CT Pancreas Perfusion

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Brief Title

CT Pancreas Perfusion

Official Title

CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study

Brief Summary

      1. Pancreatic CT perfusion with a biofeedback breathing belt worn by the participant, and
           using novel post-processing techniques, is a reliable method which can be used to
           differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune
           pancreatitis.

        2. Pancreatic CT perfusion can be used to monitor patients undergoing decompression
           treatment (endoscopic retrograde cholangiopancreatography with stent placement) for
           painful chronic pancreatitis, and the change in the pancreatic perfusion parameters
           correlate with the change in the pain parameters (pain scale and analgesic use).

        3. Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at
           specific time points to replace the continuous scanning.
    



Study Type

Observational


Primary Outcome

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.


Condition

Pancreatic Ductal Adenocarcinoma

Intervention

Mayo Interactive Breath Hold Monitor

Study Arms / Comparison Groups

 1
Description:  Suspected pancreatic ductal adenocarcinoma.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

30

Start Date

April 2006

Completion Date

February 2009

Primary Completion Date

February 2009

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Naoki Takahashi, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00588367

Organization ID

360-06


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic


Study Sponsor

Naoki Takahashi, M.D., Principal Investigator, Mayo Clinic


Verification Date

April 2015