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RG1068 (Synthetic Human Secretin) Enhanced MRCP for Morphological Evaluation of the Known or Suspected Intraductal Papillary Mucinous Neoplasms of the Pancreas

Phase 1
18 Years
90 Years
Not Enrolling
Intraductal Papillary Mucinous Neoplasms

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Trial Information

RG1068 (Synthetic Human Secretin) Enhanced MRCP for Morphological Evaluation of the Known or Suspected Intraductal Papillary Mucinous Neoplasms of the Pancreas

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 for the evaluation of patients with known or suspected
IPMN. 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 MRCP of the pancreas based on prior imaging features
suggestive or suspicious of IPMN (eg. Cystic lesion in the pancreas along the duct,
ductal dilatation)

- Scheduled for MRCP and therapeutic or diagnostic ERCP or surgery for the IPMN

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

MR & 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.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Dushyant V Sahani

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

December 2008

Related Keywords:

  • Intraductal Papillary Mucinous Neoplasms
  • Neoplasms
  • Pancreatic Neoplasms



Massachusetts General HospitalBoston, Massachusetts  02114-2617