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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 detection and characterization of intraductal papillary mucinous neoplasms (IPMN) relative to unenhanced MRCP in patients with suspected IPMN
3. To correlate findings on MRCP with histologically confirmed malignancy
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, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intraductal Papillary Mucinous Neoplasms
RG1068 (Synthetic Human Secretin)
Massachusetts General Hospital
Massachusetts General Hospital
Published on BioPortfolio: 2014-08-27T03:32:44-0400
The purpose of this study is to evaluate the safety and effectiveness of RG1068 (synthetic human secretin) with MRCP in subjects with abnormalities of the pancreas.
The purpose of the study is to determine the effect of multiple doses of secretin on autism.
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The aim of our study is to evaluate the utility of secretin-enhanced MRI (S-MRI) in detecting and measuring pancreatic lesions in patients with known adenocarcinoma or Intraductal papillar...
Intraductal papillary mucinous neoplasms (IPMN) have a potential to develop into a malignant disease with varying severity. Decision making on when and how to make a therapeutic interventi...
The objective of our study was to test for the possibility that published malignancy risks for side-branch intraductal papillary mucinous neoplasms (IPMNs) are overestimates, likely due to verificatio...
Intraductal papillary-mucinous neoplasms (IPMNs) are potentially malignant intraductal epithelial neoplasms that sometimes penetrate into other organs. To the best of our knowledge, no report has yet ...
Current standard-of-care technologies such as imaging and cyst fluid analysis are unable to consistently distinguish intraductal papillary mucinous neoplasms of the pancreas (IPMN) at high-risk of pan...
Management of intraductal papillary mucinous neoplasm (IPMN) is currently based on consensus, in the absence of evidence-based guidelines. In recent years, several consensus guidelines have been publi...
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