Diffusion Histology Imaging: A Clinical Tool to Non-Invasively Diagnose and Manage Prostate Cancer

弥散组织学成像：非侵入性诊断和治疗前列腺癌的临床工具

• 批准号: 10364097
• 负责人: Joseph Edward Ippolito
• 金额: $ 54.32万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-01 至 2026-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10364097
• 关键词: Address; Benign; Benign Prostatic Hypertrophy; Biological Markers; Biopsy; Blood; Blood Tests; Cancer Patient; Clinical; Data; Diagnosis; Diagnostic; Diffusion; Disease Progression; Extraprostatic; General Population; Gleason Grade for Prostate Cancer; Goals; Gold; Histology; Hospitalization; Image; Image Analysis; Indolent; Interdisciplinary Study; Liquid substance; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Methods; Modeling; Monitor; Nomograms; Operative Surgical Procedures; PSA screening; Pathologic; Pathology; Patient Selection; Patients; Periodicity; Procedures; Prostate; Prostate-Specific Antigen; Prostatectomy; Prostatic Diseases; Protocols documentation; Radiation; Radical Prostatectomy; Reference Standards; Risk; Seminal Vesicles; Sensitivity and Specificity; Sepsis; Testing; Tissues; Training; United States; Update; Urine; Visualization; accurate diagnosis; artificial intelligence algorithm; base; cancer diagnosis; clinical care; clinical imaging; clinical risk; clinical translation; clinically significant; cohort; disorder risk; high risk; improved; men; non-invasive monitor; noninvasive diagnosis; novel; overtreatment; patient screening; patient subsets; performance tests; prospective; prostate biopsy; prostate cancer risk; prostatitis; recruit; research clinical testing; risk prediction; risk stratification; screening; spectrograph; standard of care; tool; tumor

PROJECT SUMMARY There are clear limitations to the current approach to prostate cancer (PCa) diagnosis. Approximately half of the men who undergo a transrectal prostate biopsy—an extremely uncomfortable, invasive procedure with significant risk including sepsis—are not found to have PCa. For those who have PCa, many have indolent cancers that are best managed with active surveillance (AS), which requires annual repeat biopsies due to a lack of accurate noninvasive tools. Biomarkers and prostate magnetic resonance imaging (MRI) have been increasingly used to attempt to address this problem. However, the currently available tools are not accurate enough alone or in combination to forgo biopsy. We have developed a new MRI sequence (diffusion basis spectrum imaging) and a method of analyzing these imaging metrics—diffusion histology imaging (DHI)—that may overcome the limitations of conventional MRI interpretation. Preliminary data demonstrates high accuracy of DHI to predict prostate biopsy results (presence of cancer and grade of cancer when present). We aim to apply DHI to patients in two distinct clinical settings: Aim 1, initial biopsy for PSA screening, and Aim 2, repeat biopsy for known indolent PCa managed with AS. We also plan for Aim 3 to update our DHI model based on the data obtained in these aims, then recruit and test the updated DHI model in an independent group of patients undergoing PSA screening. We hypothesize that DHI will allow for accurate and non-invasive diagnosis of PCa, and thus reduce unnecessary biopsies. In our proposed studies, the men will have had biomarker testing, then receive a clinical prostate MRI (conventional sequences) with the DBSI imaging protocol added onto it prior to biopsy. The DBSI imaging will be analyzed post-acquisition by our DHI model. Note that the DBSI protocol will add just a few minutes to the total duration of the clinical MRI and will not significantly impact the patient or the clinical imaging workflow. In parallel to conventional MRI interpretation and biopsy per clinical care, our team will perform DHI analysis on the MRI images. By comparing DHI to biomarkers and conventional MRI against the histopathologic gold standard (biopsy) in a prospective manner, we will determine if DHI can be used to noninvasively diagnose and monitor PCa; therefore, supporting the clinical translation of DHI to be used as an alternative to invasive biopsies.

项目概要 目前的前列腺癌（PCa）诊断方法存在明显的局限性。大约一半 接受经直肠前列腺活检的男性——这是一种极其不舒服的侵入性手术 未发现患有 PCa 的重大风险，包括败血症。对于那些患有 PCa 的人来说，许多人都有惰性 最好通过主动监测（AS）来管理的癌症，由于主动监测需要每年重复活检 缺乏准确的非侵入性工具。生物标志物和前列腺磁共振成像 (MRI) 越来越多地尝试解决这个问题。然而，目前可用的工具并不准确 单独或组合足以放弃活检。 我们开发了一种新的 MRI 序列（扩散基础频谱成像）以及分析这些序列的方法 成像指标——弥散组织学成像 (DHI)——可以克服传统 MRI 的局限性 解释。初步数据表明 DHI 预测前列腺活检结果的准确性很高 （癌症的存在和癌症的级别（如果存在）。我们的目标是将 DHI 应用于两个不同的临床患者 设置：目标 1，用于 PSA 筛查的初始活检，目标 2，对已知的惰性 PCa 进行重复活检 与AS。我们还计划在目标 3 中根据这些目标中获得的数据来更新我们的 DHI 模型，然后 在接受 PSA 筛查的独立患者组中招募并测试更新的 DHI 模型。我们 假设 DHI 将能够对 PCa 进行准确且无创的诊断，从而减少不必要的 活检。 在我们提出的研究中，男性将进行生物标志物测试，然后接受临床前列腺 MRI （传统序列），并在活检之前添加 DBSI 成像协议。 DBSI 成像将 收购后通过我们的 DHI 模型进行分析。请注意，DBSI 协议只会向 临床 MRI 的总持续时间，不会对患者或临床成像工作流程产生重大影响。在 与每个临床护理的传统 MRI 解释和活检并行，我们的团队将进行 DHI 分析 MRI 图像。通过将 DHI 与生物标志物以及传统 MRI 与组织病理学黄金进行比较 前瞻性地标准（活检），我们将确定 DHI 是否可以用于无创诊断和 监测前列腺癌；因此，支持 DHI 的临床转化作为侵入性的替代方案 活检。