Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
PHASE4
195 participants
INTERVENTIONAL
2023-01-18
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers
NCT01452217
Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas
NCT04275557
Secretin-enhanced Magnetic Resonance Imaging (S-MRI) for Pancreatic Cancer Detection
NCT01094626
Comparison of Secretin-enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) to Endoscopic Pancreatic Function Test (ePFT) in Diagnosing Pancreatic Exocrine Insufficiency
NCT01094600
Follow-up Study of Complications of Acute Pancreatitis
NCT02305914
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigator's data has shown that CFTR gene variants play a significant role in progression to diabetes post first attack AP. Existing literature suggests that imaging findings such as decreased pancreas volume are associated with diabetes, but this has not been systematically studied in children.
EPI, defined as insufficient secretion of digestive enzymes and fluid by the pancreas, can have significant effects in childhood including malnutrition, osteoporosis, and growth failure. If diagnosed early, EPI can be treated with pancreatic enzyme replacement, improving nutrition and stabilizing growth. Unfortunately, diagnosing EPI early and accurately is a challenge in children and it is currently not possible to predict progression to CP or development of EPI.
Magnetic resonance imaging (MRI) is a powerful, non-invasive technique, capable of characterizing pancreatic disease. Quantitative non-contrast MRI techniques are attractive as potential markers of pancreatic disease but they have not been validated for diagnosis or prediction of diabetes or EPI in children and they have not been explored for staging of pediatric pancreatitis.
The overall goals of this study are to:
1. Define associations between non-invasive, quantitative MRI measures and established measures of pancreas health and function including diabetes and EPI in children
2. Identify clinical, genetic and imaging-related factors that predict progression to diabetes in children with pancreatitis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Imaging markers of exocrine and endocrine insufficiency
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.
Research MRI with administration of intravenous secretin
Participants will undergo a research MRI examination with intravenous administration of secretin. MRI images will be quantitatively analyzed and will be compared to / used to predict exocrine and endocrine pancreatic insufficiency based on the reference standards of ePFTs or fecal elastase and blood hemoglobin A1c (HbA1c) and fasting glucose, respectively.
Blood Tests
Research blood draw (for markers of pancreatic endocrine insufficiency)
Stool Tests
Research stool collection (for fecal elastase as a marker of exocrine insufficiency)
Survey Completion
Participants will be contacted to complete a survey and their charts will be reviewed annually after research MRI to identify any evidence of subsequent development of pancreatic endocrine insufficiency or progression of pancreatitis. Survey and chart review will occur within +/- 14 days of the anniversary date.
Endoscopic pancreatic function tests (ePFTs)
At least two duodenal fluid aspirates will be collected over 15 minutes following secretin administration. Aspirates will be immediately pH tested and will be submitted for analysis of bicarbonate, enzyme (trypsin, amylase, lipase, chymotrypsin) activity, and total protein.
Secretin
Participants enrolled in Aim 1, Aim 3, and Aim 4 will receive intravenous secretin at a dose of 0.2 mcg/kg (maximum 16 mcg).
Participants in Aim 1 will receive two doses (1 during endoscopy and 1 during MRI). Participants in Aim 3 will receive one dose during MRI.
Participants in Aim 4 will receive two doses (1 during each MRI).
Secretin for intravenous use is FDA-approved for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction. Safety and effectiveness of secretin in pediatrics have not been established. However, secretin is routinely used in children at CCHMC at the same dose at which it will be administered for this study.
Imaging markers of diabetes and prediction of progression to diabetes
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.
Research MRI without administration of intravenous secretin
Participants will undergo a research MRI examination. MRI images will be quantitatively analyzed and will be compared to / used to predict diabetes.
Genetic Sequencing
Blood will be drawn 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.
Blood Tests
Research blood draw (for markers of pancreatic endocrine insufficiency)
Survey Completion
Participants will be contacted to complete a survey and their charts will be reviewed annually after research MRI to identify any evidence of subsequent development of pancreatic endocrine insufficiency or progression of pancreatitis. Survey and chart review will occur within +/- 14 days of the anniversary date.
Imaging stratification of stages of pancreatitis
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.
Research MRI with administration of intravenous secretin
Participants will undergo a research MRI examination with intravenous administration of secretin. MRI images will be quantitatively analyzed and will be compared to / used to predict exocrine and endocrine pancreatic insufficiency based on the reference standards of ePFTs or fecal elastase and blood hemoglobin A1c (HbA1c) and fasting glucose, respectively.
Blood Tests
Research blood draw (for markers of pancreatic endocrine insufficiency)
Stool Tests
Research stool collection (for fecal elastase as a marker of exocrine insufficiency)
Survey Completion
Participants will be contacted to complete a survey and their charts will be reviewed annually after research MRI to identify any evidence of subsequent development of pancreatic endocrine insufficiency or progression of pancreatitis. Survey and chart review will occur within +/- 14 days of the anniversary date.
Secretin
Participants enrolled in Aim 1, Aim 3, and Aim 4 will receive intravenous secretin at a dose of 0.2 mcg/kg (maximum 16 mcg).
Participants in Aim 1 will receive two doses (1 during endoscopy and 1 during MRI). Participants in Aim 3 will receive one dose during MRI.
Participants in Aim 4 will receive two doses (1 during each MRI).
Secretin for intravenous use is FDA-approved for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction. Safety and effectiveness of secretin in pediatrics have not been established. However, secretin is routinely used in children at CCHMC at the same dose at which it will be administered for this study.
Imaging reproducibility
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.
Research MRI with administration of intravenous secretin
Participants will undergo a research MRI examination with intravenous administration of secretin. MRI images will be quantitatively analyzed and will be compared to / used to predict exocrine and endocrine pancreatic insufficiency based on the reference standards of ePFTs or fecal elastase and blood hemoglobin A1c (HbA1c) and fasting glucose, respectively.
Secretin
Participants enrolled in Aim 1, Aim 3, and Aim 4 will receive intravenous secretin at a dose of 0.2 mcg/kg (maximum 16 mcg).
Participants in Aim 1 will receive two doses (1 during endoscopy and 1 during MRI). Participants in Aim 3 will receive one dose during MRI.
Participants in Aim 4 will receive two doses (1 during each MRI).
Secretin for intravenous use is FDA-approved for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction. Safety and effectiveness of secretin in pediatrics have not been established. However, secretin is routinely used in children at CCHMC at the same dose at which it will be administered for this study.
Automated or semi-automated image analysis
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Research MRI without administration of intravenous secretin
Participants will undergo a research MRI examination. MRI images will be quantitatively analyzed and will be compared to / used to predict diabetes.
Research MRI with administration of intravenous secretin
Participants will undergo a research MRI examination with intravenous administration of secretin. MRI images will be quantitatively analyzed and will be compared to / used to predict exocrine and endocrine pancreatic insufficiency based on the reference standards of ePFTs or fecal elastase and blood hemoglobin A1c (HbA1c) and fasting glucose, respectively.
Genetic Sequencing
Blood will be drawn 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.
Blood Tests
Research blood draw (for markers of pancreatic endocrine insufficiency)
Stool Tests
Research stool collection (for fecal elastase as a marker of exocrine insufficiency)
Survey Completion
Participants will be contacted to complete a survey and their charts will be reviewed annually after research MRI to identify any evidence of subsequent development of pancreatic endocrine insufficiency or progression of pancreatitis. Survey and chart review will occur within +/- 14 days of the anniversary date.
Endoscopic pancreatic function tests (ePFTs)
At least two duodenal fluid aspirates will be collected over 15 minutes following secretin administration. Aspirates will be immediately pH tested and will be submitted for analysis of bicarbonate, enzyme (trypsin, amylase, lipase, chymotrypsin) activity, and total protein.
Secretin
Participants enrolled in Aim 1, Aim 3, and Aim 4 will receive intravenous secretin at a dose of 0.2 mcg/kg (maximum 16 mcg).
Participants in Aim 1 will receive two doses (1 during endoscopy and 1 during MRI). Participants in Aim 3 will receive one dose during MRI.
Participants in Aim 4 will receive two doses (1 during each MRI).
Secretin for intravenous use is FDA-approved for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction. Safety and effectiveness of secretin in pediatrics have not been established. However, secretin is routinely used in children at CCHMC at the same dose at which it will be administered for this study.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Scheduled for clinically-indicated gastrointestinal endoscopy
* Clinical diagnosis or suspicion of exocrine pancreatic insufficiency
* Age 5 to \<21 years
* Scheduled for clinically-indicated gastrointestinal endoscopy
* Age 5 to \<21 years
* Clinically documented episode of acute pancreatitis
* Age 5 to \<21 years
* Clinical diagnosis of acute recurrent pancreatitis
* Age 5 to \<21 years
* Clinical diagnosis of pancreatitis-related diabetes
• Age 5 to \<21 years
* Age 5 to \<21 years
* Clinically documented episode of acute pancreatitis
* Age 5 to \<21 years
* Clinical diagnosis of acute recurrent pancreatitis with no evidence of CP or EPI
* Age 5 to \<21 years
* Clinical diagnosis of chronic pancreatitis
* Age 5 to \<21 years
* Completed research MRI under Aims 1 or 3 of this study
• MRI performed at CCHMC
Exclusion Criteria
* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI
* Need for sedation for MRI
* Contraindication to MRI (implanted metal hardware)
* Allergy to secretin
* Pregnancy
Control Group:
* Sweat chloride \>60 mmol/L
* Clinical diagnosis of gastrointestinal pathology
* Clinical diagnosis or history of pancreatic disease
* 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
* Contraindication to MRI (implanted metal hardware)
* Allergy to secretin
* Pregnancy
Aim 2-
Acute Pancreatitis Group:
* More than one episode of acute pancreatitis
* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI
* Need for sedation for MRI
* Contraindication to MRI (implanted metal hardware)
* Pregnancy
Acute Recurrent Pancreatitis Group:
* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI
* Need for sedation for MRI
* Contraindication to MRI (implanted metal hardware)
* Pregnancy
Pancreatitis-Related Diabetes Group:
* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI
* Need for sedation for MRI
* Contraindication to MRI (implanted metal hardware)
* Pregnancy
Aim 3-
Control Group:
* Sweat chloride \>60 mmol/L
* Clinical diagnosis of gastrointestinal pathology
* Clinical diagnosis or history of pancreatic disease, including acute pancreatitis
* Need for sedation for MRI
* Contraindication to MRI (implanted metal hardware)
* Allergy to secretin
* Pregnancy
Acute Pancreatitis Group:
* More than one episode of acute pancreatitis
* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI
* Need for sedation for MRI
* Contraindication to MRI (implanted metal hardware)
* Allergy to secretin
* Pregnancy
Acute Recurrent Pancreatitis Group:
* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI
* Need for sedation for MRI
* Contraindication to MRI (implanted metal hardware)
* Allergy to secretin
* Pregnancy
Chronic Pancreatitis Group:
* Current acute pancreatitis or acute pancreatitis less than 30 days prior to research MRI
* Need for sedation for MRI
* Contraindication to MRI (implanted metal hardware)
* Allergy to secretin
* Pregnancy
Aim 4-
* Failed/unable to complete first research MRI under Aims 1 or 3
* Episode of acute pancreatitis since first research MRI
* Current acute pancreatitis
* Any gastrointestinal surgery or pancreas intervention (e.g. ERCP) since first research MRI
* Need for sedation for MRI
* Contraindication to MRI (implanted metal hardware)
* Allergy to secretin
* Pregnancy
Aim 5-
* Severe image artifact compromising image quality (judgement of study team)
* Age \>21 years
5 Years
21 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew Trout, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-0779
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.