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

Inflammation Clinical Trial

— PIN-UP  

Official title:

PET/CT in Infection and Inflammation Imaging: Current Utility and Future Perspectives (The PIN-UP Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00835783
• Other study ID #: 105-K20
• Status: Terminated
• Phase: N/A
• First received: February 3, 2009
• Last updated: October 26, 2014
• Start date: November 2008
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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".

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacteremia
• Bacterial Infections
• Communicable Diseases
• Gram-Positive Bacterial Infections
• Infection
• Inflammation

Locations

Country	Name	City	State
Denmark	Odense University Hospital, Dept. of Nuclear Medicine	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy.	During diagnostic workup	No