Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population

Stopped early · Phase 1

Conditions studied: Acute Recurrent Pancreatitis, Chronic Pancreatitis

In brief

1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the diameter of the pancreatic duct when used during Magnetic Resonance Pancreatography. 2. To demonstrate that RG1068-enhanced MRCP improves image quality relative to unenhanced MRCP in patients with unexplained acute recurrent pancreatitis (ARP) and chronic pancreatitis. 3. To evaluate if the use of RG1068-enhanced MRCP improves structural delineation of the pancreatic duct as compared to the non-enhanced MRCP. 4. To assess pancreatic exocrine function by quantifying pancreatic fluid output into the duodenum and the apparent diffusion coefficient of the pancreas.

Key facts

Study ID

NCT00621283

Run by

Massachusetts General Hospital

People needed

0

Starts

2008-02-01

Expected to finish

2008-12-01

Last updated by the study team

2009-01-29

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females 2-18 years of age
• Is clinically indicated for MRCP of the pancreas based on clinical criteria
• Scheduled for MRCP and therapeutic or diagnostic ERCP or surgery for the assessment of chronic pancreatitis or acute recurrent pancreatitis (Children with a single episode of pancreatitis will not be included)
• Parent or legal guardian has been fully informed and has personally signed and dated the Written Informed Consent and Health Insurance Portability Accountability Act (HIPAA) provisions
• Is a male, or is a female not of childbearing potential, or is a female of childbearing potential who is using effective contraception and has a negative serum pregnancy test on the same day, but prior to, study drug administration
• Is able and willing to complete all study procedures specified in the protocol

You may not qualify if…

• Presence of a pancreatic stent
• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease which, in the opinion of the investigator, precludes study participation
• History of sensitivity to any of the ingredients in the study drug
• Pregnancy
• Any contraindication to MRI procedure, including but not limited to implanted metal devices (e.g., pacemaker, aneurysm clips, cochlear implants)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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