Imaging Biomarkers of Pancreatic Function and Disease

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Dec 12, 2022

Keywords

ClinConnect Summary

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.

The investigator's data has shown that CFTR g...

Gender

ALL

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