Clinical Trial: Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Pilot Study Using Secretin and Iodinated Intravenous Contrast and 64-Channel CT in Patients at High Risk for Pancreatic Adenocarcinoma

Brief Summary: The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.

Detailed Summary:

Pancreatic cancer is the fourth most common cause of cancer death in the US. Because patients with pancreatic cancer rarely presents with disease specific symptoms until late in the course of the disease, identifying and developing surveillance strategies for early detection of asymptomatic pancreatic cancer is critical. EUS and fine needle aspirate (FNA) are currently the most accurate non-operative methods of establishing the presence or absence of pancreatic cancer.

The CT findings of pancreatic cancer include an attenuation difference between the pancreatic mass and the surrounding pancreatic parenchyma, pancreatic ductal dilation and cutoff, disruption of the normal fatty marbling of the pancreatic parenchyma, rounding of the inferior margin of the posterior head of the pancreas, atrophy of the proximal gland, and signs of locally advanced or distant disease. In a case-controlled retrospective review of pancreatic cancers missed at CT prior to clinical presentation at the Mayo Clinic, Gangi et al found that CT findings definite or suspicious for pancreatic cancer were present in 50% of scans obtained up to 18 months before the clinical diagnosis of pancreatic cancer. Pancreatic duct dilation and cutoff were early CT findings indicating tumor presence, and were associated with near-perfect and substantial interobserver agreement. Consequently, early pancreatic neoplasms likely result in at least partial occlusion of the duct, leading to subsequent ductal dilation.

We hypothesize that increased production of the pancreatic juice distends the otherwise small caliber pancreatic duct, and accentuate the secondary sign of pancreatic duct obstruction by a small pancreatic mass. The investigators will be able to take advantage of this physiologic effect of secretin, by obtaining multi-planar scans with isotropic resolution us
Sponsor: Mayo Clinic

Current Primary Outcome: Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT. [ Time Frame: Day 1 of study ]

Subjects will receive the secretin test dose just prior to the CT scan. Definitions: Evidence of Pancreatic Tumor (low-attenuation mass), Secondary Findings of Pancreatic Tumor such as dilated pancreatic duct or liver masses suggestive of liver metastases.


Original Primary Outcome: If the CT shows evidence of pancreatic tumor or any secondary findings of pancreatic tumor, the patient will undergo EUS with or without FNA, unless the patient has had EUS within one week before the CT. [ Time Frame: Two weeks ]

Current Secondary Outcome:

Original Secondary Outcome: The reference standard for presence of malignant tumor will be histologic confirmation for or clear-cut evidence of progression of the disease based on a follow-up CT scan at 3 and 18months. [ Time Frame: Three and eighteen months ]

Information By: Mayo Clinic

Dates:
Date Received: December 21, 2007
Date Started: November 2006
Date Completion:
Last Updated: June 19, 2013
Last Verified: June 2013