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

This study has been completed.
Sponsor:
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00590395
First received: December 26, 2007
Last updated: August 24, 2010
Last verified: December 2007
  Purpose

This is a pilot study to investigate the ability of FDG-PET and PET/CT as a direct method of detecting infection and/or inflammation of the gallbladder.


Condition Intervention
Cholecystitis
Drug: 18FDG (an FDA-approved radiopharmaceutical)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Utility of FDG-PET and PET/CT in the Evaluation of Patients With Suspected Cholecystitis

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of false positives or negatives as validated by gallbladder surgery. [ Time Frame: through the post operative period ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2007
Study Completion Date: July 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)

Detailed Description:

HIDA 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590395

Locations
United States, California
Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Alan D. Waxman, M.D. Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Alan D. Waxman, M.D., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00590395     History of Changes
Other Study ID Numbers: CSMC IRB Pro00007311, CSMC216788
Study First Received: December 26, 2007
Last Updated: August 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Cholecystitis
FDG PET/CT
HIDA scan

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014