Validation Study of Combined Positron Emission Tomography/Computer Tomography to Diagnose Infection and Inflammation

NCT00835783 | Terminated

• 1 other identifier: 105-K20
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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".

Conditions

Bacterial Infections; Bacteremia; Gram-Positive Bacterial Infections; Inflammation

Outcome Measures

Primary Outcomes (1)

• Efficacy

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

  During diagnostic workup

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital, Dept. of Nuclear Medicine

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Bacterial Infections; Bacteremia; Gram-Positive Bacterial Infections; Inflammation

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Søren Hess, MD

  Odense University Hospital, Dept. of Nuclear Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: November 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

DK (1)