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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Ductal Adenocarcinoma Adenocarcinoma Alcohol-Induced Disorders Alcohol-Related Disorders Autoimmune Diseases Autoimmune Pancreatitis Carcinoma Carcinoma, Ductal Carcinoma, Pancreatic Ductal Chemically-Induced Disorders Chronic Disease Chronic Pancreatitis Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Immune System Diseases Inflammation Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms Pancreatitis Pancreatitis, Alcoholic Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

a. Suspected pancreatic adenocarcinoma, age 35 to 99 years.
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.

b. Pancreatic ductal adenocarcinoma tumors less than 2 cm in size.
a. Chronic pancreatitis with diffuse and extensive pancreatic calcification.
a. Autoimmune pancreatitis with a prior pancreas surgery or steroid treatment for autoimmune pancreatitis .

Any Cohort:

Pregnant.

Prior iodine contrast reactions.

Iodine allergy.

Decreased kidney function being a serum creatinine greater than 1.5mg/dl.

Any contraindication to having a CT scan with iodine contrast.

Treatment and study plan

Mayo Interactive Breath Hold Monitor

Device

Biofeedback device

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

CT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility Study

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Jan 8, 2008
Registry last updated: Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed