FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis
Primary Purpose
Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
18FDG (an FDA-approved radiopharmaceutical)
Sponsored by
About this trial
This is an interventional other trial for Cholecystitis focused on measuring Cholecystitis, FDG PET/CT, HIDA scan
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
Sites / Locations
- Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FDG-PET/CT to determine Cholecystitis
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00590395
First Posted
December 26, 2007
Last Updated
December 3, 2019
Sponsor
Alan D. Waxman, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00590395
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alan D. Waxman, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis
Keywords
Cholecystitis, FDG PET/CT, HIDA scan
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FDG-PET/CT to determine Cholecystitis
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
18FDG (an FDA-approved radiopharmaceutical)
Other Intervention Name(s)
2-deoxy-2-[18F] fluoro-D-glucose (18FDG)
Intervention Description
Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of FDG PET/CT and Tc99mHIDA in the Evaluation of Subjects Suspected of Cholecystitis
Description
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.
Time Frame
1-2 days through the post operative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan D. Waxman, M.D.
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis
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