Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma

NCT00587132 | Terminated Phase 1 Results

• 1 other identifier: 231-06
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Diabetes mellitus; Peutz-Jeghers syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.

  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.

  Day 1 of study

Study Arms (4)

New Onset Diabetes

EXPERIMENTAL

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

Familial Pancreatic Cancer

EXPERIMENTAL

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

Peutz-Jeghers Syndrome

EXPERIMENTAL

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

Clinical Symptoms of Pancreatic Cancer, Normal CT

EXPERIMENTAL

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

Interventions

Synthetic Human Secretin DRUG

0.2mcg/kg one time dose.

Also known as: ChiRhoStim

Clinical Symptoms of Pancreatic Cancer, Normal CT; Familial Pancreatic Cancer; New Onset Diabetes; Peutz-Jeghers Syndrome

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• ChiRhoClin, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Diabetes Mellitus; Peutz-Jeghers Syndrome

Interventions

Secretin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplastic Syndromes, Hereditary; Intestinal Polyposis; Intestinal Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lentigo; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Limitations and Caveats

The study was terminated early due to lack of funding.

Results Point of Contact

• Title: Dr. Naoki Takahashi
• Organization: Mayo Clinic

takahashi.naoki@mayo.edu

507-284-7249

Study Officials

• Naoki Takahashi, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology,College of Medicine

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: November 1, 2006
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 24, 2013
• Results First Posted: June 20, 2013

Record last verified: 2013-06

Locations

US (1)