Imaging Biomarkers of Pancreatic Function and Disease

• Status: Enrolling by invitation
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Secretin

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