Data Coordinating Center for the Type 1 Diabetes in Acute Pancreatitis Consortium

急性胰腺炎联盟 1 型糖尿病数据协调中心

• 批准号: 10471067
• 负责人: Vernon M Chinchilli
• 金额: $ 176.91万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-17 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10471067
• 关键词: 3-Dimensional; Agreement; Artificial Intelligence; Atrophic; Biological Markers; Certification; Clinical Trials; Collection; Complication; Data; Data Analyses; Data Collection; Data Coordinating Center; Diabetes Mellitus; Early Diagnosis; Eligibility Determination; Endocrinologist; Enrollment; Evaluation; Evolution; Exocrine pancreatic insufficiency; Eye; Fatty acid glycerol esters; Funding; Gastroenterologist; Goals; Human; Image; Image Analysis; Imaging Techniques; Individual; Infiltration; Institutional Review Boards; Insulin-Dependent Diabetes Mellitus; Knowledge; Laboratories; Location; Longitudinal Studies; Magnetic Resonance Imaging; Manuscripts; Measurement; Measures; Metabolic; Metabolic dysfunction; Monitor; Morphology; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Pancreas; Pancreatic Diseases; Participant; Pathogenesis; Patients; Perfusion; Persons; Phenotype; Policies; Population; Prediabetes syndrome; Preparation; Process; Prospective Studies; Protocols documentation; Psoas Muscles; Publications; Reporting; Research Design; Risk; Risk Assessment; Safety; Sample Size; Serial Magnetic Resonance Imaging; Services; Shapes; Signal Transduction; Staging; Standardization; Statistical Data Interpretation; Testing; Texture; Training; Visit; acute pancreatitis; arm; clinical center; clinical practice; cyber security; data exchange; data management; deep learning algorithm; diabetic patient; experience; extracellular; follow-up; image archival system; image reconstruction; imaging biomarker; non-invasive imaging; pancreas imaging; radiologist; risk stratification; sarcopenia; tool

PROJECT SUMMARY / ABSTRACT According to recent reports, pancreatogenic DM, a known complication of acute pancreatitis, may occur more frequently than previously recognized. Currently, limited data exist on well-phenotyped post-AP subjects from prospective studies to confirm this information. The Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC) was formed in 2020 to fulfill this knowledge gap (RFA-DK-19-023). The primary longitudinal study of the T1DAPC is the DREAM study which is funded and will begin enrolling patients in September 2021. The IMMINENT study is being proposed as the imaging biomarker arm of the DREAM study. Patients who experienced AP will enroll in the DREAM study and a subset of those participants will enroll in the IMMINENT study to have serial MRI examinations at 3, 12, 24 and 33 months. Preliminary data suggest that certain features on MRI not currently used in clinical practice can be useful in risk the assessment of DM. The hypothesis of the IMMINENT is that by identifying parenchymal changes in post-AP patients, MR imaging can differentiate at-risk individuals from those who will remain euglycemic. To achieve this goal, we will use several quantitative MR imaging techniques to interrogate the parenchyma. In addition to the advanced MRI analysis, we will use artificial intelligence and deep learning algorithms to detect changes that are not visible to the human eye. Our purpose is to observe and understand the natural history of DM after AP and demonstrate that MR imaging can reflect underlying pathophysiologic changes and serve as a biomarker of DM. We believe data generated from IMMINENT will enhance our understanding of the pathogenesis of post-AP DM. If successful, we will develop a quantitative composite risk score using useful MRI features. This composite risk score can be used for monitoring the risk of metabolic dysfunction in practice or clinical trials. As part of the T1DAPC (a multicenter collaborative network), we propose an excellent opportunity to investigate the post-AP DM by incorporating dedicated pancreas radiologists, gastroenterologists, endocrinologists, a data coordinating center, MR image analysis, and AI labs.

项目摘要 /摘要 根据最近的报道，胰腺生成DM是已知的急性胰腺炎并发症，可能发生更多 通常比以前认可的。目前，在良好的拟型后AP主题上存在有限的数据 前瞻性研究以确认此信息。急性胰腺炎联盟（T1DAPC）中的1型糖尿病 成立于2020年以满足这一知识差距（RFA-DK-19-023）。 T1DAPC的主要纵向研究 是资助的梦想研究，将于2021年9月开始入学。迫在眉睫的研究 被提议为梦想研究的成像生物标志物。经历过AP的患者将注册 在梦中的研究和这些参与者的子集中 3、12、24和33个月的考试。初步数据表明MRI上的某些功能目前不是 在临床实践中使用可用于评估DM的风险。迫在眉睫的假设是 识别AP后患者的实质性变化，MR成像可以将高危个体与那些分化 谁将保持尤利科。为了实现这一目标，我们将使用几种定量的MR成像技术来 询问实质。除了高级MRI分析外，我们还将使用人工智能和深层 学习算法以检测人眼看不到的变化。我们的目的是观察和 了解AP后DM的自然历史，并证明MR成像可以反映基础 病理生理变化并充当DM的生物标志物。我们认为迫在眉睫的数据将 增强我们对后DM发病机理的理解。如果成功，我们将开发一个定量 使用有用的MRI功能的综合风险评分。此综合风险评分可用于监视 实践或临床试验中的代谢功能障碍。作为T1DAPC（多中心协作网络）的一部分， 我们提出了一个绝佳的机会，通过合并专用胰腺来调查后DM 放射科医生，胃肠病学家，内分泌学家，数据协调中心，MR图像分析和AI实验室。