Moffitt Imaging Biomarker VAlidation Center

 描述(申请人提供)：我们建议建立莫菲特成像生物标记物验证中心(MIBVAC)，通过利用我们强大的专家团队、资源、计划的成像生物标记物验证研究以及分析和网络协作结构，专注于癌症早期检测和准确风险评估的成像生物标记物验证。在以前的研究中，我们已经证明了来自乳房图像的各种测量可以量化乳腺癌的风险。大型协作性国家肺部筛查试验(NLST)也显示，与传统放射检查相比，低剂量CT筛查的患者存活率显著提高。此外，我们最近已经证明，CT图像分析(放射组学)可以改善该数据集中的分类。然而，由于难以获得准确和可重复性的测量结果，以及当前成像的高假阳性率，肿瘤成像生物标记物并未被常规地纳入临床风险评估。如果这些成像生物标记物能够在个体水平上得到准确的定制，它们对癌症早期检测和干预的影响将显著提高。MIBVAC计划通过严格评估和验证这些快速转化为临床和实际应用的成像生物标记物来实现这一具有挑战性但相当可实现的目标。我们有四个具体目标：(目标1)利用我们现有的和新的乳房图像病例对照数据集建立EDRN的乳房成像资源，并基于新建立的数字乳房断层扫描(TS)图像的病例对照数据集评估和验证乳房成像生物标记物，(目标2)首先基于NLST低剂量CT(LDCT)队列评估和验证用于癌症早期检测的肺部成像生物标记物，然后利用新建立的高分辨率LDCT病例对照队列进行验证研究，(目标3)利用EDRN合作伙伴和其他恶性肿瘤的成像生物标记物进行验证研究，和(目标4)提炼和验证用于乳腺癌、肺癌和其他癌症早期检测的分析成像生物标记物，并构建用于EDRN合作和共享的MIBVAC成像数据和标本资源。

 DESCRIPTION (provided by applicant): We propose to establish the Moffitt Imaging Biomarker Validation Center (MIBVAC) focused on imaging biomarker validations for early cancer detection and accurate risk assessments by leveraging our team of strong experts, resources, planned imaging biomarker validation studies, and analysis and network collaboration structures. In previous studies we have demonstrated that various measurements from breast images quantify breast cancer risk. The large cooperative National Lung Screening Trial (NLST) also showed a significant survival improvement for individuals screened by low dose CT compared to those screened with conventional radiography. Additionally, we have recently shown that CT image analysis (radiomics) can improve classification in this data set. However, due to difficulties in obtaining accurate and reproducible measurements and high false-positive rates of current imaging, cancer imaging biomarkers have not been routinely incorporated into clinical risk assessment. If these imaging biomarkers can be accurately tailored at the individual level, their impact will be significantly improved for early cancer detection and intervention. MIBVAC plans to achieve this challenging yet quite achievable goal by rigorously evaluating and validating these imaging biomarkers for rapid translation into clinical and practical applications. We have four specific aims: (Aim 1) Establish breast imaging resources for EDRN both with our existing and new case-control datasets of breast images and to evaluate and validate breast imaging biomarkers based on newly-established case-control dataset of digital breast tomosynthesis (TS) images, (Aim 2) Evaluate and validate lung imaging biomarkers for early detection of cancer first based on NLST low-dose CT (LDCT) cohorts and then expanding with a newly-established case-control cohort of higher resolution LDCT, (Aim 3) Conduct validation studies with imaging biomarkers for EDRN partners and others for other malignancies, and (Aim 4) Refine and validate imaging biomarkers analytically for early detection of breast, lung, and other cancers and to construct MIBVAC imaging data and specimen resources for EDRN collaborations and sharing.