Clinical trial NCT00835783: Validation Study of Combined Positron Emission Tomography/Computer Tomography to Diagnose Infection and Inflammation
Official title: PET/CT in Infection and Inflammation Imaging: Current Utility and Future Perspectives (The PIN-UP Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bacterial Infections
Bacteremia
Gram-Positive Bacterial Infections
Inflammation
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are referred for FDG-PET/CT at the Department of Nuclear Medicine, Odense University Hospital. Patients are recruited for part project A from the entire hospital through a project nurse at the Department of Infectious Diseases. Patients are recruited for part project B and part project C among all patients referred for FDG-PET/CT as per usual guidelines.

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).

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.

Primary outcomes:
measure: Efficacy
timeFrame: During diagnostic workup
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital, Dept. of Nuclear Medicine
Study officials:
affiliation: Odense University Hospital, Dept. of Nuclear Medicine
name: Søren Hess, MD
role: PRINCIPAL_INVESTIGATOR
References: