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Clinical Trials/NCT00835783
NCT00835783
Terminated
Not Applicable

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

Odense University Hospital1 site in 1 country30 target enrollmentNovember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bacterial Infections
Sponsor
Odense University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Efficacy
Status
Terminated
Last Updated
11 years ago

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).

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
December 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Søren Hess, MD

MD

Odense University Hospital

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.

Outcomes

Primary Outcomes

Efficacy

Time Frame: During diagnostic workup

Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy.

Study Sites (1)

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