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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreTrial 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
Blood Tests
2015
Completed Phase 2
~30
Genetic Sequencing
2015
N/A
~120
Secretin
2020
Completed Phase 4
~280
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,401 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,046 Total Patients Enrolled
107 Trials studying Diabetes
138,663 Patients Enrolled for Diabetes
Andrew Trout, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
2 Previous Clinical Trials
158 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of cancer.I need medication to help me stay calm during an MRI.I haven't had cancer in the last 5 years, except for skin cancer.I have had acute pancreatitis after my first research MRI.I am older than 21 years.I have been diagnosed with or have a history of pancreatic disease.I have diabetes caused by pancreatitis.I have a disorder that affects my lymph cells.I have had a condition where my lymphocytes grow abnormally.I am between 5 and 20 years old.I have had more than one episode of acute pancreatitis.I am scheduled for a GI endoscopy as recommended by my doctor.I have been diagnosed with a gastrointestinal condition.I have had a documented episode of acute pancreatitis.I might have a condition where my pancreas doesn't make enough enzymes.I have had GI surgery or pancreas treatment since my first research MRI.I have been diagnosed with recurring pancreatitis.I have had acute pancreatitis within the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Imaging reproducibility
- Group 2: Imaging markers of exocrine and endocrine insufficiency
- Group 3: Automated or semi-automated image analysis
- Group 4: Imaging markers of diabetes and prediction of progression to diabetes
- Group 5: Imaging stratification of stages of pancreatitis
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What qualities make someone an ideal candidate for this trial?
"To join this medical study, individuals with pancreatitis aged between 5 and 21 years old should apply. The trial is hoping to enrol a total of 195 participants."
Answered by AI
To what extent can imaging markers of exocrine and endocrine insufficiency be detrimental to individuals?
"Having reached the final stage of clinical trials, Imaging markers of exocrine and endocrine insufficiency have been deemed safe enough to receive a score of 3 on our team's safety scale."
Answered by AI
Is there still space available for participants in this trial?
"The records available on clinicaltrials.gov suggest that this investigation, which was first advertised on December 1st 2022 and last updated 12th of the same month, is not presently seeking new participants. Nonetheless, 1280 other trials are currently open for enrolment."
Answered by AI
Does this healthcare experiment accept participants who are over 35 years of age?
"To partake in this experiment, potential participants must be aged from 5 to 21. As of now, the scientific community has identified 195 trials for those under 18 and 974 for persons over 65 years old."
Answered by AI
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