Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to enhance MRI diagnostic capabilities in Prostate Cancer

限制光谱成像信号图的验证、校准和转换，以增强前列腺癌的 MRI 诊断能力

• 批准号: 10639737
• 负责人: Michael Andre Liss
• 金额: $ 61.6万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-17 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10639737
• 关键词: Academic support; Affect; Amendment; Anatomy; Area; Area Under Curve; Biological Markers; Biopsy; Biopsy Specimen; Calibration; California; Characteristics; Clinical; Clinical Assessment Tool; Clinical Trials; Code; Color; Computer software; Data; Decision Making; Detection; Diagnosis; Diffusion; Diffusion Magnetic Resonance Imaging; Digital Imaging and Communications in Medicine; Disease; Early Diagnosis; Enrollment; Equipment; FDA approved; Health; High-Risk Cancer; Housing; Image; Image Analysis; Imaging technology; Indolent; Inflammation; Information Systems; Institution; Intravenous; Investigation; Lesion; Location; Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy; Magnetism; Malignant Neoplasms; Malignant neoplasm of prostate; Manufacturer; Maps; Measurement; Measures; Medicine; Methods; Modality; Modeling; Molds; Monitor; Output; Patients; Pharmaceutical Preparations; Predictive Value; Process; Prostate; Prostatectomy; Protocols documentation; Publishing; Radiology Specialty; Reader; Receiver Operating Characteristics; Reporting; Research; Restriction Spectrum Imaging; Sampling; Sampling Errors; Scanning; Screening for Prostate Cancer; Serum; Signal Transduction; Source; Specificity; Standardization; Statistical Data Interpretation; Structure; System; T2 weighted imaging; Techniques; Time; Tissues; Translating; Translations; Tumor Markers; United States; Urine; Validation; Variant; Vendor; Water; Work; arm; biomarker performance; cancer biomarkers; cancer cell; cancer diagnosis; clinical diagnosis; clinical practice; clinical risk; clinically significant; diagnostic accuracy; diagnostic value; diffusion weighted; imaging biomarker; imaging modality; improved; in vivo; indexing; industry partner; innovation; interest; intravenous injection; manufacture; men; molecular marker; non-invasive imaging; novel; prospective; prostate biopsy; prostate cancer cell; prostate cancer risk; radiologist; randomized, clinical trials; risk stratification; side effect; standard of care; tumor; ultrasound

Project Summary/Abstract Prostate cancer affects nearly 1 in 7 men in the United States yet the diagnosis of early aggressive cancer remains elusive at the expense of many unnecessary biopsies, delay in diagnosis from biopsy sampling error, or the diagnosis of indolent disease. In order make a diagnose clinically significant prostate cancer, there is an urgent need find an imaging modality that can be implemented uniformly, yet also provide clinical utility. MRI- guided prostate biopsy has rapidly become a common modality to perform prostate biopsy; however, limited emphasis has been placed on the quality and accuracy of the image acquisition. Our proposal supports an academic-industry partnership to develop and imaging biomarker that could revolutionize how prostate cancer is diagnosed and monitored by using restriction spectrum imaging (RSI)-MRI. We seek to improve the operating characteristics of prostate MRI with a novel, non-invasive method of a short- duration, targeted magnetic RSI-MRI sequences then undergo FDA-cleared, class II post-processing software (OnQ Prostate) to attribute values to suspicious areas of the prostate. RSI-MRI employs multiple b-value acquisitions with multiple diffusion gradient directions at each b-value to acquire raw data; images are post- processed to isolate the signal from isotropic, restricted water compartments typically found in cancer cells. A resultant “restricted signal map” corresponding to tumor location is derived and quantified functioning as an in vivo biomarker of tumor grade and enhances tumor conspicuity for reader detection. In Aim 1, weseek to validate our previous findings regarding the operating characteristics of the RSM values and its association with clinically significant prostate cancer (grade group 2 or higher). We will use a non-randomized, single arm clinical trial to investigate both PI-RADS scores with and without the RSM values. In Aim 2, we see to calibrate the RSM map values across manufacturers(Siemens, GE, and Phillips MRI scanners). We will use a two-scan approach which will invite a sample of men with a range of PI-RADS values to undergo a research reference scan after they have undergone their standard of care scan within one of three locations housing a specific MRI vendor. The two scans will be compared and used to calibrate the RSM values using several calibration and normalization techniques with targeted biopsy results. In some men that do undergo prostatectomy, we will further make a mold of the prostate using the preoperative MRI then perform whole-mount sectioning, scanning, and alignment with RSI-MRI to obtain accurate reads of normal and cancer areas. In Aim 3, we will compare RSM to currently available FDA-approved biomarkers and clinical risk to determine clinical utility. In the proposed project, we seek to improve specificity of prostate MRI using RSI. Specific deliverables will include the ability to amend the standard radiological reporting system (PI-RADS) withspecific RSM output vales. We seek to validate the restricted signal maps between vendors and provide clinical assessment tools demonstrating a measurement of clinical utility.

项目概要/摘要 在美国，近七分之一的男性患有前列腺癌，但诊断为早期侵袭性癌症 仍然难以捉摸，代价是许多不必要的活检、活检取样错误造成的诊断延误， 或惰性疾病的诊断 为了诊断具有临床意义的前列腺癌，需要进行一项检查。 迫切需要找到一种可以统一实施、同时又能提供临床实用性的成像方式。 引导活检已迅速成为一种常见的前列腺活检方式，但其局限性很大； 重点放在图像采集的质量和准确性上。 我们的提案支持学术界合作开发和成像生物标志物 使用限制性频谱成像 (RSI)-MRI 彻底改变前列腺癌的诊断和监测方式。 我们寻求通过一种新颖的、非侵入性的短时间方法来改善前列腺 MRI 的操作特性。 持续时间，目标磁性 RSI-MRI 序列然后经过 FDA 批准的 II 类后处理软件 (OnQ Prostate) 将值归因于前列腺的可疑区域。 在每个 b 值处进行多个扩散梯度方向的采集以获取原始数据； 经过处理以将信号与癌细胞 A 中常见的各向同性、受限的水区室隔离。 由此产生的与肿瘤位置相对应的“限制信号图”被导出并量化，作为一个in 肿瘤级别的体内生物标志物并增强读者检测的肿瘤显着性 在目标 1 中，我们寻求验证。 我们之前关于 RSM 值的操作特征及其与临床关联的发现 显着的前列腺癌（2级或更高级别）我们将使用非随机、单组临床试验来进行治疗。 研究具有和不具有 RSM 值的 PI-RADS 分数 在目标 2 中，我们将校准 RSM 图。 跨制造商（西门子、GE 和飞利浦 MRI 扫描仪）的值我们将使用两次扫描方法。 将邀请具有一系列 PI-RADS 值的男性样本在他们获得研究参考扫描后进行研究参考扫描 两人在特定 MRI 供应商所在的三个地点之一接受标准护理扫描。 扫描结果将被比较并用于使用多种校准和归一化来校准 RSM 值 对于一些接受前列腺切除术的男性，我们将进一步进行一项具有针对性活检结果的技术。 使用术前 MRI 制作前列腺模型，然后进行整体切片、扫描和对齐 使用 RSI-MRI 获得正常区域和癌症区域的准确读数 在目标 3 中，我们将 RSM 与当前进行比较。 可用 FDA 批准的生物标志物和临床风险来确定临床效用。 在拟议的项目中，我们寻求使用 RSI 提高前列腺 MRI 的特异性。 包括使用特定 RSM 输出值修改标准放射报告系统 (PI-RADS) 的能力。 我们寻求验证供应商之间的受限信号图并提供临床评估工具 展示临床效用的测量。