Bacterial InfectionsPIN-UPNCT00835783
Validation Study of Combined Positron Emission Tomography/Computer Tomography to Diagnose Infection and Inflammation
An observational study of Bacterial Infections and Bacteremia, run by Odense University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections, Bacteremia, Gram-Positive Bacterial Infections
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2008to Dec 2013
- 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 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Odense University Hospital, Dept. of Nuclear Medicine
Odense, 5000
About this study
Official title: PET/CT in Infection and Inflammation Imaging: Current Utility and Future Perspectives (The PIN-UP Study)
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".
Read the 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).
- Medical subject headings
- Bacterial Infections, Bacteremia, Gram-Positive Bacterial Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy.
Measured: During diagnostic workup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Study logistics proved difficult and enrollment never moved beyond the pilot phase.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Odense 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Søren Hess, MD, Odense University Hospital
- Investigators
- Søren Hess, MD, Principal investigator, Odense University Hospital, Dept. of Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835783
- Sponsor's protocol ID
- 105-K20
- Acronym
- PIN-UP
- Status last verified
- Oct 2014
- First submitted
- 3 Feb 2009
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT in Infection and Inflammation Imaging: Current Utility and Future Perspectives (The PIN-UP Study)
- ClinicalTrials.gov ID
- NCT00835783
- Acronym / sponsor ID
- PIN-UP / 105-K20
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study logistics proved difficult and enrollment never moved beyond the pilot phase.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Feb 2009 (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 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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy
Time frame: During diagnostic workup
Diagnostic parameters of FDG-PET/CT (ie. sensitivity, specificity, positive and negative predictive values, accuracy.
Results and safety
The study was stopped early (reason given: Study logistics proved difficult and enrollment never moved beyond the pilot phase.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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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.
Søren Hess, MD principal investigator
Odense University Hospital, Dept. of Nuclear Medicine
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 Bacterial Infections and Bacteremia, run by Odense University Hospital at 1 site in Denmark.
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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 28 Oct 2014. 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 Denmark. 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 was stopped early (reason given: Study logistics proved difficult and enrollment never moved beyond the pilot phase.). Results are not available in the source record.
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?
Efficacy (time frame: During diagnostic workup). 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 28 Oct 2014.