CT Pancreas Perfusion

Completed

• Conditions: Pancreatic Ductal Adenocarcinoma; Chronic Pancreatitis; Autoimmune Pancreatitis
• Interventions: Device: Mayo Interactive Breath Hold Monitor

• Registration Number: NCT00588367
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-12-24
• Study First Submitted QC: 2007-12-24
• Study First Posted: 2008-01-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Mayo Interactive Breath Hold Monitor	Suspected pancreatic ductal adenocarcinoma.
3	Mayo Interactive Breath Hold Monitor	Autoimmune pancreatitis.
2	Mayo Interactive Breath Hold Monitor	Chronic pancreatitis and slated for decompression treatment.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States