Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00621283
Recruitment Status : Terminated (Poor patient enrollment due to logistical issues)
First Posted : February 22, 2008
Last Update Posted : January 29, 2009
Information provided by:
Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Recurrent Pancreatitis Chronic Pancreatitis Drug: RG1068 (Synthetic Human Secretin) Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: RG1068 (Synthetic Human Secretin) Enhanced MRCP for Morphological Evaluation of the Pancreatic Duct in the Pediatric Population
Study Start Date : February 2008
Estimated Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: 1
Drug + MR with MRCP
Drug: RG1068 (Synthetic Human Secretin)
Dose: 0.2 μg/kg of synthetic human or 18.5 µg for patients over 50 kg Route: Intravenous Frequency: Once Duration: Over 1 minute

Primary Outcome Measures :
  1. 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. [ Time Frame: 1 ]

Secondary Outcome Measures :
  1. Laboratory [ Time Frame: 2 ]

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00621283

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Dushyant V Sahani Massachusetts General Hospital

Responsible Party: Dr. Dushyant Sahani, Massachusetts General Hospital Identifier: NCT00621283     History of Changes
Other Study ID Numbers: 2006P002499
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs