Healthy Volunteers
Conditions
Brief summary
The goal of this research study is to learn more about the pancreas. The investigators want to use Magnetic Resonance Cholangiopancreatography (MRCP) to learn more about the size of a normal pancreas. MRCP is a special kind of MRI exam that produces detailed images of the pancreas. The investigators also want to figure out how much fluid the pancreas releases in response to secretin. Secretin is a chemical in the body that causes the pancreas to release fluid that helps with digestion. Secretin is used during the MRCP (MR-PFT) to help identify dysfunction of the pancreas. MR elastography (MRE) will be used to measure how hard the pancreas is. MRE is a special kind of MRI that uses vibrations to image tissue.
Detailed description
Introduction/Methods: Pancreatic fibrosis is the end stage of chronic pancreatitis (CP), which leads to loss of acinar volume and secretory capacity, and ultimately pancreatic insufficiency (PI). CP and congenital PI affect the pediatric population, and are both increasingly recognized in children. PI has serious negative implications on a child's growth and health but, if diagnosed early, PI can be treated, minimizing the detrimental effects of PI. Currently, direct pancreatic function testing (PFT) via collection of pancreatic fluid is the gold standard for diagnosis of PI but it is an invasive testing that may require sedation or general anesthesia. Magnetic resonance cholangiopancreatography (MRCP) with secretin administration (MR-PFT) and MR elastography (MRE) may allow non-invasive, and potentially early diagnosis of CP and PI. Currently, however, normative data with which to compare MR-PFT and MRE results in pediatric patients with suspected CP/PI is not available. Aims: The investigators propose to determine the normal range for secreted pancreatic fluid volume in response to secretin administration and determine the normal range for pancreatic parenchymal stiffness in a pediatric population that is not affected by pancreatic disease. To date, the investigators have validated their MRCP technique and have successfully performed both MR-PFT and MRE in CP patients; however normative data is essential for validation of our non-invasive technique.
Interventions
DRUGSecretin
Sponsors
ChiRhoClin, Inc.
The National Pancreas Foundation
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects between the ages of 6 and 15.9 years. 2. Subjects without a documented history of (or suggestive of) pancreatic disease
Exclusion criteria
1. History of pancreatic disease, liver disease, intra-abdominal neoplasm, abdominal inflammatory process such as inflammatory bowel disease (IBD), or systemic illness that may affect pancreatic state (e.g. cystic fibrosis). 2. Subjects with surgical hardware/implanted devices making them ineligible for MRI (e.g. pacemaker or other implanted medical device not approved for MRI). 3. Subjects who require any form of sedation or general anesthesia for MRI. 4. Subjects unable to breath-hold for the required 15-20 second imaging sequence. 5. Subjects who are pregnant or less than 12 months post-partum.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Secreted Fluid Volume as Measured by MR-PFT | 35 minutes (20 min pre-secretin, 15 minutes post-secretin) | Participants underwent MR imaging prior to and following secretin administration. Pre-secretin imaging lasts approximately 20 minutes. Post-secretin images were acquired at 1 minute, 5 minutes and 15 minutes following completion of secretin injection. Pre-secretin enteric fluid volumes were subtracted from post-secretin enteric fluid volumes for each participant to determine volume secreted in response to secretin administration at each time point. A commercially available software package determines the area of fluid signal on the MR images. The fluid signal from the pre-secretin images is then subtracted from the each post-secretin image (1, 5 and 15 minutes images) to determine the amount of fluid produced by the introduction of secretin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE) | Single time point, pre-secretin | Healthy controls underwent 3D MRE on a 1.5T scanner. Regions of interest for measurement of pancreatic stiffness were drawn by two blinded readers and statistical analysis were performed for comparisons between the 2 groups. |
| Volumetric Measurement of Pancreatic Parenchymal Volume | Single time point, pre-secretin | Pancreatic parenchymal volume by manual segmentation (tracing) of pancreas contours on magnetic resonance imaging (MRI) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Participants Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation.
Secretin | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | participant aversion to IV | 5 |
| Overall Study | participant fear of MRI scanner | 2 |
Baseline characteristics
| Characteristic | Healthy Participants |
|---|---|
| Age, Customized 12-16 years | 23 Participants |
| Age, Customized 6-11 years | 27 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Total Secreted Fluid Volume as Measured by MR-PFT
Participants underwent MR imaging prior to and following secretin administration. Pre-secretin imaging lasts approximately 20 minutes. Post-secretin images were acquired at 1 minute, 5 minutes and 15 minutes following completion of secretin injection. Pre-secretin enteric fluid volumes were subtracted from post-secretin enteric fluid volumes for each participant to determine volume secreted in response to secretin administration at each time point. A commercially available software package determines the area of fluid signal on the MR images. The fluid signal from the pre-secretin images is then subtracted from the each post-secretin image (1, 5 and 15 minutes images) to determine the amount of fluid produced by the introduction of secretin.
Time frame: 35 minutes (20 min pre-secretin, 15 minutes post-secretin)
Population: Healthy participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Participants | Total Secreted Fluid Volume as Measured by MR-PFT | 79 mL |
Secondary
Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE)
Healthy controls underwent 3D MRE on a 1.5T scanner. Regions of interest for measurement of pancreatic stiffness were drawn by two blinded readers and statistical analysis were performed for comparisons between the 2 groups.
Time frame: Single time point, pre-secretin
Population: Of the 50 healthy controls recruited, complete MRE data were available for 49 subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Participants | Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE) | 1.7 kPa | Standard Deviation 0.3 |
Secondary
Volumetric Measurement of Pancreatic Parenchymal Volume
Pancreatic parenchymal volume by manual segmentation (tracing) of pancreas contours on magnetic resonance imaging (MRI)
Time frame: Single time point, pre-secretin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Participants | Volumetric Measurement of Pancreatic Parenchymal Volume | 46 mL | Standard Deviation 18.8 |