Breast Cancer Risk Stratification with Resonant Electrical Impedance Spectroscopy

使用共振电阻抗谱进行乳腺癌风险分层

• 批准号: 7804524
• 负责人: DAVID GUR
• 金额: $ 41.03万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7804524
• 关键词: Address; Age; Algorithms; Back; Biological Neural Networks; Biopsy; Breast; Breast Cancer Detection; Breast Cancer Early Detection; Categories; Classification; Clinical; Data; Data Set; Devices; Diagnostic; Diagnostic Imaging; Diagnostic Procedure; Digital Mammography; Disease; Drops; Effectiveness; Equipment; Evaluation; Exposure to; Foundations; Frequencies; General Population; Genetic Programming; Gold; High Risk Woman; Human; Image; Imaging technology; Incidence; Injection of therapeutic agent; Machine Learning; Magnetic Resonance Imaging; Malignant Neoplasms; Mammary Gland Parenchyma; Mammography; Measurement; Measures; Medical; Methodology; Modality; Modification; Noise; Office Visits; Palpable; Performance; Persons; Phase; Plague; Population; Premenopause; Procedures; Property; Prospective Studies; Public Health; Radiation; Recommendation; Recruitment Activity; Risk; Role; Scanning; Screening procedure; Sensitivity and Specificity; Signal Transduction; Site; Skin; Specificity; Spectrum Analysis; Stratification; Subgroup; Surface; System; Techniques; Technology; Testing; Tissues; Training; Western World; Woman; Women' s Group; age group; base; breast density; cancer risk; cost; design; electric impedance; follow-up; high risk; imaging modality; improved; in vivo; malignant breast neoplasm; novel strategies; older women; patient population; prototype; sensor; tool

DESCRIPTION (provided by applicant): Although risk for developing breast cancer at an earlier age is low in a substantial fraction of person-years lost it is attributed to women under the age of 40 who die from this disease. Unfortunately, screening mammography, the "gold standard" and accepted practice over the age of 40 for breast cancer detection, performs poorly in younger women and combined with radiation risk and expected low yield resulted in the recommendation that annual screening in the general population is not recommended below this age. Alternative imaging modalities exist (e.g. MRI, US), however, these techniques are not being used for this purpose for a variety of reasons. It would greatly facilitate breast cancer detection in younger women if an inexpensive, easy to use, widely available technology was available to pre-screen women and determine who would most likely benefit from more comprehensive imaging based studies. Currently, the only generally used screening tool in young women is Clinical Breast Exam (CBE). However, CBE has low sensitivity, high false- positive rate and is examiner dependent. Electrical Impedance Spectroscopy (EIS) is a promising technology for fulfilling a pre-screening risk identification role as it relies on relatively inexpensive equipment that could be widely disseminated to practitioners' offices and it has demonstrated some effectiveness in detecting breast cancer regardless of age or breast density. Unfortunately, EIS technologies have demonstrated a relatively low sensitivity (~ 25 - 35%) when a high specificity (>90%) is required. Recently a new approach to EIS measurements has been developed and used quite successfully in non-medical applications. This new approach measures shifts in impedance near the resonant frequency when tissue is made a part of an RLC electric circuit. We refer to this new approach as Resonant Electrical Impedance Spectroscopy (REIS). The sensitivity of EIS near the resonant frequency is extremely high and we believe that using this approach (REIS) a much greater diagnostic performance can be achieved than was previously obtainable with EIS. In the R21 phase of this study we will build a prototype REIS device for rapidly evaluating (less than 10 minues) the breast and demonstrate feasibility for pre-screening women with the REIS device to determine who would benefit from a diagnostic imaging workup. This is not a breast cancer detection device but rather a risk stratification approach. Namely, the ultimate objective is to develop and test an approach that would segment the younger women population (< 40 years old) into two groups. One (REIS negative) that is expected to have normal risk of having breast cancer and the other (REIS positive) which identifies a group of women in which the risk of having breast cancer is substantially higher than in older women (40 - 49 years old) who are currently routinely screened. In the R33 phase a much larger patient population will be recruited and will be used to optimize the classification algorithm. Comparisons will be made with existing EIS technology. In this application we are proposing building and evaluating a device for identifying pre-menopausal women who are at increased risk for breast cancer and would thus benefit from an imaging based evaluation of the breast. This would be achieved using a low cost, safe technology that could be used during routine office visits of young women who are not screened with mammography. If successful, this proposal will have a large public health impact via increased early detection of breast cancer.

描述（由申请人提供）：虽然在很大一部分人-年损失中，早期患乳腺癌的风险较低，但这归因于40岁以下死于这种疾病的妇女。不幸的是，筛查性乳房X光检查，40岁以上乳腺癌检测的“黄金标准”和公认的做法，在年轻妇女中表现不佳，加上辐射风险和预期的低产量，导致建议不建议在一般人群中进行年度筛查低于这个年龄。存在替代成像模式（例如MRI、US），但是，由于各种原因，这些技术未用于此目的。如果有一种廉价、易于使用、广泛可用的技术可用于对妇女进行预筛查，并确定谁最有可能从更全面的基于成像的研究中受益，这将大大促进年轻妇女的乳腺癌检测。目前，年轻女性唯一普遍使用的筛查工具是临床乳房检查（CBE）。但CBE敏感性低，假阳性率高，且依赖于检查者.电阻抗谱（EIS）是一种很有前途的技术，用于履行预筛选风险识别的作用，因为它依赖于相对便宜的设备，可以广泛传播到从业者的办公室，它已被证明在检测乳腺癌，无论年龄或乳房密度的一些有效性。不幸的是，当需要高特异性（>90%）时，EIS技术的灵敏度相对较低（~ 25 - 35%）。最近开发了一种新的EIS测量方法，并在非医疗应用中非常成功地使用。这种新方法测量当组织成为RLC电路的一部分时谐振频率附近的阻抗变化。我们将这种新方法称为谐振电阻抗谱（REIS）。共振频率附近的灵敏度EIS是非常高的，我们相信，使用这种方法（REIS）可以实现更大的诊断性能比以前获得的EIS。在本研究的R21阶段，我们将建立一个原型REIS设备，用于快速评估（不到10分钟）乳房，并证明使用REIS设备对女性进行预筛选的可行性，以确定谁将从诊断成像检查中受益。这不是一种乳腺癌检测设备，而是一种风险分层方法。也就是说，最终目标是制定和测试一种方法，将年轻妇女人口（< 40岁）分为两组。一种（REIS阴性）预期具有患乳腺癌的正常风险，另一种（REIS阳性）确定了一组女性患乳腺癌的风险大大高于目前常规筛查的老年女性（40 - 49岁）。在R33阶段，将招募更大的患者人群，并将用于优化分类算法。将与现有的EIS技术进行比较。在本申请中，我们提出构建和评估一种用于识别绝经前女性的设备，这些绝经前女性患乳腺癌的风险增加，因此将受益于基于成像的乳房评估。这将通过一种低成本、安全的技术来实现，这种技术可以在没有接受乳房X光检查的年轻妇女的例行办公室访问中使用。如果成功的话，这一提议将通过增加乳腺癌的早期发现而对公共卫生产生巨大的影响。