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PIN-UP: Validation Study of Combined Positron Emission Tomography/Computer Tomography to Diagnose Infection and Inflammation

Sponsor
Odense University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT00835783
Collaborator
(none)
30
Enrollment
1
Location
61
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Nov 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy [During diagnostic workup]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Søren Hess, MD, MD, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT00835783
    Other Study ID Numbers:
    • 105-K20
    First Posted:
    Feb 4, 2009
    Last Update Posted:
    Oct 28, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Bacterial Infections
    Bacteremia
    Gram-Positive Bacterial Infections
    Inflammation

    Study Results

    No Results Posted as of Oct 28, 2014