Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to enhance MRI diagnostic capabilities in Prostate Cancer

项目总结/摘要 在美国，前列腺癌影响近七分之一的男性，但早期侵袭性癌症的诊断 以许多不必要的活检为代价，活检取样错误导致诊断延迟， 或惰性疾病的诊断。为了诊断临床上显著的前列腺癌， 迫切需要找到一种可以统一实施但还提供临床效用的成像模态。核磁共振- 引导的前列腺活检已经迅速成为进行前列腺活检的常见模式;然而， 重点放在图像采集的质量和准确性上。 我们的提案支持学术界和工业界的合作，以开发和成像生物标志物， 通过使用限制光谱成像（RSI）-MRI，彻底改变了前列腺癌的诊断和监测方式。 我们寻求改善前列腺MRI的操作特点，一种新的，非侵入性的方法， 持续时间，靶向磁RSI-MRI序列然后经过FDA批准的II类后处理软件 (OnQ前列腺）来将值归属于前列腺的可疑区域。RSI-MRI采用多个b值 在每个b值处使用多个扩散梯度方向进行采集，以采集原始数据; 处理以将信号与通常在癌细胞中发现的各向同性的受限水隔室分离。一 得到对应于肿瘤位置的所得“限制信号图”并对其进行量化， 肿瘤分级的体内生物标志物，并增强了肿瘤的显着性，供读者检测。在目标1中，我们寻求验证 我们以前的研究结果有关的操作特点的RSM值及其关联的临床 严重的前列腺癌（2级或更高）。我们将使用非随机、单组临床试验， 研究有和没有RSM值的PI-RADS评分。在目标2中，我们看到要校准RSM图 制造商（Siemens、GE和菲利普斯MRI扫描仪）之间的值。我们将使用双扫描方法， 将邀请一组具有一系列PI-RADS值的男性样本，在他们完成以下操作后进行研究参考扫描： 在特定MRI供应商所在的三个地点之一接受标准护理扫描。两 扫描将进行比较，并用于使用几种校准和归一化来校准RSM值 有针对性的活检结果的技术。在一些接受乳房切除术的男性中，我们将进一步 使用术前MRI对前列腺进行建模，然后进行整体切片，扫描和对齐 通过RSI-MRI获得正常和癌症区域的准确读数。在目标3中，我们将RSM与当前 可用的FDA批准的生物标志物和临床风险来确定临床实用性。 在拟议的项目中，我们试图提高前列腺MRI的特异性使用RSI。具体交付成果将 包括用特定RSM输出值修改标准放射报告系统（PI-RADS）的能力。 我们寻求验证供应商之间的受限信号图，并提供临床评估工具 证明了临床实用性的测量。

Project Summary/Abstract Prostate cancer affects nearly 1 in 7 men in the United States yet the diagnosis of early aggressive cancer remains elusive at the expense of many unnecessary biopsies, delay in diagnosis from biopsy sampling error, or the diagnosis of indolent disease. In order make a diagnose clinically significant prostate cancer, there is an urgent need find an imaging modality that can be implemented uniformly, yet also provide clinical utility. MRI- guided prostate biopsy has rapidly become a common modality to perform prostate biopsy; however, limited emphasis has been placed on the quality and accuracy of the image acquisition. Our proposal supports an academic-industry partnership to develop and imaging biomarker that could revolutionize how prostate cancer is diagnosed and monitored by using restriction spectrum imaging (RSI)-MRI. We seek to improve the operating characteristics of prostate MRI with a novel, non-invasive method of a short- duration, targeted magnetic RSI-MRI sequences then undergo FDA-cleared, class II post-processing software (OnQ Prostate) to attribute values to suspicious areas of the prostate. RSI-MRI employs multiple b-value acquisitions with multiple diffusion gradient directions at each b-value to acquire raw data; images are post- processed to isolate the signal from isotropic, restricted water compartments typically found in cancer cells. A resultant “restricted signal map” corresponding to tumor location is derived and quantified functioning as an in vivo biomarker of tumor grade and enhances tumor conspicuity for reader detection. In Aim 1, weseek to validate our previous findings regarding the operating characteristics of the RSM values and its association with clinically significant prostate cancer (grade group 2 or higher). We will use a non-randomized, single arm clinical trial to investigate both PI-RADS scores with and without the RSM values. In Aim 2, we see to calibrate the RSM map values across manufacturers(Siemens, GE, and Phillips MRI scanners). We will use a two-scan approach which will invite a sample of men with a range of PI-RADS values to undergo a research reference scan after they have undergone their standard of care scan within one of three locations housing a specific MRI vendor. The two scans will be compared and used to calibrate the RSM values using several calibration and normalization techniques with targeted biopsy results. In some men that do undergo prostatectomy, we will further make a mold of the prostate using the preoperative MRI then perform whole-mount sectioning, scanning, and alignment with RSI-MRI to obtain accurate reads of normal and cancer areas. In Aim 3, we will compare RSM to currently available FDA-approved biomarkers and clinical risk to determine clinical utility. In the proposed project, we seek to improve specificity of prostate MRI using RSI. Specific deliverables will include the ability to amend the standard radiological reporting system (PI-RADS) withspecific RSM output vales. We seek to validate the restricted signal maps between vendors and provide clinical assessment tools demonstrating a measurement of clinical utility.