By InvitationPhase 4

Imaging Biomarkers of Pancreatic Function and Disease

United States195 participantsStarted 2023-01-18

Plain-language 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.

Who can participate

Age range5 Years – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * …

What they're measuring

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

Timeframe: 5 years

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

Timeframe: 5 years

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

Timeframe: 5 years

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

Timeframe: 5 years

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

Timeframe: 5 years

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

Timeframe: 5 years

Frequency of genetic mutations in patients progressing to diabetes vs. those not

Timeframe: 5 years

Trial details

NCT IDNCT05659147

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Pancreatitis trials

Plain-language summary

Who can participate

Age range5 Years – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 5 years

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

Timeframe: 5 years

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

Timeframe: 5 years

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

Timeframe: 5 years

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

Timeframe: 5 years

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

Timeframe: 5 years

Frequency of genetic mutations in patients progressing to diabetes vs. those not

Timeframe: 5 years