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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02869893 |
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Date of registration:
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05/06/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics
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Scientific title:
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Magnetic Resonance Cholangiopancreatography (MRCP): A Reliable, Non Invasive Method for Staging Chronic Pancreatitis From Minimal Change Disease to the Advanced Stages in Pediatrics |
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Date of first enrolment:
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August 10, 2016 |
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Target sample size:
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57 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02869893 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Maisam Abu-El-Haija, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Medical Center, Cincinnati |
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Name:
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Andrew Trout, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Medical Center, Cincinnati |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Drug: Secretin
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Primary Outcome(s)
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Total Secreted Fluid Volume as Measured by MR-PFT
[Time Frame: 35 minutes (20 min pre-secretin, 15 minutes post-secretin)]
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Secondary Outcome(s)
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Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE)
[Time Frame: Single time point, pre-secretin]
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Volumetric Measurement of Pancreatic Parenchymal Volume
[Time Frame: Single time point, pre-secretin]
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Secondary ID(s)
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CIN_MRCPStudy_001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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