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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how well MRI scans predict complications from pancreatitis, a condition that inflames the pancreas. Participants will undergo MRI exams, some with secretin administered intravenously to enhance imaging, to compare these results with other tests like blood and stool samples. The goal is to determine if MRI can identify issues like diabetes or other complications related to pancreatitis. Individuals who have had a single episode of pancreatitis or experience recurring episodes might find this trial suitable. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

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.

What is the safety track record for the research MRI with administration of intravenous secretin?

Research has shown that using MRI with a small injection of secretin is generally safe. In past studies, only 0.5% of patients experienced mild side effects such as nausea, stomach pain, and skin redness. These effects are rare, and secretin quickly leaves the body.

While specific safety data for MRI without secretin is unavailable, MRI is a widely used and safe imaging tool in many medical settings. Overall, available research indicates that the treatment options in this study are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative MRI techniques to better understand and diagnose pancreatitis. Unlike traditional imaging methods, this trial uses MRI with intravenous secretin, a unique approach that may enhance the visualization of the pancreas and improve the accuracy of detecting different stages of the disease. Additionally, the trial aims to develop automated image analysis tools that could offer more precise and consistent results compared to manual assessments. These advancements could lead to earlier diagnosis and better treatment planning for patients with pancreatitis.

What evidence suggests that MRI is effective for diagnosing and predicting complications of pancreatitis?

Research has shown that using MRI with a special medicine called secretin greatly improves images of the pancreatic ducts. This technique, known as secretin-enhanced MRI (S-MRI), makes it easier to see the pancreas and nearby areas. In this trial, some participants will undergo a research MRI with intravenous secretin to assess its effectiveness in imaging. Studies have found that secretin helps produce clearer images, especially for ducts that are not naturally wide. This method is non-invasive, meaning it doesn't involve surgery, and it provides a better view of pancreatic function. While a regular MRI without secretin remains helpful and can identify problem areas, only a small number of cases require further examination. Overall, secretin-enhanced MRI is a valuable tool for diagnosing and understanding pancreatic issues. ^{1 2 6 7 8}

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

I need medication to help me stay calm during an MRI.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8068672/

Secretin-Enhanced MRCP: How and Why—AJR Expert ... Secretin-enhanced MRCP (S-MRCP) provides multiple advantages compared with standard MRCP for imaging the pancreaticobiliary tree.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02458118

Pancreatic Perfusion Using Secretin and MRI ... This study in 10 healthy volunteers demonstrated that at rest there was a higher blood flow within the body and the tail of the pancreas, compared to the head.

3. ajronline.org ajronline.org/doi/10.2214/AJR.10.5713

Secretin-Enhanced MRCP: Review of Technique and ... Secretin-enhanced MRCP is a noninvasive method of evaluating pancreatic function that involves stimulation of pancreatic exocrine function by IV secretin.

4. gastrojournal.org gastrojournal.org/article/S0016-5085%2814%2900724-0/fulltext

Administration of Secretin (RG1068) Increases the ... Administration of secretin improves noninvasive imaging of the pancreatic duct with magnetic resonance cholangiopancreatography (MRCP).

5. withpower.com withpower.com/trial/phase-4-pancreatitis-11-2022-65671

Diagnostic Imaging for Pancreatitis · Info for Participants 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 ...

6. ajronline.org ajronline.org/doi/10.2214/AJR.12.10271

Secretin-Stimulated MRCP in Volunteers: Assessment of ... The purpose of this study was to investigate the safety of secretin administration, improvement of duct visualization, and assessment of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4209541/

Magnetic resonance imaging of pancreatitis: An update - PMC This review addresses new trends in clinical pancreatic MR imaging emphasizing its role in imaging all types of acute and chronic pancreatitis, pancreatitis ...

8. ajronline.org ajronline.org/doi/10.2214/AJR.20.24857

Secretin-Enhanced MRCP: How and Why—AJR Expert Panel ... Secretin administration is safe; mild side effects, including nausea, abdominal pain, and flushing, occur in only 0.5% of patients [7]. Secretin is short acting ...