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

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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