Brief Title
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
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.
Study Type
Interventional
Primary Outcome
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis
Condition
Cholecystitis
Intervention
18FDG (an FDA-approved radiopharmaceutical)
Study Arms / Comparison Groups
FDG-PET/CT to determine Cholecystitis
Description: 19 patients with suspected acute cholecystitis and a positive HIDA will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG PET/CT exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
19
Start Date
July 2007
Completion Date
July 2010
Primary Completion Date
January 2010
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Alan D. Waxman, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00590395
Organization ID
CSMC IRB Pro00007311
Secondary IDs
CSMC216788
Responsible Party
Sponsor-Investigator
Study Sponsor
Alan D. Waxman, M.D.
Study Sponsor
Alan D. Waxman, M.D., Principal Investigator, Cedars-Sinai Medical Center
Verification Date
December 2019