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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
Sponsor:
Information provided by (Responsible Party):
Søren Hess, MD, Odense University Hospital

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".


Condition or disease
Bacterial Infections Bacteremia Gram-Positive Bacterial Infections 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).


Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PET/CT in Infection and Inflammation Imaging: Current Utility and Future Perspectives (The PIN-UP Study)
Study Start Date : November 2008
Primary Completion Date : December 2013
Study Completion Date : December 2013

Group/Cohort
FUO
Patients with fever of unknown origin undergoing FDG-PET/CT as part of work-up.
BUO
Patients with bacteremia of unknown origin undergoing FDG-PET/CT as part of work-up.
VGI
Patients with vascular graft infections undergoing FDG-PET/CT as part of work-up.



Primary Outcome Measures :
  1. Efficacy [ Time Frame: During diagnostic workup ]
    Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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.

Information from the National Library of Medicine

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


Locations
Denmark
Odense University Hospital, Dept. of Nuclear Medicine
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Søren Hess, MD Odense University Hospital, Dept. of Nuclear Medicine

Responsible Party: Søren Hess, MD, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00835783     History of Changes
Other Study ID Numbers: 105-K20
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Infection
Communicable Diseases
Inflammation
Bacterial Infections
Bacteremia
Gram-Positive Bacterial Infections
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome