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Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma

This study has been completed.
Sponsor:
Collaborator:
ChiRhoClin, Inc.
Information provided by (Responsible Party):
Naoki Takahashi, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587132
First received: December 21, 2007
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

To test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.


Condition Intervention
Diabetes Mellitus
 Drug: Synthetic Human Secretin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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)
Groups/Cohorts Assigned Interventions
1
10 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 CA 19-9, or those undergoing EUS with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.
 Drug: Synthetic Human Secretin
0.2mcg/kg one time dose.
Other Name: ChiRhoStim
2
10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer
 Drug: Synthetic Human Secretin
0.2mcg/kg one time dose.
Other Name: ChiRhoStim
3
10 adults age 35-99 with Peutz-Jeghers syndrome.
 Drug: Synthetic Human Secretin
0.2mcg/kg one time dose.
Other Name: ChiRhoStim
4
10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
 Drug: Synthetic Human Secretin
0.2mcg/kg one time dose.
Other Name: ChiRhoStim

Detailed Description:

By distending the pancreatic duct with secretin injection, we believe ductal dilation and cutoff will be accentuated. The investigators will be able to take advantage of this physiologic effect of secretin, by obtaining multi-planar scans with isotropic resolution using a 64-channel CT system.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mayo Clinic Pancreas Clinic patients

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
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
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Diabetes mellitus diagnosed within two years

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Diabetes Mellitus
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Glucose Metabolism Disorders
 Metabolic 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 June 18, 2013