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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-12-31

Brief Summary

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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".

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Detailed Description

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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).

Conditions

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Bacterial Infections Bacteremia Gram-Positive Bacterial Infections Inflammation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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FUO

Patients with fever of unknown origin undergoing FDG-PET/CT as part of work-up.

No interventions assigned to this group

BUO

Patients with bacteremia of unknown origin undergoing FDG-PET/CT as part of work-up.

No interventions assigned to this group

VGI

Patients with vascular graft infections undergoing FDG-PET/CT as part of work-up.

No interventions assigned to this group

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No