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

基本信息

批准号：
9816241
负责人：
SHUDONG JIANG
金额：
$ 56.4万
依托单位：
DARTMOUTH COLLEGE
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-07-01 至 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9816241
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 Data Quality 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 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

项目摘要

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.

项目概要虽然动态对比增强磁共振成像 (DCE MRI) 被认为是最敏感的乳腺癌检测的检查，有相当大的假阳性率和注射钆（Gd）造影剂似乎存在安全风险。因此，基于诊断乳腺癌的替代方法内生对比越来越引起人们的兴趣。该提案的总体目标是开发和评估并发近红外光谱 (NIRS) 和 MRI 成像平台，探讨是否将两者结合起来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效果诊断性能。该提案的科学前提是以初步临床数据为基础的研究表明，MR 引导 (MRg) NIRS 为乳腺 MRI 增添了急需的诊断特异性。我们也会探索令人兴奋的假设，即 MRg NIRS 可替代 DCE MRI，并且类似或相同可以通过将 MRg NIRS 添加到非对比 MRI 序列来获得诊断性能，从而无需注射造影剂。在初步研究中，敏感性、特异性、准确性和 AUC 与 T2 引导的 NIRS 结合使用时，非对比 MRI 的准确率分别为 94%、100%、96% 和 0.95，而单独使用 DCE-MRI 时，这些值分别为 94%、63%、88% 和 0.81。这个性能还可以提高甚至进一步通过图像直接正则化（DRI）方法和多目标先验，我们建议在目标 2 中进行调查。同样重要的是，我们发现 MRg NIRS 的诊断性能并未降低当使用 CW 信号形成 NIRS 图像时，只要获得对象特定的散射估计值（在目标 1 中）。事实上，我们当前的 MRg NIRS 系统的实际效用因其对 FD 的依赖而受到损害数据，以及将光传输到数据采集硬件或从数据采集硬件传输到乳房的长、大芯光纤束扫描仪内部。消除这些笨重的承重光缆还简化了乳房光学成像接口，并为创新、临床友好的设计开发新选项打开了大门目标 1 中提出。我们将在模型和志愿者中迭代验证该平台（目标 3）并评估在一项临床研究中，新的 MRg NIRS + MRI 技术在结合或不结合造影剂注射时 60名乳房异常患者。该项目利用了我们开发的广泛基础设施诊断放射学和生物医学工程研究人员进行的平移乳腺成像二十多年来合作开发和评估先进技术。