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

项目摘要/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 胰腺癌将提出研究评估非侵入性方法来检测和量化 胰腺纤维化。在标准的影像研究中，脑性瘫痪可能缺乏特征性特征。初步 数据表明，磁共振成像(MRI)的某些特征目前未在临床上使用 练习(T1弛豫时间、细胞外体积[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])是有用的 用于CP的诊断。然而，在正常受试者或有明确CP的受试者中，数据有限。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，即使在CP的早期阶段 这种疾病。我们提出以下具体目标(SA)来实现这一目标，所有患者都将 从该财团的“继续”研究中招募。SA#1：作为主端点，我们将评估 胰腺实质T1松弛特性在评估CP中T1映射中的作用。 这项研究将首次测量无胰腺患者胰腺的正常T1弛豫时间。 疾病控制中心。作为次要终点，我们将评估T1加权梯度回波SIR、ECV分数、 动-静脉强化比、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、充盈缺陷、侧支扩张)和胰腺外分泌量 在分泌素刺激后。这将是第一个评估ECV分数的前瞻性研究，也是 在表型良好的患者组中进行胰腺MR弹性成像的综合研究 和其他成像功能。SA#2：我们将合并来自主端点和辅助端点的结果 以生成一个综合评分系统。我们将演示增加的功能数量将 与诊断为进展期或确诊性慢性胰腺炎相关，具有较高的敏感性和特异性。此外， 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 胰腺纤维化的量化标志物。最后，作为探索性目标，我们将获得试点数据 在60名疑似CP患者中，评估与SA#1相同的技术、参数和终点 和#2。这些数据将允许计算样本量，用于未来更大规模的研究，评估 疑似脑性瘫痪与确诊脑性瘫痪的MRI表现。我们建议MRI可作为评估疾病的生物标志物。 进展，利用接受后续MR评估的患者的子集。

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.