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Secretin Enhanced MRCP for Evaluation of the Known or Suspected Intraductal Papillary Mucinous Neoplasms of the Pancreas

2014-08-27 03:32:44 | BioPortfolio

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 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

Description

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.

Study Design

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

Conditions

Intraductal Papillary Mucinous Neoplasms

Intervention

RG1068 (Synthetic Human Secretin)

Location

Massachusetts General Hospital
Boston
Massachusetts
United States
02114

Status

Terminated

Source

Massachusetts General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:44-0400

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Medical and Biotech [MESH] Definitions

A cystic tumor of the ovary, containing thin, clear, yellow serous fluid and varying amounts of solid tissue, with a malignant potential several times greater than that of mucinous cystadenoma (CYSTADENOMA, MUCINOUS). It can be unilocular, parvilocular, or multilocular. It is often bilateral and papillary. The cysts may vary greatly in size. (Dorland, 27th ed; from Hughes, Obstetric-Gynecologic Terminology, 1972)

Neoplasms containing cyst-like formations or producing mucin or serum.

Gram-negative bacterial secretion systems which carry out the secretion of folded proteins.T2SSs secrete folded proteins from the PERIPLASMIC SPACE that have been exported there by SEC TRANSLOCASE or TAT SECRETION SYSTEMS, or they secrete folded proteins directly from the CYTOPLASM. The T2SSs have four substructures, an ATPase, an inner membrane platform, a pseudopilin, and secretin, an outer membrane complex which is a channel for secretion. (This bacterial secretin is not the same as the mammalian hormone also named SECRETIN.)

A condition characterized by poorly-circumscribed gelatinous masses filled with malignant mucin-secreting cells. Forty-five percent of pseudomyxomas arise from the ovary, usually in a mucinous cystadenocarcinoma (CYSTADENOCARCINOMA, MUCINOUS), which has prognostic significance. Pseudomyxoma peritonei must be differentiated from mucinous spillage into the peritoneum by a benign mucocele of the appendix. (Segen, Dictionary of Modern Medicine, 1992)

A thyroid neoplasm of mixed papillary and follicular arrangement. Its biological behavior and prognosis is the same as that of a papillary adenocarcinoma of the thyroid. (From DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1271)

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