NCT00590395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

October 17, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

2.5 years

First QC Date

December 26, 2007

Results QC Date

November 21, 2018

Last Update Submit

December 3, 2019

Conditions

Cholecystitis

Keywords

CholecystitisFDG PET/CTHIDA scan

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

FDG-PET/CT to determine Cholecystitis

EXPERIMENTAL

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.

Drug: 18FDG (an FDA-approved radiopharmaceutical)

Interventions

18FDG (an FDA-approved radiopharmaceutical)DRUG

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

Also known as: 2-deoxy-2-[18F] fluoro-D-glucose (18FDG)
FDG-PET/CT to determine Cholecystitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • known or high suspicion of cholecystitis
  • highly likely to undergo cholecystectomy
  • positive HIDA study
  • age \>18 years old
  • provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Cholecystitis

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Results Point of Contact

Title
Alan Waxman, M.D.
Organization
Cedars Sinai Medical Center
Alan.Waxman@cshs.org
310-423-8000

Study Officials

  • Alan D. Waxman, M.D.

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Imaging / Nuclear Medicine / Nuclear Cardiology

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 10, 2008

Study Start

July 1, 2007

Primary Completion

January 1, 2010

Study Completion

July 1, 2010

Last Updated

December 10, 2019

Results First Posted

October 17, 2019

Record last verified: 2019-12

Locations

US(1)