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: 10544153
• 负责人: Joseph Edward Ippolito
• 金额: $ 58.12万
• 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/10544153
• 关键词: Address; Benign; Benign Prostatic Hypertrophy; Biological Markers; Biopsy; Blood; Blood Tests; Cancer Patient; Classification; Clinical; Data; Diagnosis; Diagnostic; Diffusion; Disease Progression; Extraprostatic; General Population; Gleason Grade for Prostate Cancer; Goals; Histology; Hospitalization; Image; Indolent; Interdisciplinary Study; Invaded; Liquid substance; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Methods; Modeling; Monitor; Nomograms; Non-Invasive Detection; Operative Surgical Procedures; PSA screening; Pathologic; Pathology; Patient Selection; Patients; Periodicals; Procedures; Prostate; Prostate-Specific Antigen; Prostatectomy; Prostatic Diseases; Protocols documentation; Radiation; Radical Prostatectomy; Rectum; Reference Standards; Risk; Seminal Vesicles; Sensitivity and Specificity; Sepsis; Testing; Tissues; Training; United States; Update; Urine; Visualization; accurate diagnosis; artificial intelligence algorithm; cancer diagnosis; clinical care; clinical imaging; clinical risk; clinical translation; clinically significant; cohort; disorder risk; high risk; improved; magnetic resonance imaging biomarker; men; non-invasive monitor; noninvasive diagnosis; novel; overtreatment; patient screening; patient subsets; performance tests; prospective; prostate biopsy; prostate cancer risk; prostatitis; recruit; rectal; 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 目前的前列腺癌（PCa）诊断方法存在明显的局限性。的大约一半 接受经直肠前列腺活检的男性，这是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-未发现有PCa。对于那些有PCa的人来说，许多人都是懒惰的， 最好通过主动监测（AS）进行管理的癌症，由于存在严重的癌症风险， 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）已被 越来越多地被用来解决这个问题。然而，目前可用的工具并不准确 足以单独或组合以放弃活检。 我们开发了一种新的MRI序列（扩散基谱成像）和分析这些序列的方法。 扩散组织学成像（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 （癌症的存在和存在时的癌症等级）。我们的目标是将DHI应用于两种不同临床 设置：目标1，PSA筛查的初始活检，目标2，已知惰性PCa管理的重复活检 与AS。我们还计划在目标3中根据这些目标中获得的数据更新我们的DHI模型，然后 招募并在接受PSA筛查的独立患者组中测试更新的DHI模型。我们 假设DHI将允许PCa准确和非侵入性诊断，从而减少不必要的 活组织检查 在我们提出的研究中，这些男性将进行生物标志物检测，然后接受临床前列腺MRI检查。 （常规序列），在活检前添加DBSI成像协议。DBSI成像将 通过我们的DHI模型进行分析。请注意，DBSI协议只会增加几分钟， 临床MRI的总持续时间，不会显著影响患者或临床成像工作流程。在 与常规MRI解释和临床护理活检平行，我们的团队将对以下患者进行DHI分析： MRI图像。通过比较DHI与生物标志物和常规MRI与组织病理学金 标准（活检）的前瞻性方式，我们将确定DHI是否可以用于非侵入性诊断， 监测PCa;因此，支持DHI的临床转化，用作侵入性的替代方法 活组织检查