Clinical trial NCT00590395: FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis
Official title: The Utility of FDG-PET and PET/CT in the Evaluation of Patients With Suspected Cholecystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Keywords: Cholecystitis
FDG PET/CT
HIDA scan
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis
timeFrame: 1-2 days through the post operative period
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Alan D. Waxman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: