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

前列腺 MRI 虚拟病理学：多中心多供应商应用和验证

• 批准号: 10650383
• 负责人: Aritrick Chatterjee
• 金额: $ 102.55万
• 依托单位: QMIS, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10650383
• 关键词: Agreement; Biopsy; Blood Tests; Cessation of life; Client; Clinical; Clinical Trials; Computer software; Confidentiality of Patient Information; Data; Development; Diagnosis; Dimensions; Early Diagnosis; Ensure; Epithelium; Evaluation; Exclusion; Funding; Gleason Grade for Prostate Cancer; Goals; Health Personnel; Histology; Hybrids; Image; Information Systems; Literature; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Manufacturer; Marketing; Measures; Methods; Modeling; Morphologic artifacts; Multi-Institutional Clinical Trial; Normal tissue morphology; Outcome; Pathologist; Pathology; Patients; Phase; Physicians; Prostate; Prostate-Specific Antigen; Publishing; Records; Reporting; Reproducibility; Scanning; Screening for Prostate Cancer; Screening procedure; Sensitivity and Specificity; Series; Site; Small Business Technology Transfer Research; Software Tools; System; Testing; Thinness; Tissues; Training; United States National Institutes of Health; United States Preventative Services Task Force; Validation; Vendor; Work; cancer diagnosis; cancer type; clinical application; clinical diagnosis; clinical efficacy; clinical research site; clinically significant; cloud based; commercialization; diagnostic accuracy; effectiveness evaluation; experience; health care availability; high risk men; improved; improved outcome; manufacture; men; novel; overtreatment; product development; prostate cancer risk; radiologist; research and development; research clinical testing; scale up; screening; side effect; software infrastructure; tool; ultrasound; user-friendly; virtual

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.

项目总结 美国预防工作组发现目前基于超声波的筛查方法不可靠，导致 不必要的活检和未能检测到具有临床意义的前列腺癌(PCa) 前列腺特异性抗原(PSA)。仅在美国就有数百万男性目前患前列腺癌的风险增加，但 都不是有效的筛查选择。虽然MRI作为二线筛查和高危筛查 男性逐渐增多，MRI的敏感性和特异性目前还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。 定量核磁共振解决方案公司(QMIS)，LLC开发了一种新的MR前列腺虚拟病理(MVP2) 用于前列腺癌筛查和诊断的定量MRI分析和解释软件工具。MVP2使用 混合多维磁共振成像(HM-MRI)数据的隔室分析以量化三个体积分数 组织间隙：管腔、间质和上皮。这提供了新的基于HM-MRI的PCA高水平标志物 上皮性、低间质和管腔部分提示为前列腺癌。在我们之前资助的NCI第一阶段STTR中，我们 完成所有技术和物流研发目标。具体来说，我们成功地开发和优化了 最大限度地使MVP2和黄金标准定量之间的一致性达到最大的基础隔室模型 组织学以及由专家病理学家对组织成分的评估。我们证明了 MVP2与基于前列腺影像报告和数据系统(PIRAD)的临床评估进行比较。在……里面 此外，我们开发和测试了一个用户友好的界面，以有效地执行我们的软件。我们的 软件解决方案符合FDA的要求。第一阶段的结果是证明了MVP2的可行性 PCa临床筛查和诊断软件。 这一第二阶段提案的目标包括：a)通过开发和开发 测试基于云的MVP2，可与领先的MRI扫描仪品牌配合使用，b)展示 MVP2用于通过多中心临床试验指导活检，以及c)证明MVP2与来自 三大厂商。第二阶段的结果将为自控镇痛的临床疗效提供强有力的证据 MVP2‘筛查。这将使QMIS在广阔的PCA筛查市场上具有很强的竞争力。MVP2将 帮助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而提高了存活率，即使在医生培训不够理想的情况下也是如此。