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Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00587132
Recruitment Status : Terminated (Lack of funding)
First Posted : January 7, 2008
Results First Posted : June 20, 2013
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Synthetic Human Secretin Phase 1 Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study Using Secretin and Iodinated Intravenous Contrast and 64-Channel CT in Patients at High Risk for Pancreatic Adenocarcinoma
Study Start Date : November 2006
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: New Onset Diabetes

Adults diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Drug: Synthetic Human Secretin
0.2mcg/kg one time dose.
Other Name: ChiRhoStim
Experimental: Familial Pancreatic Cancer

Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Drug: Synthetic Human Secretin
0.2mcg/kg one time dose.
Other Name: ChiRhoStim
Experimental: Peutz-Jeghers Syndrome

Adults age 35-99 with Peutz-Jeghers syndrome.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Drug: Synthetic Human Secretin
0.2mcg/kg one time dose.
Other Name: ChiRhoStim
Experimental: Clinical Symptoms of Pancreatic Cancer, Normal CT

Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Drug: Synthetic Human Secretin
0.2mcg/kg one time dose.
Other Name: ChiRhoStim


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persons 50 years or older with recently diagnosed diabetes (within 2 years), with at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum CA 19-9, or those undergoing EUS with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening ; OR
  • Persons 35 years old or older with familial pancreatic cancer with 2 or more first degree relatives with pancreatic cancer; OR
  • Persons 35 years old or older with Peutz-Jeghers syndrome; OR
  • Persons 35 years old or older with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.

Exclusion Criteria:

  • Persons with contraindication to iodinated contrast
  • Allergy to iodinated contrast
  • Renal insufficiency (serum creatinine > 1.5 mg/dl)
  • Patients with contraindication to ionizing radiation
  • Pregnancy
  • Patients with previous pancreatic surgery
  • Contraindication to secretin
  • Allergy to secretin
  • Acute pancreatitis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587132


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
ChiRhoClin, Inc.
Investigators
Principal Investigator: Naoki Takahashi, M.D. Mayo Clinic
More Information

Responsible Party: Naoki Takahashi, Associate Professor of Radiology,College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587132     History of Changes
Other Study ID Numbers: 231-06
First Posted: January 7, 2008    Key Record Dates
Results First Posted: June 20, 2013
Last Update Posted: June 24, 2013
Last Verified: June 2013

Keywords provided by Naoki Takahashi, Mayo Clinic:
Diabetes mellitus
Peutz-Jeghers syndrome

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs