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Enrolling By Invitation
NCT05659147
Imaging Biomarkers of Pancreatic Function and Disease
Conditions: Pancreatitis, Diabetes Mellitus
Sex: All
Ages: 5 Years – 21 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 195
Sponsor: Children's Hospital Medical Center, Cincinnati
Location: United States
Summary
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.Research 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.
Eligibility Criteria
Aim 1-Patient Group:Inclusion Criteria:Age 5 to <21 yearsScheduled for clinically-indicated gastrointestinal endoscopyClinical diagnosis or suspicion of exocrine pancreatic insufficiencyExclusion Criteria:Complete fatty replacement of pancreas on prior imagingCurrent acute pancreatitis or acute pancreatitis less than 30 days prior to research MRINeed for sedation for MRIContraindication to MRI (implanted metal hardware)Allergy to secretinPregnancyControl Group:Inclusion Criteria:Age 5 to <21 yearsScheduled for clinically-indicated gastrointestinal endoscopyExclusion Criteria:Sweat chloride >60 mmol/LClinical diagnosis of gastrointestinal pathologyClinical diagnosis or history of pancreatic diseaseComplete fatty replacement of pancreas on prior imagingCurrent acute pancreatitis or acute pancreatitis less than 30 days prior to research MRINeed for sedation for MRIContraindication to MRI (implanted metal hardware)Allergy to secretinPregnancyAim 2-Acute Pancreatitis Group:Inclusion Criteria:Age 5 to <21 yearsClinically documented episode of acute pancreatitisExclusion Criteria:More than one episode of acute pancreatitisCurrent acute pancreatitis or acute pancreatitis less than 30 days prior to research MRINeed for sedation for MRIContraindication to MRI (implanted metal hardware)PregnancyAcute Recurrent Pancreatitis Group:Inclusion Criteria:Age 5 to <21 yearsClinical diagnosis of acute recurrent pancreatitisExclusion Criteria:Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRINeed for sedation for MRIContraindication to MRI (implanted metal hardware)PregnancyPancreatitis-Related Diabetes Group:Inclusion Criteria:Age 5 to <21 yearsClinical diagnosis of pancreatitis-related diabetesExclusion Criteria:Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRINeed for sedation for MRIContraindication to MRI (implanted metal hardware)PregnancyAim 3-Control Group:Inclusion Criteria:• Age 5 to <21 yearsExclusion Criteria:Sweat chloride >60 mmol/LClinical diagnosis of gastrointestinal pathologyClinical diagnosis or history of pancreatic disease, including acute pancreatitisNeed for sedation for MRIContraindication to MRI (implanted metal hardware)Allergy to secretinPregnancyAcute Pancreatitis Group:Inclusion Criteria:Age 5 to <21 yearsClinically documented episode of acute pancreatitisExclusion Criteria:More than one episode of acute pancreatitisCurrent acute pancreatitis or acute pancreatitis less than 30 days prior to research MRINeed for sedation for MRIContraindication to MRI (implanted metal hardware)Allergy to secretinPregnancyAcute Recurrent Pancreatitis Group:Inclusion Criteria:Age 5 to <21 yearsClinical diagnosis of acute recurrent pancreatitis with no evidence of CP or EPIExclusion Criteria:Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRINeed for sedation for MRIContraindication to MRI (implanted metal hardware)Allergy to secretinPregnancyChronic Pancreatitis Group:Inclusion Criteria:Age 5 to <21 yearsClinical diagnosis of chronic pancreatitisExclusion Criteria:Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRINeed for sedation for MRIContraindication to MRI (implanted metal hardware)Allergy to secretinPregnancyAim 4-Inclusion Criteria:Age 5 to <21 yearsCompleted research MRI under Aims 1 or 3 of this studyExclusion Criteria:Failed/unable to complete first research MRI under Aims 1 or 3Episode of acute pancreatitis since first research MRICurrent acute pancreatitisAny gastrointestinal surgery or pancreas intervention (e.g.
ERCP) since first research MRINeed for sedation for MRIContraindication to MRI (implanted metal hardware)Allergy to secretinPregnancyAim 5-Inclusion Criteria:• MRI performed at CCHMCExclusion Criteria:Severe image artifact compromising image quality (judgement of study team)Age >21 years
Source: ClinicalTrials.gov (NCT05659147). StuddyBuddy aggregates publicly available trial information.
