Diagnostic Imaging for Pancreatitis

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Acute pancreatitis, Pregnancy, Sedation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

195 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is MRI with secretin safe for humans?

MRI with secretin is generally considered safe for humans, as it is a non-invasive imaging technique used to improve the visibility of the pancreatic ducts and assess pancreatic function. The studies reviewed did not report any significant safety concerns related to the use of secretin in MRI procedures. ^{1 2 3 4 5}

How is the treatment using MRI with secretin different from other treatments for pancreatitis?

This treatment is unique because it uses MRI (a type of imaging) with and without secretin (a hormone that stimulates the pancreas) to non-invasively assess pancreatic function and detect abnormalities, unlike traditional methods that may require more invasive procedures. ^{1 3 5 6 7}

What data supports the effectiveness of this treatment for pancreatitis?

Research shows that using secretin (a hormone that stimulates the pancreas) with MRI helps improve the visibility of the pancreatic ducts and assess pancreatic function, which is useful in diagnosing and managing chronic pancreatitis. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrew Trout, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have diabetes caused by pancreatitis.

I am between 5 and 20 years old.

MRI performed at CCHMC

Exclusion Criteria

I have a history of cancer.

Patient living outside the US

Failed/unable to complete first research MRI under Aims 1 or 3

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Testing

Participants undergo research MRI examinations, blood tests, stool tests, and endoscopic pancreatic function testing

2 weeks

Multiple visits for MRI and testing

Follow-up

Participants are monitored for safety and effectiveness after imaging and testing

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Research MRI with administration of intravenous secretin
• Research MRI without administration of intravenous secretin
• Survey Completion

Trial Overview 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.

How Is the Trial Designed?

Group I: Imaging stratification of stages of pancreatitis Experimental Treatment 5 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 reproducibility Experimental Treatment 2 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 insufficiency Experimental Treatment 6 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 diabetes Experimental Treatment 4 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 analysis Active Control 1 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.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Assessment of chronic pancreatitis: utility of diffusion-weighted MR imaging with secretin enhancement. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Idiopathic chronic pancreatitis in children: MR cholangiopancreatography after secretin administration. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Diffusion-weighted MR imaging in the evaluation of pancreatic exocrine function before and after secretin stimulation. [2015]

4. Italy pubmed.ncbi.nlm.nih.gov

[Dynamic pancreatography with magnetic resonance after functional stimulus with secretin in chronic pancreatitis]. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

MR imaging of the pancreas: a pictorial tour. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Prospective Assessment of Normal Pancreatic Secretory Function Measured by MRI in a Cohort of Healthy Children. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Exocrine pancreatic function: evaluation with MR imaging before and after secretin stimulation. [2015]