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Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma

Pilot Study Using Secretin and Iodinated Intravenous Contrast and 64-Channel CT in Patients at High Risk for Pancreatic Adenocarcinoma

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00587132
Enrollment
4
Registered
2008-01-07
Start date
2006-11-30
Completion date
2012-02-29
Last updated
2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Diabetes mellitus, Peutz-Jeghers syndrome

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.

Detailed description

Pancreatic cancer is the fourth most common cause of cancer death in the US. Because patients with pancreatic cancer rarely presents with disease specific symptoms until late in the course of the disease, identifying and developing surveillance strategies for early detection of asymptomatic pancreatic cancer is critical. EUS and fine needle aspirate (FNA) are currently the most accurate non-operative methods of establishing the presence or absence of pancreatic cancer. The CT findings of pancreatic cancer include an attenuation difference between the pancreatic mass and the surrounding pancreatic parenchyma, pancreatic ductal dilation and cutoff, disruption of the normal fatty marbling of the pancreatic parenchyma, rounding of the inferior margin of the posterior head of the pancreas, atrophy of the proximal gland, and signs of locally advanced or distant disease. In a case-controlled retrospective review of pancreatic cancers missed at CT prior to clinical presentation at the Mayo Clinic, Gangi et al found that CT findings definite or suspicious for pancreatic cancer were present in 50% of scans obtained up to 18 months before the clinical diagnosis of pancreatic cancer. Pancreatic duct dilation and cutoff were early CT findings indicating tumor presence, and were associated with near-perfect and substantial interobserver agreement. Consequently, early pancreatic neoplasms likely result in at least partial occlusion of the duct, leading to subsequent ductal dilation. We hypothesize that increased production of the pancreatic juice distends the otherwise small caliber pancreatic duct, and accentuate the secondary sign of pancreatic duct obstruction by a small pancreatic mass. 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. Secretin is a safe agent that increases pancreatic exocrine secretion. Intravenously administered secretin increases the pancreatic juice secretion, and magnetic resonance or CT scan obtained after secretin has been shown to improve visualization of the pancreatic duct. Day 1: Patient will fast 4 hours prior to the study. 1 L of water is given by mouth as an oral contrast material 30 minutes prior to the study. After placing an angiocath in the antecubital fossa, the patient will be placed in a supine position on the CT scanner. Secretin test dose will be given intravenously (0.2mcg (0.1ml). If no reaction is noted after one minute, then Secretin will be given intravenously (0.2 mcg/kg IV slowly over one minute). If an allergic reaction is noted, the patient will not have a CT scan performed as part of this study protocol, and that participant will be ineligible to participant with this study. Secretin bolus will be terminated if Systolic BP \< 90mm/Hg is not corrected with IV fluids. Pre-contrast scan will be obtained with collimation of 0.6 x 64 mm and a pitch of 1.2 through the abdomen under deep inspiration. Images will be reconstructed with 1 mm slice thickness and 2 mm increment. Five minutes after administration of the intravenous Secretin, iodinated contrasted Omnipaque 350 administered at 3-5ml/sec. Post-iodine-contrast scanning will be obtained with collimation of 0.6 x 64 mm and a pitch of 1.2 through the abdomen with scan delays of 40- and 70-seconds. Total of 150 ml of intravenous iodinated contrast will be administered at the rate of 3 - 5 ml/ sec. For the 3 month (Day 2) and 18 month (Day 3) follow-up CT imaging: Patient will fast four hours before scan. 1 liter of water given orally 30 minutes prior to scan. An IV will be placed, and participant will have iodinated contrast (Omnipaque 350) administered at 3-5ml/sec. Post iodine scanning will be done with collimation of 0.6 x64mm and a pitch of 1.2 through the abdomen with scan delays of 40 and 70 seconds. For the optional CT scan for those who have initial positive CT: This exam is to be done only before endoscopic ultrasound (EUS). Patient will fast four hours before scan. 1 liter of water given orally 30 minutes prior to scan. An IV will be placed, and participant will have iodinated contrast (Omnipaque 350) administered at 3-5ml/sec. Post iodine scanning will be done with collimation of 0.6 x64mm and a pitch of 1.2 through the abdomen with scan delays of 40 and 70 seconds. Subjects will be followed up for 3-5 years to determine if they develop pancreatic cancer.

Interventions

0.2mcg/kg one time dose.

Sponsors

Mayo Clinic
Lead SponsorOTHER
ChiRhoClin, Inc.
CollaboratorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.Day 1 of studySubjects 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.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited from the Mayo Clinic in Rochester, Minnesota from November 2006 until April 2009.

Participants by arm

ArmCount
New Onset Diabetes
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 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.
4
Familial Pancreatic Cancer
10 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.
0
Peutz-Jeghers Syndrome
10 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.
0
Clinical Symptoms of Pancreatic Cancer, Normal CT
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.
0
Total4

Baseline characteristics

CharacteristicNew Onset DiabetesTotal
Age Categorical
<=18 years
0 participants0 participants
Age Categorical
>=65 years
2 participants2 participants
Age Categorical
Between 18 and 65 years
2 participants2 participants
Gender
Female
3 participants3 participants
Gender
Male
1 participants1 participants
Region of Enrollment
United States
4 participants4 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 40 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 40 / 00 / 00 / 0

Outcome results

Primary

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.

Time frame: Day 1 of study

Population: All subjects had a normal CT scan. The study was terminated early due to lack of funding. No analysis was done due to the low enrollment.

ArmMeasureValue (NUMBER)
New Onset DiabetesNumber of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026