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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 April 2015 |
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Main ID: |
NCT00588367 |
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Date of registration:
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24/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CT Pancreas Perfusion
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Scientific title:
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CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00588367 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Naoki Takahashi, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pancreatic Ductal Adenocarcinoma
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Autoimmune Pancreatitis
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Chronic Pancreatitis
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Intervention(s)
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Device: Mayo Interactive Breath Hold Monitor
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Primary Outcome(s)
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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.
[Time Frame: Three weeks to three months for chronic pancreatitis.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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