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

This study has been terminated.
(Study logistics proved difficult and enrollment never moved beyond the pilot phase.)
Sponsor:
Information provided by (Responsible Party):
Søren Hess, MD, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00835783
First received: February 3, 2009
Last updated: October 26, 2014
Last verified: October 2014
  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: 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)

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Efficacy [ Time Frame: During diagnostic workup ] [ Designated as safety issue: No ]
    Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy.


Enrollment: 30
Study Start Date: November 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Søren Hess, MD, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00835783     History of Changes
Other Study ID Numbers: 105-K20
Study First Received: February 3, 2009
Last Updated: October 26, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on October 29, 2014