Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis

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Brief Title

Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis

Official Title

RG1068 (Synthetic Human Secretin) Enhanced Multidetector CT Pancreatography: Evaluation of the Pancreatic Duct in Patients With Known or Suspected Chronic Pancreatitis

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 Multidetector Computed Tomography
           (MDCT) of the pancreas.

        2. To demonstrate that RG1068-enhanced MDCT improves image quality of the pancreas in
           patients with chronic pancreatitis.

        3. To evaluate if RG1068 enhanced MDCT results in improved delineation of structural
           abnormalities of the pancreatic duct as compared to non-enhanced MDCT.
    

Detailed Description

      Multidetector Computed Tomography (MDCT) is the mainstay of imaging for patients with acute
      or chronic pancreatitis, suspected pancreatic neoplasms and post-pancreatic surgery
      evaluation. The use of multidetector row helical CT scanners and sub-second gantry rotations,
      have dramatically reduced scan acquisition time with resultant improvement in patient
      compliance and image quality. The improved Z-axis (isotropic) resolution permits excellent
      image reconstructions, which play a critical role in diagnosis and staging of pancreatic
      pathologies, due to the anatomic layout of the pancreas and its vasculature. Fast scanning
      time enables the acquisition of multiple phases of enhancement, which is of paramount
      importance in imaging the pancreas [1].

      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 [2], and the cost of ERCP is relatively high.

      Secretin enhanced MRCP (S-MRCP) has been extensively used in assessment of suspected
      pancreatic diseases. Likewise, administration of secretin intravenously to patients
      undergoing MDCT for the pancreas will result in improved distension of the pancreatic duct.
      The potential benefits of this would be a non-invasive evaluation of the pancreatic duct
      morphology. In patients with suspected abnormality involving the main duct or its side
      branches, the improved distension of the duct is likely to improve diagnostic yield for
      conditions such as intraductal papillary mucinous neoplasms (IPMNs) and cystic pancreatic
      neoplasms.

      This study is being undertaken to prospectively assess the effectiveness of RG1068-enhanced
      MDCT relative to unenhanced MDCT. 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

MDCT-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.

Secondary Outcome

 Laboratory

Condition

Chronic Pancreatitis

Intervention

RG1068 (Synthetic Human Secretin)

Study Arms / Comparison Groups

 1
Description:  Drug + MDCT

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 older than 18 years of age

          -  Is clinically indicated for contrast-enhanced MDCT of the pancreas

          -  Scheduled for MDCT and therapeutic or diagnostic ERCP for the assessment of chronic
             pancreatitis

          -  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 urine
             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:

          -  Has no clear written indication for contrast enhanced MDCT of the pancreas

          -  Has a history of hypersensitivity to iodine-containing compounds

          -  Has congestive cardiac failure (class III-IV in accordance with the classification of
             the New York Heart Association [NYHA])

          -  Presence of a pancreatic stent

          -  Is unable to comply with the study requirements including follow-up

          -  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
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Dushyant V Sahani, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00620919

Organization ID

2006P002501



Study Sponsor

Massachusetts General Hospital


Study Sponsor

Dushyant V Sahani, Principal Investigator, Massachusetts General Hospital


Verification Date

January 2009