Integrated 3D Xray and Dynamic Tomographic Optical Breast Imaging System

集成 3D X 射线和动态断层光学乳腺成像系统

• 批准号: 8210875
• 负责人: David A Boas
• 金额: $ 58.07万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-02-01 至 2015-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8210875
• 关键词: Accounting; Adipose tissue; Affect; Algorithms; American Cancer Society; Anxiety; Benign; Biological Markers; Biomechanics; Biopsy; Blood flow; Boa; Breast; Breast Cancer Detection; Clinical; Clinical Research; Clinical Trials; Collaborations; Complement; Custom; Cyst; Data; Development; Devices; Diagnosis; Diagnostic; Diagnostic Neoplasm Staging; Diagnostic radiologic examination; Digital Mammography; Digital X-Ray; Disease; Early Diagnosis; Engineering; Evolution; Female; Fiber Optics; Functional Imaging; Goals; Health; Health Care Costs; Hemoglobin; Image; Imaging Techniques; Imaging technology; Lesion; Letters; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of lung; Mammary Gland Parenchyma; Mammography; Measurement; Measures; Mechanics; Medical Imaging; Metabolic; Metabolic Marker; Newly Diagnosed; Normal tissue morphology; Optics; Oxygen Consumption; Patients; Performance; Phase; Phase I Clinical Trials; Population; Positioning Attribute; Positron-Emission Tomography; Procedures; Process; Property; Resolution; Roentgen Rays; Screening procedure; Sensitivity and Specificity; Skin Cancer; Specificity; System; Technology; Testing; Time; Tissues; Variant; Woman; angiogenesis; breast cancer diagnosis; calcification; digital; effectiveness trial; experience; follow-up; image reconstruction; imaging modality; improved; instrumentation; interest; malignant breast neoplasm; mortality; optical imaging; prognostic; prototype; public health relevance; response

DESCRIPTION (provided by applicant): Excluding cancers of the skin, breast cancer remains the most common cancer affecting the female population, and the second most deadly (behind lung cancer). In 2008 alone, over 182,000 women will have been newly diagnosed and nearly 41,000 will have died of this disease according to the American Cancer Society. While early detection through X-ray mammographic screening is starting to impact mortality rates, mammography still suffers from reduced sensitivity in younger women and women with dense breasts and from a significant false positive rate. In recent years tomographic optical breast imaging (TOBI) has made promising advances in providing tissue functional information to complement the structural images offered by established medical imaging modalities. In particular, our group has developed a combined optical/x-ray tomosynthesis device and obtained promising initial results from a limited clinical trial, where total hemoglobin contrast was observed to discriminate between malignant and benign lesions and normal tissue. Additionally, we observed that mammographic compression induces temporal changes in breast tissue optical properties and discovered that these variations may be used to calculate tissue oxygen consumption and blood flow, as well as carrying intrinsic information about the biomechanical properties of various tissue regions. Encouraged by these initial results we propose, in response to PAR-07-214, to develop a clinical system that integrates high temporal resolution TOBI with any commercial mammography or tomosynthesis device with the ability to acquire simultaneous x-ray and time-resolved optical images by employing x-ray translucent materials for the optical patient interface. The development of such a system will allow the performance of Phase I clinical trials in which the diagnostic performance of optical static, dynamic and metabolic markers can be evaluated to gather the necessary statistical information to plan a Phase II effectiveness trial. Leveraging long standing relationships, this proposal brings together the team of Dr. Boas, leading optical technology and algorithm development, TechEn Inc., a custom engineering company with substantial experience building turn-key optical imaging systems, and the clinical group of Dr. Kopans, a pioneer in the development of digital breast tomosynthesis. TechEn, in close collaboration with Dr. Boas' group will construct a commercial grade prototype of the dynamic optical imaging system and in collaboration with Dr. Kopans the system will be clinically tested on women presenting for breast cancer screening as well as for follow-up diagnosis with the goal of fine tuning clinical operating procedure and refining the instrumentation, as well as gathering initial data on the diagnostic value of optical tissue parameters, and their ability to enhance the sensitivity and specificity of x-ray tomosynthesis. Public health relevance: development of optical cancer markers may improve sensitivity of x- ray mammography, leading to fewer missed early stage cancers; at the same time, improvements in specificity may decrease the number of un-necessary biopsies, thus reducing both patient anxiety and health care costs. PUBLIC HEALTH RELEVANCE: Development of optical cancer markers may improve sensitivity of x-ray mammography, leading to fewer missed early stage cancers; at the same time, improvements in specificity may decrease the number of un-necessary biopsies, thus reducing both patient anxiety and health care costs.

描述（由申请人提供）：不包括皮肤的癌症，乳腺癌仍然是影响女性人群的最常见癌症，第二个最致命的癌症（仅次于肺癌）。仅在2008年，仅在2008年，就新诊断出了182,000多名妇女，根据美国癌症学会的数据，将有近41,000名妇女死于这种疾病。虽然通过X射线乳房X线摄影筛查的早期检测开始影响死亡率，但乳房X线摄影仍然遭受着乳房密集的年轻妇女和妇女的敏感性降低，并且由于明显的假阳性率降低。近年来，断层扫描光学乳房成像（TOBI）在提供组织功能信息方面取得了令人鼓舞的进步，以补充已建立的医学成像方式提供的结构图像。特别是，我们的小组已经开发了一种合并的光学/X射线间歇合成装置，并获得了有限的临床试验的有希望的初始结果，在该试验中，观察到总血红蛋白对比度可以区分恶性病变和良性病变和正常组织。此外，我们观察到乳房X线学压缩会引起乳腺组织光学特性的时间变化，并发现这些变化可用于计算组织氧的消耗和血流，以及携带有关各种组织区域的生物力学特性的固有信息。在这些最初的结果的鼓励下，我们建议对PAR-07-214响应于PAR-07-214，以开发一种将高时间分辨率TOBI与任何商业乳房X线摄影或质膜合成设备整合在一起的能力，并能够通过为光学患者界面采用X射线半透明材料来获取同时X射线和时间分解的光学图像。这种系统的开发将允许进行I期临床试验的性能，在该试验中，可以评估光学静态，动态和代谢标记的诊断性能，以收集必要的统计信息以计划II期有效性试验。该提案利用长期的关系，将Boas博士（领先的光学技术和算法开发公司）组合在一起，Techen Inc.，Techen Inc.是一家定制工程公司，具有丰富的经验，建立了交钥匙的光学成像系统，以及Kopans博士的临床组，Kopans博士是数字乳腺癌发展的开发的先驱。 TechEn, in close collaboration with Dr. Boas' group will construct a commercial grade prototype of the dynamic optical imaging system and in collaboration with Dr. Kopans the system will be clinically tested on women presenting for breast cancer screening as well as for follow-up diagnosis with the goal of fine tuning clinical operating procedure and refining the instrumentation, as well as gathering initial data on the diagnostic value of optical tissue parameters, and their ability to enhance the sensitivity and specificity X射线间歇合成。公共卫生相关性：光学癌标志物的发展可能会提高X雷乳房X线摄影的敏感性，从而减少遗漏的早期癌症；同时，特异性的提高可能会减少不必要的活检的数量，从而降低患者焦虑和医疗保健成本。 公共卫生相关性： 光学癌标记物的发展可能会提高X射线乳腺X线摄影的敏感性，从而减少遗漏的早期癌症。同时，特异性的提高可能会减少不必要的活检的数量，从而降低患者焦虑和医疗保健成本。