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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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.
Dushyant V Sahani
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|