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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00835783

Acronym

PIN-UP

Enrollment

Registered

2009-02-04

Start date

2008-11-30

Completion date

2013-12-31

Last updated

2014-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Denmark

Outcome results