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Evaluation of Efficiency of Secretin-Assisted Computed Tomography Scan and Secretin-Assisted Magnetic Resonance Imaging in Improving Pancreatic Enhancement and Tumor Conspicuity: Prospective Study


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Pancreas Cancer

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Trial Information

Evaluation of Efficiency of Secretin-Assisted Computed Tomography Scan and Secretin-Assisted Magnetic Resonance Imaging in Improving Pancreatic Enhancement and Tumor Conspicuity: Prospective Study


Inclusion Criteria:



1. Patients 18 or above will be included in the study.

2. Patients suspected of pancreatic mass or with a known pancreatic mass would be
enrolled in the study.

3. Patients with suspected pancreatic pathology and scheduled for imaging study (CT vs.
MRI) will be included if they had obstructive jaundice, with either a stricture in
the lower common bile duct on magnetic resonance cholangiopancreatography (MRCP) or a
pancreatic mass on ultrasound or other imaging study.

Exclusion Criteria:

1. Patients with known advanced pancreatic tumors and those with previous pancreatic
resection will be excluded.

2. Patients with renal insufficiency: increase Cr level or glomerular filteration rate
(GFR) of less than 45 ml/min/1.73.

3. Patients who demonstrate increase in Cr level or patients with acute renal injury.

4. Claustrophobic or patients who are not able to tolerate MRI.

5. Patients with previous history of contrast allergies.

6. Pregnant patients

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Increase in pancreatic tumor conspicuity.

Outcome Description:

Quantitative analysis will be performed using CT attenuation values obtained from the pancreas and from pancreatic tumors. The average CT attenuation will be calculated for the normal pancreatic tissue and any tumor. The mean pancreatic enhancement for the pancreatic and portal venous phases will be obtained by subtracting the mean CT attenuation value on nonenhanced images from the mean CT attenuation obtained from pancreatic and portal venous phase enhanced images. Mean enhancement for the pancreatic and portal venous phases will be calculated for both secretin and nonsecretin patients.

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Pablo R Ros, MD MPH PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Case Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CC00035

NCT ID:

NCT01371240

Start Date:

June 2011

Completion Date:

June 2012

Related Keywords:

  • Pancreas Cancer
  • pancreas cancer
  • MRI
  • CT scan
  • Pancreatic Neoplasms

Name

Location

University Hospitals Case Medical CenterCleveland, Ohio  44106