Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cancer | Drug: Synthetic Human Secretin | Phase 1 Phase 2 |

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 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 2012 |

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 |
- 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.

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

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
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Naoki Takahashi, M.D. | Mayo Clinic |
Responsible Party: | Naoki Takahashi, Associate Professor of Radiology,College of Medicine, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00587132 |
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 |
Diabetes mellitus Peutz-Jeghers syndrome |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Secretin Gastrointestinal Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |