Magnetic resonance Imaging as a Non-Invasive Method for Assessment of Pancreatic fibrosis (MINIMAP): a pilot study

磁共振成像作为评估胰腺纤维化的非侵入性方法 (MINIMAP)：一项试点研究

• 批准号: 9788429
• 负责人: Evan L Fogel
• 金额: $ 63.8万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-20 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9788429
• 关键词: Atrophic; Biological Markers; Characteristics; Clinical; Data; Defect; Diabetes Mellitus; Diagnosis; Diagnostic Imaging; Diagnostic tests; Diffusion; Diffusion Magnetic Resonance Imaging; Disease; Disease Progression; Duct (organ) structure; Ductal; Duodenum; Early Diagnosis; Enrollment; Evaluation; Evaluation Studies; Exocrine pancreas; Fatty acid glycerol esters; Fibrosis; Future; Image; Imaging Techniques; Magnetic Resonance Imaging; Malignant neoplasm of pancreas; Measures; Methods; Output; Pancreas; Pancreatic Diseases; Patients; Phenotype; Pilot Projects; Property; Prospective Studies; Relaxation; Role; Sample Size; Secretin; Sensitivity and Specificity; Side; Signal Transduction; Specificity; Surrogate Markers; System; Techniques; Time; chronic pancreatitis; clinical practice; disorder control; elastography; extracellular; follow-up; imaging study; patient subsets; primary endpoint; recruit; secondary endpoint; tool

PROJECT SUMMARY/ABSTRACT One of the defined objectives of the consortium for the study of Chronic Pancreatitis (CP), Diabetes and Pancreatic Cancer is to propose studies evaluating non-invasive methods to detect and quantify pancreatic fibrosis. Characteristic features of CP may be absent on standard imaging studies. Preliminary data suggest that certain features on Magnetic Resonance Imaging (MRI) not currently used in clinical practice (T1 relaxation time, extracellular volume [ECV] fraction, T1-weighted gradient echo signal intensity ratio [SIR], diffusion-weighted imaging [DWI] and apparent diffusion coefficient [ADC]) are useful for the diagnosis of CP. However, limited data exist in normal subjects or those with definite CP. We hypothesize that MRI can serve as a valuable non- invasive tool to detect CP, even in the early stages of the disease. We propose the following specific aims (SA) to meet this objective, with all patients to be recruited from the consortium’s “PROCEED” study. SA#1: As the primary endpoint, we will evaluate the role of T1 relaxation properties of the pancreatic parenchyma on T1 mapping in the assessment of CP. This study will be the first to measure the normal T1 relaxation time of the pancreas in no pancreas disease controls. As secondary endpoints, we will evaluate T1-weighted gradient echo SIR, ECV fraction, arterio-venous enhancement ratio, ADC, MR elastography, volume/atrophy, pancreatic steatosis, ductal features (narrowing/stricture, dilation, filling defects, side branch dilation) and pancreatic exocrine output after secretin stimulation. This will be the first prospective study to evaluate ECV fraction, and the most comprehensive study performed in well-phenotyped groups of patients for pancreatic MR elastography and other imaging features. SA#2: We will combine the results from the primary and secondary endpoints to generate a composite scoring system. We will demonstrate that an increased number of features will correlate with a diagnosis of advanced or definite CP with higher sensitivityand specificity. Furthermore, we anticipate that cumulative MRI features may allow the diagnosis of early CP and serve as a surrogate marker for the quantification of pancreatic fibrosis. Lastly, as an exploratory aim, we will obtain pilot data in 60 patients with suspected CP, evaluating the same techniques, parameters, and endpoints as in SA#1 and #2. These data will allow for sample size calculation for a future larger study evaluating the role of MRI in suspected vs. definite CP. We propose that MRI may be used as a biomarker to assess disease progression, utilizing a subset of patients who undergo follow-up MR evaluation.

项目总结/摘要 慢性胰腺炎（CP）、糖尿病和糖尿病研究联盟的明确目标之一是 胰腺癌是建议研究评估非侵入性方法，以检测和量化 胰腺纤维化CP的特征性特征在标准影像学检查中可能不存在。初步 数据表明，磁共振成像（MRI）的某些功能目前未用于临床 实践（T1弛豫时间，细胞外容积[ECV]分数，T1加权梯度回波信号 强度比[SIR]、扩散加权成像[DWI]和表观扩散系数[ADC CP的诊断。然而，有限的数据存在于正常受试者或那些明确的CP。我们 假设MRI可以作为一种有价值的非侵入性工具来检测CP，即使是在早期阶段， 这种疾病我们提出了以下具体目标（SA）来实现这一目标，所有患者都将 从财团的“PROCEED”研究中招募。SA#1：作为主要终点，我们将评估 胰腺实质的T1弛豫特性在CP评估中对T1标测的作用。 这项研究将是第一个测量正常的T1弛豫时间的胰腺，没有胰腺 疾病控制。作为次要终点，我们将评价T1加权梯度回波SIR、ECV分数， 动静脉增强比，ADC，MR弹性成像，体积/萎缩，胰腺脂肪变性，导管 特征（狭窄/狭窄、扩张、充盈缺损、侧分支扩张）和胰腺外分泌量 分泌素刺激后。这将是第一个评估ECV分数的前瞻性研究， 在胰腺MR弹性成像的良好表型患者组中进行的综合研究 以及其他成像特征。SA #2：我们将联合收割机合并主要和次要终点的结果 以生成复合评分系统。我们将证明，更多的功能将 与晚期或确诊CP的诊断相关，具有较高的敏感性和特异性。此外，委员会认为， 我们预计，累积的MRI特征可能有助于早期CP的诊断，并可作为替代品。 胰腺纤维化的定量标志物。最后，作为探索性目标，我们将获得试点数据 在60例疑似CP患者中，评价与SA#1相同的技术、参数和终点 #2。这些数据将允许为未来更大规模的研究计算样本量，以评估 疑似与确诊CP的MRI。我们建议MRI可以作为评估疾病的生物标志物 进展，利用接受随访MR评价的患者子集。