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NCT05659147

Imaging Biomarkers of Pancreatic Function and Disease

Enrolling by Invitation
PHASE4Ages 5–21InterventionalDiagnostic
Children's Hospital Medical Center, Cincinnati
~195 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:Research MRI without administration of intravenous secretinResearch MRI with administration of intravenous secretinGenetic SequencingBlood TestsStool TestsSurvey Completion

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
Measured over 5 years
+6 more outcomes measured

Conditions

Pancreatitis
Diabetes Mellitus

Explore related trials

Acute PancreatitisChronic PancreatitisGastrointestinal PolypPancreatic InsufficiencyPancreatitisPancreatitis-Related DiabetesRecurrent Acute Pancreatitis

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Andrew Trout, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age 5 to \<21 years
Scheduled for clinically-indicated gastrointestinal endoscopy
Clinical diagnosis or suspicion of exocrine pancreatic insufficiency
Age 5 to \<21 years
Scheduled for clinically-indicated gastrointestinal endoscopy
Age 5 to \<21 years
Clinically documented episode of acute pancreatitis
Age 5 to \<21 years
Clinical diagnosis of acute recurrent pancreatitis
Age 5 to \<21 years
Clinical diagnosis of pancreatitis-related diabetes
Age 5 to \<21 years
Clinically documented episode of acute pancreatitis
Age 5 to \<21 years
Clinical diagnosis of acute recurrent pancreatitis with no evidence of CP or EPI
Age 5 to \<21 years
Clinical diagnosis of chronic pancreatitis
Age 5 to \<21 years
Completed research MRI under Aims 1 or 3 of this study

Exclusion

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/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
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
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
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
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
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
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
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
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
Severe image artifact compromising image quality (judgement of study team)
Age \>21 years

What this trial measures

  • Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).5 years

    2 x 2 table analyses of pancreas volume (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)

  • Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).5 years

    2 x 2 table analyses of pancreas volume (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)

  • Pancreas T1 signal as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).5 years

    2 x 2 table analyses of pancreas T1 signal (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)

  • Pancreas T1 signal as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).5 years

    2 x 2 table analyses of pancreas T1 signal intensity (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)

  • Pancreas secreted fluid volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).5 years

    2 x 2 table analyses of pancreas secreted fluid volume (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)

  • Pancreas secreted fluid volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).5 years

    2 x 2 table analyses of pancreas secreted fluid volume (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)

  • Frequency of genetic mutations in patients progressing to diabetes vs. those not5 years

    Frequency of genetic mutations in each study group will be compared using 2x2 tables to identify mutations associated with development of diabetes