Imaging Biomarkers of Pancreatic Function and Disease
Pancreatitis, Diabetes Mellitus
About this trial
This is an interventional diagnostic trial for Pancreatitis focused on measuring MRI
Eligibility Criteria
Aim 1- Patient Group: Inclusion Criteria: Age 5 to <21 years Scheduled for clinically-indicated gastrointestinal endoscopy Clinical diagnosis or suspicion of exocrine pancreatic insufficiency Exclusion Criteria: 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 Control Group: Inclusion Criteria: Age 5 to <21 years Scheduled for clinically-indicated gastrointestinal endoscopy Exclusion Criteria: Sweat chloride >60 mmol/L Clinical diagnosis of gastrointestinal pathology Clinical diagnosis or history of pancreatic disease 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 Aim 2- Acute Pancreatitis Group: Inclusion Criteria: Age 5 to <21 years Clinically documented episode of acute pancreatitis Exclusion Criteria: More than one episode of acute pancreatitis 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) Pregnancy Acute Recurrent Pancreatitis Group: Inclusion Criteria: Age 5 to <21 years Clinical diagnosis of acute recurrent pancreatitis Exclusion Criteria: 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) Pregnancy Pancreatitis-Related Diabetes Group: Inclusion Criteria: Age 5 to <21 years Clinical diagnosis of pancreatitis-related diabetes Exclusion Criteria: 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) Pregnancy Aim 3- Control Group: Inclusion Criteria: • Age 5 to <21 years Exclusion Criteria: Sweat chloride >60 mmol/L Clinical diagnosis of gastrointestinal pathology Clinical diagnosis or history of pancreatic disease, including acute pancreatitis Need for sedation for MRI Contraindication to MRI (implanted metal hardware) Allergy to secretin Pregnancy Acute Pancreatitis Group: Inclusion Criteria: Age 5 to <21 years Clinically documented episode of acute pancreatitis Exclusion Criteria: More than one episode of acute pancreatitis 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 Acute Recurrent Pancreatitis Group: Inclusion Criteria: Age 5 to <21 years Clinical diagnosis of acute recurrent pancreatitis with no evidence of CP or EPI Exclusion Criteria: 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 Chronic Pancreatitis Group: Inclusion Criteria: Age 5 to <21 years Clinical diagnosis of chronic pancreatitis Exclusion Criteria: 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 Aim 4- Inclusion Criteria: Age 5 to <21 years Completed research MRI under Aims 1 or 3 of this study Exclusion Criteria: Failed/unable 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 Need for sedation for MRI Contraindication to MRI (implanted metal hardware) Allergy to secretin Pregnancy Aim 5- Inclusion Criteria: • MRI performed at CCHMC Exclusion Criteria: Severe image artifact compromising image quality (judgement of study team) Age >21 years
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
No Intervention
Imaging markers of exocrine and endocrine insufficiency
Imaging markers of diabetes and prediction of progression to diabetes
Imaging stratification of stages of pancreatitis
Imaging reproducibility
Automated or semi-automated image analysis
We will prospectively enroll 85 participants; 40 with known or suspected EPI and 45 controls (no known organic gastrointestinal pathology and no history of pancreatic disease) in this aim. Participants will be undergoing clinically-indicated endoscopy and will have endoscopic pancreatic function tests (ePFTs) collected for research during the clinically-indicated endoscopy examination. A research blood draw and a research stool collection will also be collected from all participants. Participants will undergo a research MRI examination with administration of intravenous secretin within 2 weeks of their clinical endoscopy but no sooner than 2 hours before or after endoscopy.
We will prospectively enroll 30 participants; 10 with a single episode of acute pancreatitis, 10 with acute recurrent pancreatitis, and 10 with pancreatitis-related diabetes in this aim. Participants will undergo a research MRI examination. Participants will also undergo a research blood draw for laboratory analysis and 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.
We will prospectively enroll 60 participants; 15 healthy controls, 15 participants with a single episode of acute pancreatitis, 15 participants with acute recurrent pancreatitis, and 15 participants with chronic pancreatitis. A research blood draw and a research stool collection will be collected from all participants. Participants will undergo a research MRI examination with administration of intravenous secretin.
We will prospectively enroll up to 20 participants enrolled in Aims 1 or 3 (up to 5 controls and 15 patients with pancreatic disease) to undergo repeat research MRI imaging between 24 hours and 14 days after their first research MRI. Participants will undergo a research MRI examination with administration of intravenous secretin, identical to the research MRI performed under Aims 1 or 3. MRI images will be quantitatively analyzed and agreement between the two MRI examinations (1st and repeat MRI) will be assessed.
We will use images prospectively collected under Aims 1-3, as well as existing images that had been obtained for clinical care of children with pancreatitis at CCHMC to develop and optimize image processing pipelines for MRI images. Performance of these pipelines will be benchmarked against manual segmentation performed by multiple observers.