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; 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.

项目摘要/摘要 慢性胰腺炎（CP），糖尿病和 胰腺癌是提出评估非侵入性方法来检测和量化的研究 胰腺纤维化。在标准成像研究中可能不存在CP的特征。初步的 数据表明，磁共振成像（MRI）当前未用于临床的某些特征 练习（T1放松时间，细胞外体积[ECV]分数，T1加权梯度回声信号 强度比[SIR]，扩散加权成像[DWI]和明显的扩散系数[ADC]）是有用的 用于诊断CP。但是，正常受试者或具有定义的CP的数据中存在有限的数据。我们 假设MRI可以作为检测CP的有价值的非侵入性工具，即使在 疾病。我们提出以下特定目标（SA）来满足这一目标，所有患者均为 从财团的“继续”研究中招募。 SA＃1：作为主要终点，我们将评估 胰腺实质在CP评估中T1弛豫特性在T1映射中的作用。 这项研究将是第一个在无胰腺中测量胰腺正常松弛时间的一项 疾病控制。作为次要端点，我们将评估T1加权梯度回波先生，ECV分数， 动脉预期增强比，ADC，MR弹性学，体积/萎缩，胰腺脂肪变性，导管 功能（狭窄/狭窄，扩散，填充缺陷，侧支分支扩散）和胰腺外分泌输出 分泌蛋白刺激后。这将是评估ECV分数的第一项前瞻性研究，也是最多的研究 在胰腺MR弹性术的患者组中进行的全面研究 和其他成像功能。 SA＃2：我们将结合主要和次要端点的结果 生成复合评分系统。我们将证明更多功能将会 与具有更高灵敏度和特异性的高级或定义CP的诊断相关。此外， 我们预计累积MRI特征可能允许诊断早期CP并用作替代物 定量胰腺纤维化的标记。最后，作为探索目的，我们将获得飞行员数据 在60例可疑CP的患者中，评估与SA＃1相同的技术，参数和终点 和＃2。这些数据将允许对未来的大型研究进行样本量计算，以评估 MRI在可疑与定义的CP中。我们建议MRI可以用作评估疾病的生物标志物 进展，使用接受随访MR评估的患者的子集。