Positron Emission Tomography of Infection and Vasculitis | NCT01878721

Studies
Positron Emission Tomography of Infection and Vasculitis

NCT01878721

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

Oct 22, 2021Actual

Enrollment

117Estimated

Phase

Not provided

Conditions

Infection
Vasculitis

Interventions

PET/CT

Countries

Finland

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 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Oct 2021Actual

Completion Date

Oct 2021Actual

First Submitted Date

Jun 10, 2013

First Submission Date that Met QC Criteria

Jun 14, 2013

First Posted Date

Jun 17, 2013Estimated

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 21, 2021

Last Update Posted Date

Oct 22, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anne Roivainen, professor, Turku University HospitalPrincipal Investigator

Lead Sponsor

Turku University HospitalOTHER_GOV

Collaborators

Not provided

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 purpose of this study is to evaluate the value of positron emission tomography/computed tomography in various inflammatory conditions caused by bacterial infection or vasculitis. Glucose analog FDG is sensitive to detect inflammation foci but we hypothesize that other imaging agents such as PK11195 and Ga-citrate may have added value in certain applications.

Detailed Description

The purpose of this study is to evaluate the value of PET/CT in various inflammatory conditions caused by bacterial infection or vasculitis. Our aim is to:

investigate whether FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET/CT and 68Ga-(Gallium-68) citrate PET/CT enable the early and accurate detection of metastatic infection foci in Staphylococcus aureus bacteremia.
study the usefulness of FDG PET/CT in detection of endovascular infection in bacteremia caused by Salmonella spp.
find an optimal FDG PET/CT protocol for detection of infectious endocarditis and metastatic infection foci related to endocarditis.
study the value of FDG PET/CT in the diagnosis of infection of pacemaker or implantable cardioverter defibrillator.
investigate the usefulness of FDG PET/CT, 68Ga-citrate PET/CT, and 11C- (carbon-11) translocator protein ligand (PK11195) PET/CT in diagnosis of vasculitis and in imaging of the magnitude of the vascular changes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

117Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Staphylococcus aureus bacteremia	PET/CT in patients with Staphylococcus aureus bacteremia	Radiation: PET/CT
Salmonella spp. bacteremia	PET/CT in patients with Salmonella spp. bacteremia	Radiation: PET/CT
Endocarditis	PET/CT in patients with infective endocarditis	Radiation: PET/CT
Pacemaker infection	PET/CT in patients with pacemaker infection	Radiation: PET/CT
Vasculitis	PET/CT in patients with vasculitis	Radiation: PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/CT	Radiation	positron emission tomography/computed tomography	Endocarditis Pacemaker infection Salmonella spp. bacteremia Staphylococcus aureus bacteremia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of infection or vasculitis in PET images		within 1 week after starting the treatment

Secondary Outcomes

Measure	Description	Time Frame
Standardized uptake value of PET imaging agent at the site of infection or vasculitis		within 1 week after starting the treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults with

Staphylococcus aureus bacteremia or
Salmonella spp. bacteremia or
infective endocarditis or
infection of pacemaker or implantable cardioverter defibrillator or
vasculitis

Exclusion Criteria:

underage, pregnant, breastfeeding, handicapped or prisoner

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 of Turku University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turku University Hospital		Turku		FI-20521	Finland

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D014657	Vasculitis

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

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Browse Branches

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