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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00835783
Other study ID # 105-K20
Secondary ID
Status Terminated
Phase N/A
First received February 3, 2009
Last updated October 26, 2014
Start date November 2008
Est. completion date December 2013

Study information

Verified date October 2014
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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".


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).


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Odense University Hospital, Dept. of Nuclear Medicine Odense

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy. During diagnostic workup No
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