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MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT02869893
Collaborator
ChiRhoClin, Inc. (Industry), The National Pancreas Foundation (Other)
57
Enrollment
1
Location
1
Arm
7.9
Actual Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Magnetic Resonance Cholangiopancreatography (MRCP): A Reliable, Non Invasive Method for Staging Chronic Pancreatitis From Minimal Change Disease to the Advanced Stages in Pediatrics
Actual Study Start Date :
Aug 10, 2016
Actual Primary Completion Date :
Apr 6, 2017
Actual Study Completion Date :
Apr 6, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Healthy Participants

MRCP with Secretin and MR elastography will be performed on all participants.

Drug: Secretin
Other Names:
  • ChiRhoStim

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati
    • ChiRhoClin, Inc.
    • The National Pancreas Foundation

    Investigators

    • Principal Investigator: Maisam Abu-El-Haija, MD, Children's Hospital Medical Center, Cincinnati
    • Principal Investigator: Andrew Trout, MD, Children's Hospital Medical Center, Cincinnati

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT02869893
    Other Study ID Numbers:
    • CIN_MRCPStudy_001
    First Posted:
    Aug 17, 2016
    Last Update Posted:
    Aug 7, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Pancreatitis
    Pancreatitis, Chronic
    Secretin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Healthy Participants
    Arm/Group Description MRCP with Secretin and MR elastography will be performed on all participants. Secretin
    Period Title: Overall Study
    STARTED 57
    COMPLETED 50
    NOT COMPLETED 7

    Baseline Characteristics

    Arm/Group Title Healthy Participants
    Arm/Group Description Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation. Secretin
    Overall Participants 50
    Age, Customized (Count of Participants)
    6-11 years
    27
    54%
    12-16 years
    23
    46%
    Sex: Female, Male (Count of Participants)
    Female
    27
    54%
    Male
    23
    46%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    50
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    15
    30%
    White
    33
    66%
    More than one race
    1
    2%
    Unknown or Not Reported
    1
    2%

    Outcome Measures

    1. Primary Outcome
    Title Total Secreted Fluid Volume as Measured by MR-PFT
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Healthy participants
    Arm/Group Title Healthy Participants
    Arm/Group Description Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation. Secretin
    Measure Participants 50
    Median (Full Range) [mL]
    79
    2. Secondary Outcome
    Title Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Of the 50 healthy controls recruited, complete MRE data were available for 49 subjects
    Arm/Group Title Healthy Participants
    Arm/Group Description Healthy participants underwent MR elastography of the pancreas
    Measure Participants 49
    Mean (Standard Deviation) [kPa]
    1.7
    (0.3)
    3. Secondary Outcome
    Title Volumetric Measurement of Pancreatic Parenchymal Volume
    Description Pancreatic parenchymal volume by manual segmentation (tracing) of pancreas contours on magnetic resonance imaging (MRI)
    Time Frame Single time point, pre-secretin

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Healthy Participants
    Arm/Group Description Healthy participants will undergo Magnetic Resonance Imaging with secretin stimulation. Secretin
    Measure Participants 50
    Mean (Standard Deviation) [mL]
    46
    (18.8)

    Adverse Events

    Time Frame Approximately 2.5-3 hours
    Adverse Event Reporting Description Adverse events for this one visit study were collected from time of consent until completion of the study visit (approximately 2.5-3 hours)
    Arm/Group Title Healthy Participants
    Arm/Group Description MRCP with Secretin and MR elastography will be performed on all participants. Secretin
    All Cause Mortality
    Healthy Participants
    Affected / at Risk (%) # Events
    Total 0/50 (0%)
    Serious Adverse Events
    Healthy Participants
    Affected / at Risk (%) # Events
    Total 0/50 (0%)
    Other (Not Including Serious) Adverse Events
    Healthy Participants
    Affected / at Risk (%) # Events
    Total 1/50 (2%)
    Gastrointestinal disorders
    Nausea 1/50 (2%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Andrew Trout
    Organization Cincinnati Children's Hospital Medical Center
    Phone 513-803-3004
    Email andrew.trout@cchmc.org
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT02869893
    Other Study ID Numbers:
    • CIN_MRCPStudy_001
    First Posted:
    Aug 17, 2016
    Last Update Posted:
    Aug 7, 2020
    Last Verified:
    Jul 1, 2020