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Clinical Trial Record

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CT Pancreas Perfusion

2006-04

2009-02

2009-02

30

Study Overview

CT Pancreas Perfusion

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.

N/A

  • Pancreatic Ductal Adenocarcinoma
  • Chronic Pancreatitis
  • Autoimmune Pancreatitis
  • DEVICE: Mayo Interactive Breath Hold Monitor
  • 360-06

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2007-12-24  

N/A  

2015-04-14  

2007-12-24  

N/A  

2015-04-15  

2008-01-08  

N/A  

2015-04  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/ArmIntervention/Treatment
: 1

Suspected pancreatic ductal adenocarcinoma.

DEVICE: Mayo Interactive Breath Hold Monitor

  • Biofeedback device
: 2

Chronic pancreatitis and slated for decompression treatment.

DEVICE: Mayo Interactive Breath Hold Monitor

  • Biofeedback device
: 3

Autoimmune pancreatitis.

DEVICE: Mayo Interactive Breath Hold Monitor

  • Biofeedback device
Primary Outcome MeasuresMeasure DescriptionTime Frame
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.Three weeks to three months for chronic pancreatitis.
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Naoki Takahashi, M.D., Mayo Clinic

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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