Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma - Full Text View

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:

Genetics Home Reference related topics: Peutz-Jeghers syndrome

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Human secretin

Genetic and Rare Diseases Information Center resources: Juvenile Polyposis Syndrome Pancreatic Cancer Peutz Jeghers Syndrome

U.S. FDA Resources

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

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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:


Secretin Gastrointestinal Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists	Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015