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Positron Emission Tomography of Infection and Vasculitis (PETU)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01878721
First Posted: June 17, 2013
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anne Roivainen, Turku University Hospital
  Purpose
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.

Condition Intervention
Infection Vasculitis Radiation: PET/CT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Positron Emission Tomography of Infection and Vasculitis (PETU)

Resource links provided by NLM:


Further study details as provided by Anne Roivainen, Turku University Hospital:

Primary Outcome Measures:
  • Detection of infection or vasculitis in PET images [ Time Frame: within 1 week after starting the treatment ]

Secondary Outcome Measures:
  • Standardized uptake value of PET imaging agent at the site of infection or vasculitis [ Time Frame: within 1 week after starting the treatment ]

Estimated Enrollment: 117
Study Start Date: January 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Staphylococcus aureus bacteremia
PET/CT in patients with Staphylococcus aureus bacteremia
Radiation: PET/CT
positron emission tomography/computed tomography
Salmonella spp. bacteremia
PET/CT in patients with Salmonella spp. bacteremia
Radiation: PET/CT
positron emission tomography/computed tomography
Endocarditis
PET/CT in patients with infective endocarditis
Radiation: PET/CT
positron emission tomography/computed tomography
Pacemaker infection
PET/CT in patients with pacemaker infection
Radiation: PET/CT
positron emission tomography/computed tomography
Vasculitis
PET/CT in patients with vasculitis
Radiation: PET/CT
positron emission tomography/computed tomography

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:

  1. 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.
  2. study the usefulness of FDG PET/CT in detection of endovascular infection in bacteremia caused by Salmonella spp.
  3. find an optimal FDG PET/CT protocol for detection of infectious endocarditis and metastatic infection foci related to endocarditis.
  4. study the value of FDG PET/CT in the diagnosis of infection of pacemaker or implantable cardioverter defibrillator.
  5. 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of Turku University Hospital
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878721


Locations
Finland
Turku University Hospital
Turku, Finland, FI-20521
Sponsors and Collaborators
Turku University Hospital
  More Information

Responsible Party: Anne Roivainen, professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01878721     History of Changes
Other Study ID Numbers: 14824
First Submitted: June 10, 2013
First Posted: June 17, 2013
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Anne Roivainen, Turku University Hospital:
PET/CT
infection
vasculitis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases