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Disposable Perfusion Phantom for Accurate DCE-MRI Measurement of Pancreatic Cancer Therapy Response

用于准确测量胰腺癌治疗反应的一次性灌注模型

基本信息

批准号：
10663915
负责人：
Harrison Kim
金额：
$ 44.06万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10663915
关键词：
Abdomen Address Adoption Anatomy Cancer Patient Clinic Clinical Clinical Trials Collaborations Computer software Contrast Media Data Data Analyses Devices Early identification Early treatment Error Sources Excision Feedback Goals Human Resources Image Individual Injections Institution Interobserver Variability Magnetic Resonance Imaging Malignant Neoplasms Malignant neoplasm of pancreas Measurement Measures Methodology Molds Multi-Institutional Clinical Trial Names Neoadjuvant Therapy Operative Surgical Procedures Outcome Participant Patients Perfusion Phase Reproducibility Research Institute Resectable Site Solid Neoplasm Speed Surrogate Markers System Technology Testing Time Tissues Treatment Protocols Update Variant cancer care chemotherapy clinical research site contrast enhanced cost effective therapy gastrointestinal image processing imaging biomarker improved invention large scale production manufacture multi-site trial operation pancreatic neoplasm patient stratification point of care portability precision medicine predictive marker programs prototype quality assurance radiologist recruit response tool treatment optimization treatment response tumor

项目摘要

PROJECT SUMMARY / ABSTRACT The overall goal of this study is to validate a UAB-invented perfusion phantom named P4 (Point-of-care Portable Perfusion Phantom) for accurate DCE-MRI measurement of pancreatic tumor response to neoadjuvant therapy. DCE-MRI has been utilized to noninvasively assess early therapeutic response in solid tumors by detecting changes in tissue perfusion prior to anatomic tumor shrinkage. However, measurement variability across different scanners remains a major concern in multi-site trials of DCE-MRI. To address this concern, we invented the P4 that is small enough to be imaged concurrently in the bore of a standard MRI scanner with a patient, thus can serve as an internal reference to detect and correct the scanner-dependent variation in quantitating DCE-MRI parameters. We have confirmed that the use of this device decreased variability in DCE-MRI measurement to about 4%, although it was about 20% before correction. We now hypothesize that the P4 can help identify early therapeutic response of pancreatic tumors in the neoadjuvant setting. Pancreatic tumors are typically hypo-perfused, but we have recently demonstrated that the tumor perfusion can be significantly increased after an effective chemotherapy. Choosing the more effective therapy early is particularly important for patients with borderline-resectable pancreatic cancer, as an effective therapy can downstage a tumor to allow curable surgery. Three specific aims are proposed as follows. Aim 1 (UG3- 1): Develop a disposable P4 that is concurrently imaged with a patient for improved accuracy and reproducibility in quantitative DCE-MRI measurement. For routine and widespread clinical use, the phantom should be ready-to-use, inexpensive and disposable. Injection molding methodology will be employed to manufacture the disposable P4. Aim 2 (UG3-2): Develop a software package analyzing abdominal DCE-MRI images obtained with the P4. Image processing will be conducted sequentially in eight steps. To date, we have developed eight prototype software program modules (one for each step). In this study, we aim to combine all eight modules for seamless data flow, while making each module automated/semi-automated not only to reduce user bias but to improve speed of operation. The software front panel will be updated for more efficient operation using feedback from multiple users. Aim 3 (UH3-1): Evaluate the changes of DCE-MRI parameters as surrogate imaging biomarkers for pancreatic cancer therapy response in a multi-site setting after error correction using the P4. A total of 50 patients with borderline resectable pancreatic cancer entering neoadjuvant therapy will be recruited in two research institutes (n=25 per institute). The changes of DCE-MRI parameters in tumors for 4 weeks after therapy initiation will be correlated with the therapeutic response assessed by margin-negative resection rate after completion of neoadjuvant therapy, and evaluated as surrogate biomarkers after P4-based error correction.

项目摘要/摘要这项研究的总体目标是验证UAB发明的名为P4(Point-of Care)的灌注模体便携式灌注体模)用于准确测量胰腺肿瘤对化疗的反应新辅助治疗。DCE-MRI已被用于无创评估固体药物的早期治疗反应通过在解剖肿瘤缩小之前检测组织灌注量的变化来检测肿瘤。然而，测量在DCE-MRI的多点试验中，不同扫描仪之间的可变性仍然是一个主要问题。要解决这个问题令人担忧的是，我们发明了P4，它足够小，可以在标准MRI的内孔中同时成像扫描仪与患者在一起，因此可以作为内部基准来检测和纠正扫描仪的依赖 DCE-MRI定量参数的变异。我们已经证实，该设备的使用减少了 DCE-MRI测量的变异性约为4%，尽管校正前约为20%。我们现在假设P4有助于识别新辅助治疗中胰腺肿瘤的早期治疗反应布景。胰腺肿瘤通常是低灌注的，但我们最近证明了肿瘤在有效的化疗后，血液灌注量可以显著增加。选择更有效的治疗方法作为一种有效的治疗方法，早期治疗对边界可切除的胰腺癌患者尤其重要。可以将肿瘤降级，以便进行可治愈的手术。提出三个具体目标如下。目标1(UG3- 1)：开发一种可与患者同时成像的一次性P4，以提高准确性和定量DCE-MRI测量的重复性。对于常规和广泛的临床应用，幻影应该是现成的、便宜的和一次性的。将采用注塑成型方法来制造一次性P4。目标2(UG3-2)：开发腹部DCE-MRI分析软件包使用P4获得的图像。图像处理将分八个步骤顺序进行。迄今为止，我们开发了八个原型软件程序模块(每个步骤一个)。在这项研究中，我们的目标是组合所有八个模块以实现无缝数据流，同时使每个模块不再自动化/半自动只是为了减少用户偏见，而是为了提高操作速度。软件前面板将进行更新以获得更多信息使用来自多个用户的反馈实现高效运营。目的3(UH3-1)：评价DCE-MRI的变化参数作为胰腺癌多部位治疗反应的替代成像生物标志物在使用P4进行纠错之后。50例边界可切除的胰腺癌患者进入新辅助治疗将在两个研究所(每个研究所25个)招募。DCE-MRI的改变治疗开始后4周的肿瘤参数将与治疗反应相关。根据新辅助治疗完成后切缘阴性切除率进行评估，并评估为基于P4的纠错后的替代生物标志物。