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.

项目摘要 当前的前列腺癌（PCA）诊断方法存在明显的局限性。大约一半 经历过直肠前列腺活检的男人 - 一种非常不舒服的侵入性手术 包括败血症在内的重大风险 - 未发现具有PCA。对于那些患有PCA的人，许多 最好通过主动监视（AS）来管理的癌症，该癌症需要每年的重复活检 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）已经 越来越多地试图解决这个问题。但是，当前可用的工具不准确 足够单独或结合在一起，可以忘记活检。 我们已经开发了一种新的MRI序列（扩散基频谱成像）和一种分析这些的方法 成像指标 - 扩散组织学成像（DHI） - 可能会克服常规MRI的局限性 解释。初步数据证明了DHI的高精度以预测前列腺活检结果 （存在癌症和癌症等级时）。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，PSA筛查的初始活检和AIM 2，重复用于已知不软体PCA的活检 与as。我们还计划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和测试更新的DHI模型。我们 假设DHI将允许对PCA进行准确和非侵入性诊断，从而减少不必要的 活检。 在我们提出的研究中，这些人将进行生物标志物测试，然后接受临床前列腺MRI （常规序列）在活检之前添加了DBSI成像协议。 DBSI成像将 请通过我们的DHI模型对收购后进行分析。请注意，DBSI协议只会在 临床MRI的总持续时间，不会显着影响患者或临床成像工作流程。 与常规MRI解释和每个临床护理活检平行，我们的团队将对DHI进行DHI分析 MRI图像。通过将DHI与生物标志物和常规MRI进行比较与组织病理学 标准（活检）以预期的方式，我们将确定是否可以使用DHI进行非侵袭性诊断和 监视PCA;因此，支持DHI的临床翻译用作侵入性的替代品 活检。