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

Study Overview
=================
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).

Official Title
-----------------
PET/CT in Infection and Inflammation Imaging: Current Utility and Future Perspectives (The PIN-UP Study)

Conditions
-----------------
Bacterial Infections, Bacteremia, Gram-Positive Bacterial Infections, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FUO<br>Patients with fever of unknown origin undergoing FDG-PET/CT as part of work-up. | |
| BUO<br>Patients with bacteremia of unknown origin undergoing FDG-PET/CT as part of work-up. | |
| VGI<br>Patients with vascular graft infections undergoing FDG-PET/CT as part of work-up. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy. | During diagnostic workup |