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CT Pancreas Perfusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588367
First Posted: January 8, 2008
Last Update Posted: April 15, 2015
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.
Information provided by (Responsible Party):
Naoki Takahashi, Mayo Clinic
  Purpose
  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 Intervention
Pancreatic Ductal Adenocarcinoma Chronic Pancreatitis Autoimmune Pancreatitis Device: Mayo Interactive Breath Hold Monitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study

Resource links provided by NLM:


Further study details as provided by Naoki Takahashi, Mayo Clinic:

Primary Outcome Measures:
  • 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. ]

Enrollment: 30
Study Start Date: April 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00588367


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

Additional Information:
Responsible Party: Naoki Takahashi, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588367     History of Changes
Other Study ID Numbers: 360-06
First Submitted: December 24, 2007
First Posted: January 8, 2008
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by Naoki Takahashi, Mayo Clinic:
Inflammation
Pancreas
Chronic pancreatitis
Alcoholic pancreatitis
Carcinoma, pancreatic ductal
Pancreatic neoplasms

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatitis
Pancreatitis, Chronic
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatic Diseases
Digestive System Diseases