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