood; Blur; Breast; Breast Cancer Detection; Calibration; Cancer Patient; Cancerous; Ceramics; Characteristics; Chemicals; Class; Clinical; Clinical Research; Code; Communication; Computer software; Contracts; Coupling; Data; Detection; Development; Devices; Diagnostic; Diagnostic Imaging; Dimensions; Electronics; Elements; Engineering; Frequencies; Functional Imaging; Funding; Future; Hand; Hemoglobin; Histocompatibility Testing; Hybrids; Image; Imagery; In Situ; Invasive; 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; Operative Surgical Procedures; Optics; Oxygen; PET/CT scan; Patients; Performance; Personal Computers; Phase; Physiologic pulse; Plant Resins; Polymers; Price; Process; Production; Pulse taking; Purpose; Range; Relative (related person); Resolution; Roentgen Rays; Scanning; Shadowing (Histology); Shapes; Signal Transduction; Simulate; Slice; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Specificity; Staging; System; Testing; Three-Dimensional Image; Three-Dimensional Imaging; Time; Tissues; Transducers; Translations; Trust; Ultrasonic Transducer; Ultrasonics; Ultrasonography; United States Food and Drug Administration; Width; absorption; abstracting; advanced system; analog; angiogenesis; antiangiogenesis therapy; base; computerized data processing; concept; cost effective; data acquisition; density; design; detector; digital; electric impedance; image reconstruction; lead titanate; lead titanate zirconate; malignant breast neoplasm; new technology; novel; optical imaging; performance tests; polyvinylidene fluoride; pressure; prototype; radiologist; research and development; research clinical testing; size; software development; transmission process; tumor; two-dimensional

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：该项目的目标是开发一种新的先进成像系统，基于两种类型的组织对比的组合，能够在原位可视化小型癌性肿瘤：（1）与脱氧血红蛋白相关的分子对比侵袭性恶性肿瘤发展血管生成和消耗氧气的功能；（2）基于肿瘤相对于正常组织密度增加的结构对比。功能对比将由激光光声成像系统（LOIS）提供，结构对比将由超声成像提供。在 NCI 赞助的前两个项目（R33CA095883、R44CA089959）过程中，我们开发了二维 LOIS 的临床原型，并在 36 名乳腺癌患者中进行了可行性测试。临床结果使我们获得了超过 300 万美元的私人资金，用于商业临床系统的开发。另一方面，我们的临床研究表明，3D 光声成像以及 LOIS 与超声的相关性（目前 FDA 批准的 X 射线乳房 X 线摄影辅助手段）将能够实现光声成像的全部诊断潜力，并加快放射科医生对 LOIS 的接受。乳腺癌的临床诊断成像方式。因此，我们提出了一个快速 SBIR 项目，以解决与由新型压电陶瓷（偏铌酸铅）制成的超宽带超声换能器、结合 LOIS 和 USI 系统的新型硬件、固件和软件相关的技术问题，最后进行试点临床新系统的测试。所提出的 3D 系统将实时显示乳房切片的 2D 图像，并在沿激光束轴执行平移扫描并与切片正交时显示最终的 3D 图像。操作员可以选择在光声模式、超声 B 模式或与两种类型的组织对比（解剖和功能）相关的组合模式下进行成像。目前的医学成像方法在区分癌性乳腺肿瘤和正常乳腺肿瘤方面仅取得了一定程度的成功。光声成像基于肿瘤微血管中的血液吸收，利用癌组织相对于正常或良性组织的已知最高物理或化学对比度，并提供具有超宽带超声成像典型的 0.5 毫米高分辨率的图像。正在开发的新型 PET/CT 和 3D CT 以及 MRI 系统不提供实时图像，并且价格高达数百万美元。我们将利用之前和正在进行的研发项目中开发的电子硬件和软件来开发更先进的乳腺癌系统。第一阶段项目的重点将是开发、制造和测试单个换能器元件，该换能器元件能够进行超宽带超声检测并发射无振铃的超声脉冲。第二阶段项目将开发新型换能器的弧形线性阵列及其模拟二维阵列的机械平移，修改现有系统的固件和软件以实现双模态操作和两种类型图像的关联，并测试模型中的系统随后对 12 名乳腺癌患者进行了临床评估。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 批准过程。