Validation Study of Combined Positron Emission Tomography... | NCT00835783

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

NCT00835783

Sponsor

Odense University Hospital

Status

Terminated

Last Update Posted

Oct 28, 2014Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Bacterial Infections
Bacteremia
Gram-Positive Bacterial Infections
Inflammation

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study logistics proved difficult and enrollment never moved beyond the pilot phase.

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Feb 3, 2009

First Submission Date that Met QC Criteria

Feb 3, 2009

First Posted Date

Feb 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2014

Last Update Posted Date

Oct 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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".

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy	Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy.	During diagnostic workup

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Søren Hess, MD	Odense University Hospital, Dept. of Nuclear Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital, Dept. of Nuclear Medicine		Odense		5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001424	Bacterial Infections
D016470	Bacteremia
D016908	Gram-Positive Bacterial Infections
D007249	Inflammation

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D018805	Sepsis
D018746	Systemic Inflammatory Response Syndrome

Browse Leaves

Not provided

Browse Branches

Not provided