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| Sponsored by: |
Odense University Hospital |
|---|---|
| Information provided by: | Odense University Hospital |
| ClinicalTrials.gov Identifier: | NCT00835783 |
Purpose
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 |
|---|
|
Bacterial Infections Bacteremia Gram-Positive Bacterial Infections Inflammation |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | PET/CT in Infection and Inflammation Imaging: Current Utility and Future Perspectives (The PIN-UP Study) |
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
Part project A
Part project B
Part project C
Exclusion Criteria:
Contacts and Locations| Contact: Søren Hess, MD | (+45) 22 97 91 19 | hess@dadlnet.dk |
| Denmark | |
| Odense University Hospital, Dept. of Nuclear Medicine | Recruiting |
| Odense, Denmark, 5000 | |
| Principal Investigator: Søren Hess, MD | |
| Principal Investigator: | Søren Hess, MD | Odense University Hospital, Dept. of Nuclear Medicine |
More Information
| Responsible Party: | Odense University Hospital, Dept. of Nuclear Medicine ( Søren Hess, MD ) |
| Study ID Numbers: | 105-K20 |
| Study First Received: | February 3, 2009 |
| Last Updated: | February 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00835783 History of Changes |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
|
Systemic Inflammatory Response Syndrome Bacterial Infections Sepsis |
Gram-Positive Bacterial Infections Bacteremia Inflammation |
|
Systemic Inflammatory Response Syndrome Bacterial Infections Communicable Diseases Sepsis Gram-Positive Bacterial Infections |
Pathologic Processes Bacteremia Infection Inflammation |
