Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma

This study has been terminated.
(Lack of funding)
Sponsor:
Collaborator:
ChiRhoClin, Inc.
Information provided by (Responsible Party):
Naoki Takahashi, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587132
First received: December 21, 2007
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: Synthetic Human Secretin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 4
Study Start Date: November 2006
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 21, 2007
Results First Received: April 29, 2013
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014