Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population

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Brief Title

Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population

Official Title

RG1068 (Synthetic Human Secretin) Enhanced MRCP for Morphological Evaluation of the Pancreatic Duct in the Pediatric Population

Brief Summary

      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.
    

Detailed Description

      Until relatively recently, endoscopic retrograde cholangiopancreatography (ERCP) was the
      primary diagnostic and therapeutic modality for assessing patients with suspected pancreatic
      disease or abnormalities. However, this invasive procedure carries with it a significant
      potential for complications including acute pancreatitis, hemorrhage and infection, as well
      as reactions to contrast material or premedications and exposure to radiation. In addition,
      the success of such procedures, both from the standpoint of safety and efficacy, is highly
      dependent on the skill of the endoscopist, and the cost of ERCP is relatively high.

      The advent of magnetic resonance imaging has resulted in the development of a less expensive,
      non-invasive, radiation-free means of assessing the pancreaticobiliary system: Magnetic
      Resonance Cholangiopancreatography (MRCP). MRCP uses stationary water in biliary and
      pancreatic secretions as an intrinsic contrast medium, thus facilitating examination of
      pancreatic and biliary ducts and surrounding tissue. Secretin, which promotes the secretion
      of pancreatic fluid into the pancreatic ducts, can thereby enhance the MR imaging signal,
      improving delineation of both normal and abnormal structures, as well as highlighting
      abnormal fluid collections and leakage. Conversely, filling defects can indicate the presence
      of stones or mass lesions.

      This study is being undertaken to prospectively assess the effectiveness of RG1068-enhanced
      MRCP relative to unenhanced MRCP in pediatric patients. RG1068 is a synthetic human secretin
      with a pharmacological profile very similar to that of biological and synthetic porcine
      secretins. Secretin is a 27-amino acid gastrointestinal peptide hormone that is produced by
      S-cells in the duodenum in response to the pH decrease caused by the passage of partially
      digested food from the stomach into the intestine. RG1068 is identical in amino acid sequence
      to naturally occurring human secretin and differs from porcine secretin in 2 amino acids.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

MR and MRCP - Images will be evaluated for quality, main and branch duct visualization, ductal diameter and improved visualization of structural abnormalities with and without use of RG1068. Pancreatic exocrine function will be assessed.

Secondary Outcome

 Laboratory

Condition

Acute Recurrent Pancreatitis

Intervention

RG1068 (Synthetic Human Secretin)

Study Arms / Comparison Groups

 1
Description:  Drug + MR with MRCP

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

February 2008

Completion Date

December 2008

Primary Completion Date

December 2008

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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)
      

Gender

All

Ages

2 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Dushyant V Sahani, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00621283

Organization ID

2006P002499



Study Sponsor

Massachusetts General Hospital


Study Sponsor

Dushyant V Sahani, Principal Investigator, Massachusetts General Hospital


Verification Date

January 2009