MRI Virtual Pathology of the Prostate: Multi-center multi-vendor application and validation

项目摘要 美国预防性工作组发现，目前基于超声波的筛查方法不可靠， 不必要的活检和未能检测到临床显著的前列腺癌（PCa）的患者， 前列腺特异性抗原（PSA）。仅在美国就有数百万男性目前面临PCa的高风险，但在美国， 没有有效的替代筛查方法。虽然MRI作为二线筛查和高危筛查 由于男性的发病率逐渐增加，MRI的灵敏度和特异性目前不足以大规模临床使用。 因此，迫切需要新的和更准确的非侵入性方法来指导活检， 确认PCa 定量MRI解决方案（QMIS），LLC开发了前列腺MR虚拟病理学（MVP 2）-一种新的 用于PCa筛查和诊断的定量MRI分析和解释软件工具。MVP 2使用 混合多维MRI（HM-MRI）数据的房室分析，以量化三种MRI的体积分数 组织间隙：管腔、基质和上皮。这提供了新的基于HM-MRI的PCa标记物， 上皮和低基质和管腔部分指示PCa。在我们之前资助的NCI第一阶段STTR中，我们 完成了所有技术和后勤研发目标。具体来说，我们成功地开发和优化了 基础房室模型，以最大限度地提高MVP 2和金标准定量之间的一致性 组织学以及专家病理学家对组织组成的评价。我们证明了 MVP 2与基于前列腺成像报告和数据系统（PIRAD）的临床评价进行比较。在 此外，我们开发并测试了一个用户友好的界面，以有效地执行我们的软件。我们 软件解决方案符合FDA要求。第一阶段的成果是证明了MVP 2的可行性 PCa临床筛查和诊断软件。 第二阶段提案的目标包括：a）通过开发和 测试与领先的MRI扫描仪品牌配合使用的基于云的MVP 2，B）证明 MVP 2通过多中心临床试验用于引导活检，以及c）证明MVP 2与来自 三大制造商。II期的结果将为PCa的临床疗效提供有力的证据 用MVP 2筛选。这将使QMIS在PCa筛查的广阔市场中具有很强的竞争力。MVP 2将 有助于改善数百万有前列腺癌风险的男性的预后，减少误诊和过度治疗， 由于早期发现和有效筛查，即使医生培训欠佳，也能提高生存率。

PROJECT SUMMARY The U.S. Preventative Task Force found current ultrasound-based screening methods unreliable, causing unnecessary biopsies and failing to detect clinically significant Prostate Cancer (PCa) in patients with an elevated prostate-specific antigen (PSA). Millions of men in the U.S. alone are currently at elevated risk for PCa, but there are no effective alternatives for screening. Although MRI as a second-line screening and screening of high-risk men is gradually increasing, MRI sensitivity and specificity are currently inadequate for large-scale clinical use. Thus, there is a critical need for new and more accurate non-invasive approaches to guide the biopsies for confirming PCa. Quantitative MRI Solutions (QMIS), LLC has developed MR Virtual Pathology of the Prostate (MVP2) – a new quantitative MRI analysis and interpretation software tool for PCa screening and diagnosis. MVP2 uses compartmental analysis of hybrid-multidimensional MRI (HM-MRI) data to quantify volume fractions of three tissue spaces: lumen, stroma, and epithelium. This provides novel HM-MRI-based markers of PCa as high epithelial and low stromal and luminal fractions indicate PCa. In our previously funded NCI Phase I STTR, we accomplished all technical and logistical R&D goals. Specifically, we successfully developed and optimized the underlying compartment model to maximize agreement between MVP2 and the gold standard quantitative histology as well as evaluation of tissue composition by expert pathologists. We demonstrated the accuracy of MVP2 compared with clinical evaluation based on Prostate Imaging Reporting and Data System (PIRAD). In addition, we developed and tested a user-friendly interface for the efficient execution of our software. Our software solution is consistent with FDA requirements. The outcome of Phase I is the proven feasibility of MVP2 software for clinical screening and diagnosis of PCa. The goals of this Phase II proposal include a) ensure successful commercialization at scale by developing and testing a cloud-based MVP2 that works with leading MRI scanner brands, b) demonstrate the clinical efficacy of MVP2 for guiding biopsy via multicenter clinical trial, and c) demonstrate that MVP2 works with scanners from the 3 major manufacturers. The results from Phase II will provide strong evidence for the clinical efficacy of PCa screening with MVP2’. This will make QMIS highly competitive in the vast market for PCa screening. MVP2 will help to improve outcomes for millions of men at risk of PCa, leading to reduced misdiagnosis and overtreatment, increased survival due to early detection, and effective screening even with sub-optimal physician training.