Concurrent Optical Spectroscopy and Breast MRI to Improve Diagnosis without Contrast Injection

同步光学光谱和乳腺 MRI 无需注射造影剂即可改善诊断

• 批准号: 10402775
• 负责人: SHUDONG JIANG
• 金额: $ 54.15万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10402775
• 关键词: Adhesives; Area Under Curve; Axilla; Biomedical Engineering; Brain; Breast; Breast Cancer Detection; Breast Magnetic Resonance Imaging; Clinical; Clinical Management; Clinical Research; Clinical Trials; Collaborations; Contrast Media; Curiosities; Data; Deposition; Development; Diagnosis; Diagnostic; Diagnostic Specificity; Diagnostic radiologic examination; Diffusion Magnetic Resonance Imaging; Dose; Fiber; Frequencies; Funding; Gadolinium; Geometry; Goals; Hemoglobin; Human; Image; Imaging technology; Impairment; Infrastructure; Injections; Ionizing radiation; Ions; Kidney; Letters; Light; Lipids; Magnetic Resonance Imaging; Modality; Near-Infrared Spectroscopy; Nephrogenic Systemic Fibrosis; Optics; Outcome; Oxygen; Paper; Patients; Performance; Perfusion; Procedures; Publishing; ROC Curve; Renal function; Research Personnel; Risk; Safety; Scanning; Sensitivity and Specificity; Signal Transduction; Specificity; Spectrum Analysis; System; Techniques; Technology; Time; Tissues; Translating; United States Food and Drug Administration; Update; Water; Weight-Bearing state; Woman; Work; base; bone; breast cancer diagnosis; breast exam; breast imaging; clinical practice; contrast enhanced; cost; data acquisition; data quality; design; diagnostic accuracy; high risk; human data; imaging approach; imaging modality; imaging platform; improved; innovation; interest; malignant breast neoplasm; medication safety; multimodality; optical imaging; radiologist; research clinical testing; screening; spectroscopic imaging; volunteer

PROJECT SUMMARY While dynamic contrast-enhanced magnetic resonance imaging (DCE MRI) is recognized as the most sensitive examination for breast cancer detection, it has a substantial false positive rate and injection of gadolinium (Gd) contrast agents appears to have safety risks. Thus, alternatives to diagnosing breast cancer based on endogenous contrast are of growing interest. The overall goal of this proposal is to develop and evaluate a concurrent near-infrared spectroscopy (NIRS) and MRI imaging platform to explore whether the combined modality, which does not require contrast injection or involve ionizing radiation, can achieve acceptable diagnostic performance. The scientific premise of this proposal is underpinned by data from preliminary clinical studies that show MR-guided (MRg) NIRS adds much needed diagnostic specificity to breast MRI. We will also explore the exciting hypothesis that MRg NIRS serves as a surrogate for DCE MRI, and similar or the same diagnostic performance can be obtained by adding MRg NIRS to non-contrast MRI sequences, thereby eliminating the need for contrast injection. In preliminary studies, sensitivity, specificity, accuracy, and AUC of non-contrast MRI when combined with T2-guided NIRS were 94%, 100%, 96%, and 0.95, respectively, whereas these values were 94%, 63%, 88%, and 0.81 for DCE-MRI alone. This performance can be improved even further through direct regularization from images (DRI) methods and multi objective priors we propose to investigate in Aim 2. Equally important, we found the diagnostic performance of MRg NIRS is not degraded when CW signals are used to form NIRS images as long as subject specific scattering estimates are obtained (in Aim 1). Indeed, the practical utility of our current MRg NIRS system is undermined by its reliance on FD data, and the long, large-core fiber bundles that transmit light to/from data acquisition hardware to the breast inside the scanner. Elimination of these bulky weight-bearing fiber cables also simplifies the breast optical imaging interface, and opens the door to development of new options for the innovative, clinical-friendly design proposed in Aim 1. We will validate this platform iteratively in phantoms and volunteers (in Aim 3) and evaluate the new MRg NIRS + MRI technology when combined with and without contrast injection in a clinical study of 60 patients with breast abnormalities. The project leverages an extensive infrastructure we have developed for translational breast imaging where investigators from diagnostic radiology and biomedical engineering have collaborated to develop and evaluate advanced technology for more than two decades.

项目摘要 而动态对比增强磁共振成像（DCE MRI）被认为是最敏感的 检查乳腺癌的检测，它有很大的假阳性率和注射钆（Gd） 造影剂似乎具有安全风险。因此，基于乳腺癌的诊断的替代方案 内源性对比度越来越受到关注。本提案的总体目标是制定和评估一个 同时近红外光谱（NIRS）和MRI成像平台，以探讨是否结合 不需要造影剂注射或涉及电离辐射的方式，可以达到可接受的 诊断性能。这一建议的科学前提得到了初步临床试验数据的支持。 研究表明，MR引导（MRg）NIRS为乳腺MRI增加了急需的诊断特异性。我们还将 探索令人兴奋的假设，即MRg NIRS可作为DCE MRI的替代品， 可通过将MRg NIRS添加到非造影MRI序列中来获得诊断性能，从而 消除了对造影剂注射的需要。在初步研究中， 结合T2引导NIRS的非增强MRI分别为94%、100%、96%和0.95， 而对于单独的DCE-MRI，这些值分别为94%、63%、88%和0.81。这种性能可以得到改善 甚至进一步通过图像直接正则化（DRI）方法和多目标先验，我们提出， 目标2调查。同样重要的是，我们发现MRg NIRS的诊断性能并未降低 当CW信号用于形成NIRS图像时，只要获得对象特定散射估计 (in目标1）。事实上，我们目前的MRg近红外光谱系统的实际效用是削弱了它对FD的依赖 数据，以及将光传输到数据采集硬件/从数据采集硬件传输到乳房的长、大芯光纤束 在扫描仪里面。消除这些笨重的承重光纤电缆也简化了乳房光学 成像接口，并打开了大门，开发新的选择创新，临床友好的设计 在目标1中提出。我们将在体模和志愿者中反复验证这个平台（在目标3中），并评估 新的MRg NIRS + MRI技术在联合和不联合造影剂注射的临床研究中 60例乳腺异常患者。该项目利用了我们开发的广泛的基础设施， 平移乳腺成像，来自诊断放射学和生物医学工程的研究人员 合作开发和评估先进技术超过二十年。