InfectionPETUNCT01878721
Positron Emission Tomography of Infection and Vasculitis
An observational study of Infection and Vasculitis, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Vasculitis
- What is being tested?
- PET/CT
- Type of treatment
- Surgery or procedure
- How many people
- 117 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2011to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of Turku University Hospital
Who may be able to join
- Adults with
- Staphylococcus aureus bacteremia or
- Salmonella spp. bacteremia or
- infective endocarditis or
- infection of pacemaker or implantable cardioverter defibrillator or
- vasculitis
Who cannot join
- underage, pregnant, breastfeeding, handicapped or prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positron Emission Tomography of Infection and Vasculitis (PETU)
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.
Read the 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.
- Conditions
- Infection, Vasculitis
- Being tested
- PET/CT
- Keywords
- PET/CT, infection, vasculitis
- Medical subject headings
- Infections, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTRadiation
positron emission tomography/computed tomography
| Study group | Role | What they receive |
|---|---|---|
| Staphylococcus aureus bacteremia | PET/CT in patients with Staphylococcus aureus bacteremia Receives: Radiation: PET/CT | |
| Salmonella spp. bacteremia | PET/CT in patients with Salmonella spp. bacteremia Receives: Radiation: PET/CT | |
| Endocarditis | PET/CT in patients with infective endocarditis Receives: Radiation: PET/CT | |
| Pacemaker infection | PET/CT in patients with pacemaker infection Receives: Radiation: PET/CT | |
| Vasculitis | PET/CT in patients with vasculitis Receives: Radiation: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of infection or vasculitis in PET images
Measured: within 1 week after starting the treatment
Secondary outcomes (1)
Standardized uptake value of PET imaging agent at the site of infection or vasculitis
Measured: within 1 week after starting the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionOct 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anne Roivainen, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878721
- Sponsor's protocol ID
- 14824
- Acronym
- PETU
- Status last verified
- Oct 2021
- First submitted
- 10 Jun 2013
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography of Infection and Vasculitis (PETU)
- ClinicalTrials.gov ID
- NCT01878721
- Acronym / sponsor ID
- PETU / 14824
- Conditions
- Infection, Vasculitis
- Keywords
- PET/CT, infection, vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Jan 2011
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Staphylococcus aureus bacteremia | – | Radiation: PET/CTPET/CT in patients with Staphylococcus aureus bacteremia |
| Salmonella spp. bacteremia | – | Radiation: PET/CTPET/CT in patients with Salmonella spp. bacteremia |
| Endocarditis | – | Radiation: PET/CTPET/CT in patients with infective endocarditis |
| Pacemaker infection | – | Radiation: PET/CTPET/CT in patients with pacemaker infection |
| Vasculitis | – | Radiation: PET/CTPET/CT in patients with vasculitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Turku University Hospital
Key inclusion criteria (6 listed)
- Adults with
- Staphylococcus aureus bacteremia or
- Salmonella spp. bacteremia or
- infective endocarditis or
- infection of pacemaker or implantable cardioverter defibrillator or
Key exclusion criteria (1 listed)
- underage, pregnant, breastfeeding, handicapped or prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CTpositron emission tomography/computed tomography | Radiation | Endocarditis, Pacemaker infection, Salmonella spp. bacteremia, Staphylococcus aureus bacteremia, Vasculitis |
Primary outcome
Detection of infection or vasculitis in PET images
Time frame: within 1 week after starting the treatment
1 secondary outcome
Standardized uptake value of PET imaging agent at the site of infection or vasculitis
Time frame: within 1 week after starting the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Vasculitis, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of infection or vasculitis in PET images (time frame: within 1 week after starting the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.