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Diagnostic Test

Diagnostic Imaging for Pancreatitis

Phase 4

Waitlist Available

Led By Andrew Trout, MD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial seeks to understand how MRI can be used to identify pancreatitis & predict long-term complications. It includes tests like endoscopy, blood tests, stool tests & MRI scans. Some participants will receive intravenous secretin.

Who is the study for?

This trial is for children and young adults aged 5 to under 21 with a clinical diagnosis or suspicion of pancreatic issues, such as insufficiency or pancreatitis-related diabetes. They must be scheduled for a GI endoscopy and have had an MRI at CCHMC. Pregnant individuals, those with acute pancreatitis, metal implants preventing MRI, secretin allergies, or who need sedation for MRI cannot participate.

What is being tested?

The study tests how well MRIs can identify pancreatitis and predict its chronic complications. It involves research MRIs (with some including secretin injection), genetic sequencing, blood/stool tests, surveys, and ePFTs during GI endoscopies. The goal is to compare these methods against standard tests and improve MRI analysis automation.

What are the potential side effects?

Potential side effects may include reactions to the intravenous secretin used in some MRIs like nausea or abdominal pain. Blood draws might cause minor discomfort or bruising. Endoscopic procedures carry risks like sore throat or very rarely more serious complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Imaging stratification of stages of pancreatitisExperimental Treatment5 Interventions

We 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.

Group II: Imaging reproducibilityExperimental Treatment2 Interventions

We will prospectively enroll up to 20 participants enrolled in Aims 1 or 3 (up to 5 controls and 15 patients with pancreatic disease) to undergo repeat research MRI imaging between 24 hours and 14 days after their first research MRI. Participants will undergo a research MRI examination with administration of intravenous secretin, identical to the research MRI performed under Aims 1 or 3. MRI images will be quantitatively analyzed and agreement between the two MRI examinations (1st and repeat MRI) will be assessed.

Group III: Imaging markers of exocrine and endocrine insufficiencyExperimental Treatment6 Interventions

We will prospectively enroll 85 participants; 40 with known or suspected EPI and 45 controls (no known organic gastrointestinal pathology and no history of pancreatic disease) in this aim. Participants will be undergoing clinically-indicated endoscopy and will have endoscopic pancreatic function tests (ePFTs) collected for research during the clinically-indicated endoscopy examination. A research blood draw and a research stool collection will also be collected from all participants. Participants will undergo a research MRI examination with administration of intravenous secretin within 2 weeks of their clinical endoscopy but no sooner than 2 hours before or after endoscopy.

Group IV: Imaging markers of diabetes and prediction of progression to diabetesExperimental Treatment4 Interventions

We will prospectively enroll 30 participants; 10 with a single episode of acute pancreatitis, 10 with acute recurrent pancreatitis, and 10 with pancreatitis-related diabetes in this aim. Participants will undergo a research MRI examination. Participants will also undergo a research blood draw for laboratory analysis and to enable gene sequencing for gene mutations associated with heritable pancreatitis. We will assess the association between identified gene variants and the presence of diabetes and will construct models based on identified variants to predict progression to diabetes.

Group V: Automated or semi-automated image analysisActive Control1 Intervention

We will use images prospectively collected under Aims 1-3, as well as existing images that had been obtained for clinical care of children with pancreatitis at CCHMC to develop and optimize image processing pipelines for MRI images. Performance of these pipelines will be benchmarked against manual segmentation performed by multiple observers.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Genetic Sequencing

2015

N/A

~120

Blood Tests

2015

Completed Phase 2

~30