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CT Pancreas Perfusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00588367
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):
Naoki Takahashi, Mayo Clinic

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.

Condition or disease Intervention/treatment
Pancreatic Ductal Adenocarcinoma Chronic Pancreatitis Autoimmune Pancreatitis Device: Mayo Interactive Breath Hold Monitor

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study
Study Start Date : April 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Group/Cohort Intervention/treatment
Suspected pancreatic ductal adenocarcinoma.
Device: Mayo Interactive Breath Hold Monitor
Biofeedback device

Chronic pancreatitis and slated for decompression treatment.
Device: Mayo Interactive Breath Hold Monitor
Biofeedback device

Autoimmune pancreatitis.
Device: Mayo Interactive Breath Hold Monitor
Biofeedback device

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mayo Clinic patients being seen in Pancreas Clinic.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00588367

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Naoki Takahashi, M.D. Mayo Clinic

Additional Information:
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Responsible Party: Naoki Takahashi, Principal Investigator, Mayo Clinic Identifier: NCT00588367    
Other Study ID Numbers: 360-06
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015
Keywords provided by Naoki Takahashi, Mayo Clinic:
Chronic pancreatitis
Alcoholic pancreatitis
Carcinoma, pancreatic ductal
Pancreatic neoplasms
Additional relevant MeSH terms:
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Pancreatitis, Chronic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Diseases
Digestive System Diseases
Gastrointestinal Agents