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CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study


N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Ductal Adenocarcinoma, Chronic Pancreatitis, Autoimmune Pancreatitis

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Trial Information

CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study


Inclusion Criteria:



1. a. Suspected pancreatic adenocarcinoma, age 35 to 99 years.

2. a. Chronic pancreatitis with chronic pain, age 18 to 99 years. Must be a confirmed
diagnosis by either CT, endoscopic ultrasound (EUS), or endoscopic retrograde
cholangiopancreatography (ERCP).

2b. To undergo endoscopic or surgical decompression with 0 to 10 days of first study
visit CT perfusion scan.

2c. To answer pain questionnaire before first CT perfusion scan.

2d. To return within three weeks to three months after decompression treatment for
another CT perfusion scan and complete the second pain questionnaire.

3a. Autoimmune pancreatitis, age 18 to 99 years either with diffuse or focal swelling of
the pancreas confirmed by CT, MRI, or EUS or

3b. Irregular narrowing of the pancreatic duct on ERCP and either elevated serum
immunoglobulin G4 (IgG4), or histological confirmation.

Exclusion Criteria:

1a. Pancreatic ductal adenocarcinoma tumors with vascular involvement but without
vascular occlusion.

1. b. Pancreatic ductal adenocarcinoma tumors less than 2 cm in size.

2. a. Chronic pancreatitis with diffuse and extensive pancreatic calcification.

3. a. Autoimmune pancreatitis with a prior pancreas surgery or steroid treatment for
autoimmune pancreatitis .

Any Cohort:

4. Pregnant.

5. Prior iodine contrast reactions.

6. Iodine allergy.

7. Decreased kidney function being a serum creatinine greater than 1.5mg/dl.

8. Any contraindication to having a CT scan with iodine contrast.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

A reproducible technique to measure CT perfusion parameters may provide a method for non-invasively monitoring tumor response during treatment, or differentiating between autoimmune and chronic pancreatitis.

Outcome Time Frame:

Three weeks to three months for chronic pancreatitis.

Safety Issue:

No

Principal Investigator

Naoki Takahashi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

360-06

NCT ID:

NCT00588367

Start Date:

April 2006

Completion Date:

February 2009

Related Keywords:

  • Pancreatic Ductal Adenocarcinoma
  • Chronic Pancreatitis
  • Autoimmune Pancreatitis
  • Inflammation
  • Pancreas
  • Chronic pancreatitis
  • Alcoholic pancreatitis
  • Carcinoma, pancreatic ductal
  • Pancreatic neoplasms
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatitis
  • Pancreatitis, Chronic
  • Carcinoma, Ductal, Breast

Name

Location

Mayo Clinic Rochester, Minnesota  55905