FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis
|ClinicalTrials.gov Identifier: NCT00590395|
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : June 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cholecystitis||Drug: 18FDG (an FDA-approved radiopharmaceutical)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Utility of FDG-PET and PET/CT in the Evaluation of Patients With Suspected Cholecystitis|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||July 2010|
20 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.
Drug: 18FDG (an FDA-approved radiopharmaceutical)
Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration
Other Name: 2-deoxy-2-[18F] fluoro-D-glucose (18FDG)
- FDG PET/CT as a direct assessment of gallbladder inflammation/infection (cholecystitis) as opposed to the HIDA scan which provides an indirect assessment. [ Time Frame: 1-2 days through the post operative period ]
- The number of false positives or negatives as validated by gallbladder surgery. [ Time Frame: 7 days following the operative procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590395
|United States, California|
|Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Alan D. Waxman, M.D.||Cedars-Sinai Medical Center|