PancreatitisPhase 4NCT05659147
Imaging Biomarkers of Pancreatic Function and Disease
A Phase 4 study testing Research MRI without administration of intravenous secretin, Research MRI with administration of intravenous secretin and Genetic Sequencing in people with Pancreatitis and Diabetes Mellitus, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis, Diabetes Mellitus
- What is being tested?
- Research MRI without administration of intravenous secretin, Research MRI with administration of intravenous secretin and Genetic Sequencing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 5 to <21 years
- 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
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 73Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
Read the detailed description
Pancreatitis can be acute [AP], acute recurrent [ARP] (defined as two discrete attacks with interval resolution), or chronic [CP]. Adult studies show that up to 40% of patients develop abnormal glucose metabolism after a single attack of AP, with a 2.5x increased risk of diabetes. CP is defined, in part, by the presence of established endocrine (diabetes) or exocrine pancreatic insufficiency [EPI]. Currently, it is not possible to non-invasively diagnose or predict development of pancreatitis-related endocrine or exocrine insufficiency.
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:
- Define associations between non-invasive, quantitative MRI measures and established measures of pancreas health and function including diabetes and EPI in children
- Identify clinical, genetic and imaging-related factors that predict progression to diabetes in children with pancreatitis.
- Conditions
- Pancreatitis, Diabetes Mellitus
- Being tested
- Research MRI without administration of intravenous secretin, Research MRI with administration of intravenous secretin, Genetic Sequencing, Blood Tests, Stool Tests
- Keywords
- MRI
- Medical subject headings
- Pancreatitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research MRI without administration of intravenous secretinDiagnostic test
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 secretinDiagnostic test
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 SequencingGenetic
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 TestsDiagnostic test
Research blood draw (for markers of pancreatic endocrine insufficiency)
Stool TestsDiagnostic test
Research stool collection (for fecal elastase as a marker of exocrine insufficiency)
Survey CompletionOther
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)Diagnostic test
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.
SecretinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Imaging markers of exocrine and endocrine insufficiency | Experimental | 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. Receives: Diagnostic Test: Research MRI with administration of intravenous secretin; Diagnostic Test: Blood Tests; Diagnostic Test: Stool Tests; Other: Survey Completion; Diagnostic Test: Endoscopic pancreatic function tests (ePFTs); Drug: Secretin |
| Imaging markers of diabetes and prediction of progression to diabetes | Experimental | 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. Receives: Diagnostic Test: Research MRI without administration of intravenous secretin; Genetic: Genetic Sequencing; Diagnostic Test: Blood Tests; Other: Survey Completion |
| Imaging stratification of stages of pancreatitis | Experimental | 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. Receives: Diagnostic Test: Research MRI with administration of intravenous secretin; Diagnostic Test: Blood Tests; Diagnostic Test: Stool Tests; Other: Survey Completion; Drug: Secretin |
| Imaging reproducibility | Experimental | 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. Receives: Diagnostic Test: Research MRI with administration of intravenous secretin; Drug: Secretin |
| Automated or semi-automated image analysis | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
2 x 2 table analyses of pancreas volume (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)
Measured: 5 years
Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
2 x 2 table analyses of pancreas volume (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)
Measured: 5 years
Pancreas T1 signal as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
2 x 2 table analyses of pancreas T1 signal (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)
Measured: 5 years
Pancreas T1 signal as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
2 x 2 table analyses of pancreas T1 signal intensity (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)
Measured: 5 years
Pancreas secreted fluid volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
2 x 2 table analyses of pancreas secreted fluid volume (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)
Measured: 5 years
Pancreas secreted fluid volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
2 x 2 table analyses of pancreas secreted fluid volume (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)
Measured: 5 years
Frequency of genetic mutations in patients progressing to diabetes vs. those not
Frequency of genetic mutations in each study group will be compared using 2x2 tables to identify mutations associated with development of diabetes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start18 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be prospectively recruited to one or more of four prospective imaging aims (Aims 1-4). All participants who enroll in any imaging Aim will have their images used for Aim 5 (image analysis aim) which will also include a retrospective component.
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Trout, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659147
- Sponsor's protocol ID
- 2022-0779
- Other IDs
- R01DK132346
- Status last verified
- Sep 2025
- First submitted
- 22 Nov 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Biomarkers of Pancreatic Function and Disease
- ClinicalTrials.gov ID
- NCT05659147
- Acronym / sponsor ID
- 2022-0779
- Conditions
- Pancreatitis, Diabetes Mellitus
- Keywords
- MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreatitis can be acute [AP], acute recurrent [ARP] (defined as two discrete attacks with interval resolution), or chronic [CP]. Adult studies show that up to 40% of patients develop abnormal glucose metabolism after a single attack of AP, with a 2.5x increased risk of diabetes. CP is defined, in part, by the presence of established endocrine (diabetes) or exocrine pancreatic insufficiency [EPI]. Currently, it is not possible to non-invasively diagnose or predict development of pancreatitis-related endocrine or exocrine insufficiency.
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:
- Define associations between non-invasive, quantitative MRI measures and established measures of pancreas health and function including diabetes and EPI in children
- Identify clinical, genetic and imaging-related factors that predict progression to diabetes in children with pancreatitis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Participants will be prospectively recruited to one or more of four prospective imaging aims (Aims 1-4). All participants who enroll in any imaging Aim will have their images used for Aim 5 (image analysis aim) which will also include a retrospective component.
| Arm | Type | Receives |
|---|---|---|
| Imaging markers of exocrine and endocrine insufficiency | Experimental | Diagnostic Test: Research MRI with administration of intravenous secretin, Diagnostic Test: Blood Tests, Diagnostic Test: Stool Tests, Other: Survey Completion, Diagnostic Test: Endoscopic pancreatic function tests (ePFTs), Drug: SecretinWe 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. |
| Imaging markers of diabetes and prediction of progression to diabetes | Experimental | Diagnostic Test: Research MRI without administration of intravenous secretin, Genetic: Genetic Sequencing, Diagnostic Test: Blood Tests, Other: Survey CompletionWe 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. |
| Imaging stratification of stages of pancreatitis | Experimental | Diagnostic Test: Research MRI with administration of intravenous secretin, Diagnostic Test: Blood Tests, Diagnostic Test: Stool Tests, Other: Survey Completion, Drug: SecretinWe 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. |
| Imaging reproducibility | Experimental | Diagnostic Test: Research MRI with administration of intravenous secretin, Drug: SecretinWe 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. |
| Automated or semi-automated image analysis | No 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 may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- Age 5 to <21 years
- 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
Key exclusion criteria (73 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research MRI without administration of intravenous secretinParticipants will undergo a research MRI examination. MRI images will be quantitatively analyzed and will be compared to / used to predict diabetes. | Diagnostic test | Imaging markers of diabetes and prediction of progression to diabetes |
| Research MRI with administration of intravenous secretinParticipants 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. | Diagnostic test | Imaging markers of exocrine and endocrine insufficiency, Imaging reproducibility, Imaging stratification of stages of pancreatitis |
| Genetic SequencingBlood 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. | Genetic | Imaging markers of diabetes and prediction of progression to diabetes |
| Blood TestsResearch blood draw (for markers of pancreatic endocrine insufficiency) | Diagnostic test | Imaging markers of diabetes and prediction of progression to diabetes, Imaging markers of exocrine and endocrine insufficiency, Imaging stratification of stages of pancreatitis |
| Stool TestsResearch stool collection (for fecal elastase as a marker of exocrine insufficiency) | Diagnostic test | Imaging markers of exocrine and endocrine insufficiency, Imaging stratification of stages of pancreatitis |
| Survey CompletionParticipants 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. | Other | Imaging markers of diabetes and prediction of progression to diabetes, Imaging markers of exocrine and endocrine insufficiency, Imaging stratification of stages of pancreatitis |
| 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. | Diagnostic test | Imaging markers of exocrine and endocrine insufficiency |
| SecretinParticipants 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. | Drug | Imaging markers of exocrine and endocrine insufficiency, Imaging reproducibility, Imaging stratification of stages of pancreatitis |
Primary outcome
Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
Time frame: 5 years
2 x 2 table analyses of pancreas volume (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)
Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
Time frame: 5 years
2 x 2 table analyses of pancreas volume (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)
Pancreas T1 signal as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
Time frame: 5 years
2 x 2 table analyses of pancreas T1 signal (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)
Pancreas T1 signal as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
Time frame: 5 years
2 x 2 table analyses of pancreas T1 signal intensity (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)
Pancreas secreted fluid volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
Time frame: 5 years
2 x 2 table analyses of pancreas secreted fluid volume (categorized as normal vs. abnormal) vs. exocrine function (categorized as normal vs. abnormal)
Pancreas secreted fluid volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency).
Time frame: 5 years
2 x 2 table analyses of pancreas secreted fluid volume (categorized as normal vs. abnormal) vs. endocrine function (categorized as normal vs. abnormal)
Frequency of genetic mutations in patients progressing to diabetes vs. those not
Time frame: 5 years
Frequency of genetic mutations in each study group will be compared using 2x2 tables to identify mutations associated with development of diabetes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Trout, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Research MRI without administration of intravenous secretin, Research MRI with administration of intravenous secretin and Genetic Sequencing in people with Pancreatitis and Diabetes Mellitus, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 73 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreas volume as a predictor of pancreas health and function (including endocrine and exocrine pancreatic insufficiency). (time frame: 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.