Validation Study of Combined Positron Emission Tomography/Computer Tomography to Diagnose Infection and Inflammation

Terminated

• Conditions: Bacteremia; Gram-Positive Bacterial Infections; Inflammation; Bacterial Infections

• Registration Number: NCT00835783
• Lead Sponsor: Odense University Hospital

Brief Summary

The overall aim is to validate the current use of FDG PET/CT for the diagnosis of infection and inflammation and examine the usefulness of PET/CT applying also other tracers.

The results should allow us to confirm our primary hypothesis: "FDG-PET/CT is better than established methods to confirm or exclude the diagnosis of infection/inflammation".

Detailed Description

The study include several part projects, each contributing to the evaluation of the value of FDG-PET/CT in the diagnosis of infection and inflammation. The aims are to establish the diagnostic value in terms of sensitivity, specificity, positive and negative predictive values, interobserver and intraobserver variation.

Part project A FDG-PET/CT in patients with blood culture positive for staphylococcus aureus and unresolved origin of infection.

Part project B FDG-PET/CT in patients with fever of unknown origin.

Part project C FDG-PET/CT in patients suspected of vascular graft infection.

Additionally, we wish to establish an optimal imaging protocol (necessity of fasting, consequences of antibiotic therapy prior to imaging, and the need of contrast), interpretation criteria, and the value of standard uptake values (SUV).

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-26
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Part project A

• Blood culture positive for staphylococcus aureus and unresolved origin of infection.

Part project B

• Fever of unknown origin
• Referred for FDG-PET/CT at the Department of Nuclear Medicine, Odense University Hospital.

Part project C

• Suspected vascular graft infection
• Referred for FDG-PET/CT at the Department of Nuclear Medicine, Odense University Hospital.

Read More

Exclusion Criteria

• Patients incapable of giving, refusing or revoking consent
• Patients less than 18 years of age
• Patients from other regions than the Region of Southern Denmark
• Patients who cannot cooperate to PET/CT scan.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy	During diagnostic workup	Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy.

Trial Locations

Locations (1)

Odense University Hospital, Dept. of Nuclear Medicine; 🇩🇰 Odense, Denmark