[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05659147":3,"trial-entities:NCT05659147":144,"trial-summary:NCT05659147":153},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":69,"secondary_outcomes":89,"sex":90,"minimum_age":91,"maximum_age":92,"healthy_volunteers":93,"eligibility_criteria":94,"std_ages":124,"locations":127,"central_contacts":137,"overall_officials":138,"references":142,"see_also_links":143},"NCT05659147","2022-0779","Imaging Biomarkers of Pancreatic Function and Disease","ENROLLING_BY_INVITATION","2027-12","2025-09","2026-03-18","2023-01-18","Children's Hospital Medical Center, Cincinnati","OTHER",false,"This study seeks to understand the performance of MRI to characterize pancreatitis and predict chronic complications (endocrine and exocrine) of pancreatitis. Through multiple aims, the investigators will benchmark MRI against relevant reference standards (e.g. endoscopic pancreatic function tests, laboratory data). The investigators will also characterize repeatability of the imaging findings and will work to develop methods to simplify and automate analysis of the MRI images.\n\nResearch interventions depend on the Aim(s) participants enroll in but include: endoscopic pancreatic function testing (added on to clinically indicated upper GI endoscopy), blood tests, stool tests, gene sequencing, and survey completion. All participants will undergo research MRI examinations, a subset of which will include administration of intravenous secretin.","Pancreatitis can be acute \\[AP\\], acute recurrent \\[ARP\\] (defined as two discrete attacks with interval resolution), or chronic \\[CP\\]. Adult studies show that up to 40% of patients develop abnormal glucose metabolism after a single attack of AP, with a 2.5x increased risk of diabetes. CP is defined, in part, by the presence of established endocrine (diabetes) or exocrine pancreatic insufficiency \\[EPI\\]. Currently, it is not possible to non-invasively diagnose or predict development of pancreatitis-related endocrine or exocrine insufficiency.\n\nThe investigator's data has shown that CFTR gene variants play a significant role in progression to diabetes post first attack AP. Existing literature suggests that imaging findings such as decreased pancreas volume are associated with diabetes, but this has not been systematically studied in children.\n\nEPI, defined as insufficient secretion of digestive enzymes and fluid by the pancreas, can have significant effects in childhood including malnutrition, osteoporosis, and growth failure. If diagnosed early, EPI can be treated with pancreatic enzyme replacement, improving nutrition and stabilizing growth. Unfortunately, diagnosing EPI early and accurately is a challenge in children and it is currently not possible to predict progression to CP or development of EPI.\n\nMagnetic resonance imaging (MRI) is a powerful, non-invasive technique, capable of characterizing pancreatic disease. Quantitative non-contrast MRI techniques are attractive as potential markers of pancreatic disease but they have not been validated for diagnosis or prediction of diabetes or EPI in children and they have not been explored for staging of pediatric pancreatitis.\n\nThe overall goals of this study are to:\n\n1. Define associations between non-invasive, quantitative MRI measures and established measures of pancreas health and function including diabetes and EPI in children\n2. Identify clinical, genetic and imaging-related factors that predict progression to diabetes in children with pancreatitis.",[18,19],"Pancreatitis","Diabetes Mellitus",[21],"MRI","INTERVENTIONAL","DIAGNOSTIC",[25],"PHASE4",{"count":27,"type":28},195,"ESTIMATED",[30,36,43,48,52,56,60,64],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIAGNOSTIC_TEST","Research MRI without administration of intravenous secretin","Participants will undergo a research MRI examination. MRI images will be quantitatively analyzed and will be compared to \u002F used to predict diabetes.",[35],"Imaging markers of diabetes and prediction of progression to diabetes",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Research MRI with administration of intravenous secretin","Participants will undergo a research MRI examination with intravenous administration of secretin. MRI images will be quantitatively analyzed and will be compared to \u002F used to predict exocrine and endocrine pancreatic insufficiency based on the reference standards of ePFTs or fecal elastase and blood hemoglobin A1c (HbA1c) and fasting glucose, respectively.",[40,41,42],"Imaging markers of exocrine and endocrine insufficiency","Imaging reproducibility","Imaging stratification of stages of pancreatitis",{"type":44,"name":45,"description":46,"armGroupLabels":47},"GENETIC","Genetic Sequencing","Blood will be drawn to enable gene sequencing for gene mutations associated with heritable pancreatitis. We will assess the association between identified gene variants and the presence of diabetes and will construct models based on identified variants to predict progression to diabetes.",[35],{"type":31,"name":49,"description":50,"armGroupLabels":51},"Blood Tests","Research blood draw (for markers of pancreatic endocrine insufficiency)",[35,40,42],{"type":31,"name":53,"description":54,"armGroupLabels":55},"Stool Tests","Research stool collection (for fecal elastase as a marker of exocrine insufficiency)",[40,42],{"type":13,"name":57,"description":58,"armGroupLabels":59},"Survey Completion","Participants will be contacted to complete a survey and their charts will be reviewed annually after research MRI to identify any evidence of subsequent development of pancreatic endocrine insufficiency or progression of pancreatitis. Survey and chart review will occur within +\u002F- 14 days of the anniversary date.",[35,40,42],{"type":31,"name":61,"description":62,"armGroupLabels":63},"Endoscopic pancreatic function tests (ePFTs)","At least two duodenal fluid aspirates will be collected over 15 minutes following secretin administration. Aspirates will be immediately pH tested and will be submitted for analysis of bicarbonate, enzyme (trypsin, amylase, lipase, chymotrypsin) activity, and total protein.",[40],{"type":65,"name":66,"description":67,"armGroupLabels":68},"DRUG","Secretin","Participants enrolled in Aim 1, Aim 3, and Aim 4 will receive intravenous secretin at a dose of 0.2 mcg\u002Fkg (maximum 16 mcg).\n\nParticipants in Aim 1 will receive two doses (1 during endoscopy and 1 during MRI). Participants in Aim 3 will receive one dose during MRI.\n\nParticipants in Aim 4 will receive two doses (1 during each MRI).\n\nSecretin for intravenous use is FDA-approved for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction. Safety and effectiveness of secretin in pediatrics have not been established. However, secretin is routinely used in children at CCHMC at the same dose at which it will be administered for this study.",[40,41,42],[70,74,76,79,81,84,86],{"measure":71,"description":72,"timeFrame":73},"Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).","2 x 2 table analyses of pancreas volume (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)","5 years",{"measure":71,"description":75,"timeFrame":73},"2 x 2 table analyses of pancreas volume (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)",{"measure":77,"description":78,"timeFrame":73},"Pancreas T1 signal as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).","2 x 2 table analyses of pancreas T1 signal (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)",{"measure":77,"description":80,"timeFrame":73},"2 x 2 table analyses of pancreas T1 signal intensity (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)",{"measure":82,"description":83,"timeFrame":73},"Pancreas secreted fluid volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).","2 x 2 table analyses of pancreas secreted fluid volume (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)",{"measure":82,"description":85,"timeFrame":73},"2 x 2 table analyses of pancreas secreted fluid volume (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)",{"measure":87,"description":88,"timeFrame":73},"Frequency of genetic mutations in patients progressing to diabetes vs. those not","Frequency of genetic mutations in each study group will be compared using 2x2 tables to identify mutations associated with development of diabetes",[],"ALL","5 Years","21 Years",true,{"inclusion":95,"exclusion":105,"raw_text":123},[96,97,98,96,97,96,99,96,100,96,101,96,99,96,102,96,103,96,104],"Age 5 to \\\u003C21 years","Scheduled for clinically-indicated gastrointestinal endoscopy","Clinical diagnosis or suspicion of exocrine pancreatic insufficiency","Clinically documented episode of acute pancreatitis","Clinical diagnosis of acute recurrent pancreatitis","Clinical diagnosis of pancreatitis-related diabetes","Clinical diagnosis of acute recurrent pancreatitis with no evidence of CP or EPI","Clinical diagnosis of chronic pancreatitis","Completed research MRI under Aims 1 or 3 of this study",[106,107,108,109,110,111,112,113,114,106,107,108,109,110,111,115,107,108,109,111,107,108,109,111,107,108,109,111,112,113,116,108,109,110,111,115,107,108,109,110,111,107,108,109,110,111,107,108,109,110,111,117,118,119,120,108,109,110,111,121,122],"Complete fatty replacement of pancreas on prior imaging","Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI","Need for sedation for MRI","Contraindication to MRI (implanted metal hardware)","Allergy to secretin","Pregnancy","Sweat chloride \\>60 mmol\u002FL","Clinical diagnosis of gastrointestinal pathology","Clinical diagnosis or history of pancreatic disease","More than one episode of acute pancreatitis","Clinical diagnosis or history of pancreatic disease, including acute pancreatitis","Failed\u002Funable to complete first research MRI under Aims 1 or 3","Episode of acute pancreatitis since first research MRI","Current acute pancreatitis","Any gastrointestinal surgery or pancreas intervention (e.g. ERCP) since first research MRI","Severe image artifact compromising image quality (judgement of study team)","Age \\>21 years","Aim 1-\n\nPatient Group:\n\nInclusion Criteria:\n\n* Age 5 to \\\u003C21 years\n* Scheduled for clinically-indicated gastrointestinal endoscopy\n* Clinical diagnosis or suspicion of exocrine pancreatic insufficiency\n\nExclusion Criteria:\n\n* Complete fatty replacement of pancreas on prior imaging\n* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI\n* Need for sedation for MRI\n* Contraindication to MRI (implanted metal hardware)\n* Allergy to secretin\n* Pregnancy\n\nControl Group:\n\nInclusion Criteria:\n\n* Age 5 to \\\u003C21 years\n* Scheduled for clinically-indicated gastrointestinal endoscopy\n\nExclusion Criteria:\n\n* Sweat chloride \\>60 mmol\u002FL\n* Clinical diagnosis of gastrointestinal pathology\n* Clinical diagnosis or history of pancreatic disease\n* Complete fatty replacement of pancreas on prior imaging\n* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI\n* Need for sedation for MRI\n* Contraindication to MRI (implanted metal hardware)\n* Allergy to secretin\n* Pregnancy\n\nAim 2-\n\nAcute Pancreatitis Group:\n\nInclusion Criteria:\n\n* Age 5 to \\\u003C21 years\n* Clinically documented episode of acute pancreatitis\n\nExclusion Criteria:\n\n* More than one episode of acute pancreatitis\n* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI\n* Need for sedation for MRI\n* Contraindication to MRI (implanted metal hardware)\n* Pregnancy\n\nAcute Recurrent Pancreatitis Group:\n\nInclusion Criteria:\n\n* Age 5 to \\\u003C21 years\n* Clinical diagnosis of acute recurrent pancreatitis\n\nExclusion Criteria:\n\n* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI\n* Need for sedation for MRI\n* Contraindication to MRI (implanted metal hardware)\n* Pregnancy\n\nPancreatitis-Related Diabetes Group:\n\nInclusion Criteria:\n\n* Age 5 to \\\u003C21 years\n* Clinical diagnosis of pancreatitis-related diabetes\n\nExclusion Criteria:\n\n* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI\n* Need for sedation for MRI\n* Contraindication to MRI (implanted metal hardware)\n* Pregnancy\n\nAim 3-\n\nControl Group:\n\nInclusion Criteria:\n\n• Age 5 to \\\u003C21 years\n\nExclusion Criteria:\n\n* Sweat chloride \\>60 mmol\u002FL\n* Clinical diagnosis of gastrointestinal pathology\n* Clinical diagnosis or history of pancreatic disease, including acute pancreatitis\n* Need for sedation for MRI\n* Contraindication to MRI (implanted metal hardware)\n* Allergy to secretin\n* Pregnancy\n\nAcute Pancreatitis Group:\n\nInclusion Criteria:\n\n* Age 5 to \\\u003C21 years\n* Clinically documented episode of acute pancreatitis\n\nExclusion Criteria:\n\n* More than one episode of acute pancreatitis\n* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI\n* Need for sedation for MRI\n* Contraindication to MRI (implanted metal hardware)\n* Allergy to secretin\n* Pregnancy\n\nAcute Recurrent Pancreatitis Group:\n\nInclusion Criteria:\n\n* Age 5 to \\\u003C21 years\n* Clinical diagnosis of acute recurrent pancreatitis with no evidence of CP or EPI\n\nExclusion Criteria:\n\n* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI\n* Need for sedation for MRI\n* Contraindication to MRI (implanted metal hardware)\n* Allergy to secretin\n* Pregnancy\n\nChronic Pancreatitis Group:\n\nInclusion Criteria:\n\n* Age 5 to \\\u003C21 years\n* Clinical diagnosis of chronic pancreatitis\n\nExclusion Criteria:\n\n* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI\n* Need for sedation for MRI\n* Contraindication to MRI (implanted metal hardware)\n* Allergy to secretin\n* Pregnancy\n\nAim 4-\n\nInclusion Criteria:\n\n* Age 5 to \\\u003C21 years\n* Completed research MRI under Aims 1 or 3 of this study\n\nExclusion Criteria:\n\n* Failed\u002Funable to complete first research MRI under Aims 1 or 3\n* Episode of acute pancreatitis since first research MRI\n* Current acute pancreatitis\n* Any gastrointestinal surgery or pancreas intervention (e.g. ERCP) since first research MRI\n* Need for sedation for MRI\n* Contraindication to MRI (implanted metal hardware)\n* Allergy to secretin\n* Pregnancy\n\nAim 5-\n\nInclusion Criteria:\n\n• MRI performed at CCHMC\n\nExclusion Criteria:\n\n* Severe image artifact compromising image quality (judgement of study team)\n* Age \\>21 years",[125,126],"CHILD","ADULT",[128],{"facility":129,"city":130,"state":131,"zip":132,"country":133,"geoPoint":134},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229","United States",{"lat":135,"lon":136},39.12711,-84.51439,[],[139],{"name":140,"affiliation":12,"role":141},"Andrew Trout, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":145,"biomarkers":152},[146,147,148,149,18,150,151],"Acute Pancreatitis","Chronic Pancreatitis","Gastrointestinal Polyp","Pancreatic Insufficiency","Pancreatitis-Related Diabetes","Recurrent Acute Pancreatitis",[],{"nct_id":4,"found":14,"summary":154,"prompt_version":154},null]