Imaging Biomarkers of Pancreatic Function and Disease

What Was Tested

The trial (phase 4) is built around Secretin.

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.

It had five arms (groups): Imaging markers of exocrine and endocrine insufficiency (experimental), one (experimental), Imaging stratification of stages of pancreatitis (experimental), Imaging reproducibility (experimental) and Automated or semi-automated image analysis (no intervention).

The researchers 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.

The registry classes the interventions as diagnostic test, drug, genetic and other.

More on the Plan

Pancreatitis can be acute \[AP\], acute recurrent \[ARP\] (defined as two discrete attacks with interval resolution), or chronic \[CP\].

Currently, it is not possible to non-invasively diagnose or predict development of pancreatitis-related endocrine or exocrine insufficiency.

Magnetic resonance imaging (MRI) is a powerful, non-invasive technique, capable of characterizing pancreatic disease.

The overall goals of this study are to: 1.

Who Took Part

Enrollment: 195 planned participants were the target.

It was open to people of any sex aged from 5 years up to 21 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 5 to \<21 years. Scheduled for clinically-indicated gastrointestinal endoscopy. Clinical diagnosis or suspicion of exocrine pancreatic insufficiency.

The full record lists 3 inclusion and 77 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Secretin group and the comparison group ran side by side rather than switching.

Everyone knew when Secretin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-01-18 with completion listed for 2026-12.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency) (time frame: 5 years). Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency) (time frame: 5 years). Pancreas T1 signal as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency) (time frame: 5 years).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Secretin in 195 people.

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Secretin compound page, all human trials.