Validation Study of Combined Positron Emission Tomography/Computer Tomography to Diagnose Infection and Inflammation (PIN-UP)
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|ClinicalTrials.gov Identifier: NCT00835783|
Recruitment Status : Terminated (Study logistics proved difficult and enrollment never moved beyond the pilot phase.)
First Posted : February 4, 2009
Last Update Posted : October 28, 2014
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".
|Condition or disease|
|Bacterial Infections Bacteremia Gram-Positive Bacterial Infections Inflammation|
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 Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||PET/CT in Infection and Inflammation Imaging: Current Utility and Future Perspectives (The PIN-UP Study)|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Patients with fever of unknown origin undergoing FDG-PET/CT as part of work-up.
Patients with bacteremia of unknown origin undergoing FDG-PET/CT as part of work-up.
Patients with vascular graft infections undergoing FDG-PET/CT as part of work-up.
- Efficacy [ Time Frame: During diagnostic workup ]Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835783
|Odense University Hospital, Dept. of Nuclear Medicine|
|Odense, Denmark, 5000|
|Principal Investigator:||Søren Hess, MD||Odense University Hospital, Dept. of Nuclear Medicine|