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

基本信息

批准号：
7272931
负责人：
ALEXANDER A ORAEVSKY
金额：
$ 14.86万
依托单位：
FAIRWAY MEDICAL TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-27 至 2008-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7272931
关键词：
Acoustics Adjuvant Amplifiers Area Arteries Back Benign Biopsy Blood Blur Breast Breast Cancer Detection Caliber Calibration Cancer Patient Cancerous Ceramics Characteristics Chemicals Chest wall structure Class Clinical Clinical Research Code Color Communication Computer Simulation Computer software Computers Contracts Country of Turkey Coupling Data Depth Detection Development Devices Diagnostic Diagnostic Imaging Diagnostic Specificity Dimensions Dyes Early Diagnosis Electronics Elements Engineering Evaluation Feasibility Studies Freezing Frequencies Functional Imaging Funding Future Gelatin Generations Hand Hemoglobin Histocompatibility Testing Human Hybrids Hypoxia Image Image Analysis Image Enhancement Imagery Imaging technology In Situ In Vitro Individual Invasive Lasers Lead Lesion Light Lighting Liver Location Magnetic Resonance Imaging Malignant Neoplasms Mammary Gland Parenchyma Mammary Neoplasms Mammography Maps Measurement Measures Mechanics Medical Medical Imaging Methods Microprocessor Milk Modality Modeling Molecular Muscle Nipples Noise Noninfiltrating Intraductal Carcinoma Normal tissue morphology Numbers Operative Surgical Procedures Optics Oxygen PET/CT scan Patients Performance Personal Computers Phase Physiologic pulse Plant Resins Plasticizers Polyethylene Polyethylenes Polymers Polyvinyl Alcohol Polyvinyl Chloride Positron-Emission Tomography Preparation Price Process Production Property Pulse taking Purpose Range Recommendation Relative (related person)Resolution Roentgen Rays Safety Scanning Shadowing (Histology)Shapes Signal Transduction Simulate Slice Small Business Funding Mechanisms Small Business Innovation Research Grant Solutions Specificity Speed Staging Structure Sum Surface Surgical Flaps System Testing Three-Dimensional Image Three-Dimensional Imaging Time Tissues Transducers Translations Trust Tumor Angiogenesis Ultrasonic Transducer Ultrasonics Ultrasonography United States Food and Drug Administration Variant Veins Weight Width absorption advanced system analog angiogenesis antiangiogenesis therapy attenuation base beef computerized data processing concept cost effective data acquisition density design detector digital electric impedance experience image processing image reconstruction in vivo lead titanate lead titanate zirconate lens malignant breast neoplasm new technology novel optical imaging performance tests polyvinylidene fluoride pressure prototype radiologist research and development research clinical testing size software development sound success therapeutic angiogenesis tissue phantom transmission process trend tumor two-dimensional

项目摘要

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）：该项目的目的是开发一种新的高级成像系统，以基于两种类型的组织对比的组合来可视化小癌性肿瘤的原位：（1）与积极恶性肿瘤的功能相关的脱氧血红蛋白的分子对比，以形成型和（综合型结构对比造成型和（2）对构造的相对性增强的肿瘤相对症状，并增加了肿瘤的造型。功能对比度将由激光光声成像系统（LOI）提供，结构对比度将由超声成像提供。在前一个由NCI（R33CA095883，R44CA089959）赞助的两个项目中，我们开发了二维路易斯的临床原型，并对36名乳腺癌患者进行了可行性测试。临床结果使得商业临床系统的开发获得了超过300万美元的私人资金。另一方面，我们的临床研究表明，LOIS与超声，当前FDA批准的佐剂与X射线乳房X线摄影的超声相关性和相关性，将允许实现光声成像的全部诊断潜力，而快速放射科医生对Lois对临床诊断诊断为乳腺成像模式的接受。因此，我们提出了一个快速轨道SBIR项目，以解决与由新型的压电陶瓷（铅元素obate）制成的超级波段超声传感器相关的技术问题，新型硬件，固件和软件结合了LOIS和USI系统，最后是新系统的飞行员临床测试。提出的3D系统将实时显示胸切片的2D图像，并在沿激光束沿轴沿轴进行扫描时，显示最终的3D图像，并与切片正交正交。操作员将在光声模式，超声B模式或组合模式下进行成像的选项，该模式将两种类型的组织对比度（解剖学和功能）相关联。目前的医学成像方法仅在区分癌性和正常乳腺肿瘤方面略有成功。基于肿瘤微血管中血液的吸收，光声成像利用了癌组织相对于正常或良性组织的最高已知的物理或化学对比度，并提供具有超速频带超声超声成像的0.5 mm典型分辨率的图像。开发的新型PET/CT和3D CT和MRI系统不会提供实时图像，并且具有数百万美元的价格标签。我们将利用在以前和正在进行的研发项目过程中开发的电子硬件和软件来开发更先进的乳腺癌系统。 I期项目的重点将放在能够超声波超声检测和发射超声脉冲的单个传感器元件的开发，制造和测试上，没有响铃。第II期项目将开发出新型传感器的弧形线性阵列及其机械翻译，以模拟2D阵列，修改本系统的固件和软件，以实现两种类型的图像的双模态操作和相关性，并在幻象中测试系统中的系统，然后在12例乳腺癌患者中进行临床评估。拟议项目的成功完成将激发我们的投资者参与商业开发和FDA批准的过程。