Positron Emission Tomography of Infection and Vasculitis (PETU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Turku University Hospital
Sponsor:
Information provided by (Responsible Party):
Anne Roivainen, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01878721
First received: June 10, 2013
Last updated: June 14, 2013
Last verified: June 2013
  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 Turku University Hospital:

Primary Outcome Measures:
  • Detection of infection or vasculitis in PET images [ Time Frame: within 1 week after starting the treatment ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 117
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878721

Contacts
Contact: Ulla Hohenthal, MD, PhD ulla.hohenthal@tyks.fi
Contact: Laura Pirilä, MD, PhD laura.pirila@tyks.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland, FI-20521
Contact: Ulla Hohenthal, MD, PhD       ulla.hohenthal@tyks.fi   
Contact: Laura Pirilä, MD, PhD       laura.pirila@tyks.fi   
Sub-Investigator: Anne Roivainen, PhD         
Sponsors and Collaborators
Turku University Hospital
  More Information

No publications provided

Responsible Party: Anne Roivainen, professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01878721     History of Changes
Other Study ID Numbers: 14824
Study First Received: June 10, 2013
Last Updated: June 14, 2013
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 01, 2014