Cholecystitis Clinical Trial
Official title:
The Utility of FDG-PET and PET/CT in the Evaluation of Patients With Suspected Cholecystitis
Verified date | December 2019 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | July 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Alan D. Waxman, M.D. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis | 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. |
1-2 days through the post operative period |
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