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FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis

NCT ID: NCT00590395

Last Updated: 2019-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Cholecystitis

Keywords

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Cholecystitis FDG PET/CT HIDA scan

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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FDG-PET/CT to determine Cholecystitis

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.

Group Type EXPERIMENTAL

18FDG (an FDA-approved radiopharmaceutical)

Intervention Type DRUG

Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration

Interventions

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18FDG (an FDA-approved radiopharmaceutical)

Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration

Intervention Type DRUG

Other Intervention Names

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2-deoxy-2-[18F] fluoro-D-glucose (18FDG)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alan D. Waxman, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Alan D. Waxman, M.D.

Director, Imaging / Nuclear Medicine / Nuclear Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alan D. Waxman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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CSMC216788

Identifier Type: OTHER

Identifier Source: secondary_id

CSMC IRB Pro00007311

Identifier Type: -

Identifier Source: org_study_id