FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis

This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a direct method of detecting infection and/or inflammation of the gallbladder.

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center

Los Angeles, California, 90048, United States

About this study

Hepatobiliary iminodiacetic acid (HIDA) scan scintigraphy is a nuclear medicine scan used to evaluate patients suspected of having acute cholecystitis (infection/inflammation of the gallbladder). Because it is an indirect test that looks for obstruction of the cystic duct structure, there are many causes for a false-positive HIDA study. There is a need for a more sensitive and specific test that can accurately assess gallbladder infection and/or inflammation.

The purpose of this study is to determine the effectiveness of fluorodeoxyglucose (FDG) as a direct means of detecting patients with acute cholecystitis. FDG is an imaging agent that has previously been shown to accumulate in areas of infection and/or inflammation. The location and intensity of FDG accumulation in the body can be detected with a camera system called a "positron emission tomography" (PET) camera. In theory, this test should be effective in detecting acute infection and/or inflammation of the gallbladder.

Consenting participants will receive injection of FDG one hour prior to the FDG-PET/CT examination. The participant will then be imaged using a PET/CT machine, which is a special camera system that is capable of performing both a PET and CT scan at the same time. A CT scan is an anatomical imaging test and, for this research study, will mainly be used to localize the area of 18FDG accumulation recorded by the PET scan. The examination will take approximately one hour.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

known or high suspicion of cholecystitis
highly likely to undergo cholecystectomy
positive HIDA study
age >18 years old
provide written informed consent

Exclusion criteria

highly unlikely to proceed to surgery or biopsy
received an investigational drug within the past 30 days
pregnant or lactating
decline to provide written informed consent

Treatment and study plan

18FDG (an FDA-approved radiopharmaceutical)

Drug

Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration

Other names: 2-deoxy-2-[18F] fluoro-D-glucose (18FDG)

Primary outcomes

Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis

Time frame: 1-2 days through the post operative period
Percent of patients identified of having cholecystitis using FDG PET/CT compared to patients identified of having pathological diagnosis of cholecystitis (sensitivity) Percent of patients identified of not having cholecystitis using FDG PET/CT compared to patients identified of not having pathological diagnosis of cholecystitis (specificity)
- number of false positives = number of patients incorrectly identified of having cholecystitis using FDG PET/CT compared to a negative pathological diagnosis.
- number of false negatives = number of patients incorrectly identified of not having cholecystitis using FDG PET/CT compared to a positive pathological diagnosis.
- number of true positives = number of patients correctly identified of having cholecystitis using FDG PET/CT compared to a positive pathological diagnosis.
- number of true negatives = number of patients correctly identified of not having cholecystitis using FDG PET/CT compared to a negative pathological diagnosis.

Sponsors and collaborators

Lead sponsor

Alan D. Waxman, M.D.

Other

Registry information

Official study title

The Utility of FDG-PET and PET/CT in the Evaluation of Patients With Suspected Cholecystitis

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Jan 10, 2008
Registry last updated: Dec 10, 2019

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.

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Completed