SpondylodiscitisNCT01542853
The Value of PET/CT in Diagnosing Residual Disease in Patients With Spinal Infection
An observational study of Spondylodiscitis, run by Odense University Hospital at 3 sites in Denmark.
Trial summary
MRI has shoved little correlation with the clinical finding during treatment of spondylodiscitis (infection in the vertebrae and/or discs). Since PET/CT is almost as good as MRI in diagnosing spondylodiscitis the hypothesis and this study is that PET/CT is better in predicting residual disease in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylodiscitis
- How many people
- 10 participants
- Where
- 3 sitesDenmark
- Study dates
- Mar 2012to Mar 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: 10 patients with MRI or PET/CT findings as well as overall clinical assessment compatible with spondylodiscitis.
Who may be able to join
- first case of infectious spondylodiscitis
- MRI or 18-F-FDG PET/CT compatible with spondylodiscitis
- overall assessment compatible with spondylodiscitis
Who cannot join
- previous spinal infection (e.g. spondylodiscitis; epidural abscess)
- spinal operation in the previous 6 months
- spinal foreign body
- current malignant disease
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
department of nuclear medicine, Odense University Hospital
Odense, 5000
Department of radiology, Odense University Hospital
Odense, 5000
Department of infectious diseases, Odense University Hospital
Odense C, 5000
About this study
Official title: Preliminary Study. The Value of 18F-FDG PET/CT Compared to MRI in Diagnosing Residual Disease in Patients With Spondylodiscitis
MRI has shoved little correlation with the clinical finding during treatment of spondylodiscitis (infection in the vertebrae and/or discs). Since PET/CT is almost as good as MRI in diagnosing spondylodiscitis the hypothesis and this study is that PET/CT is better in predicting residual disease in patients with spondylodiscitis.
Preliminary study.
Read the detailed description
In the last years there has been reported increasing incidence of spondylodiscitis. The increase is mainly thought to be caused by the increasing elderly population and the increasing amount of spinal instrumentation in this population. The symptoms range from backache to severe neurological deficits. Up to 1/3 of cases are reported to be culture negative and cases can therefore be difficult to diagnose.
MRI is thought to be the main imaging technique to visualise infection. But with the increasing availability of 18-F FDG PET/CT, it is reported to be nearly as efficient to diagnose spinal infection.
During the long antibiotic treatment of spondylodiscitis, the clinicians have no real good imaging technique to predict residual disease since MRI during the remodelling fase of the spine will mimic no difference or worsening.
Since 18-F-FDG PET marks areas with a high amount of inflammatory cells it may also be faster in returning to normal images and therefore correlates better to actual status than MRI.
Some of the purposes of this study are therefore:
- To describe changes on PET/CT and MRI at index and after 4, 8 12 and 26 weeks and compare these to the clinical findings as well as inflammatory biomarkers.
- To investigate the correlation between normalisation of inflammatory biomarkers and changes on MRI and PET/CT.
- Conditions
- Spondylodiscitis
- Medical subject headings
- Discitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2012
- Study completionMar 2013 (estimated)
Why it stopped: problems with recruitment and funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylodiscitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michala Kehrer, MD, Odense University Hospital
- Investigators
- Court Pedersen, MD, DMSc, Study chair, department of infectious diseases, Odense University Hospitalmichala Kehrer, MD, Principal investigator, Department of infectious diseases, Odense University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542853
- Sponsor's protocol ID
- spondylodiscitis-pilot
- Status last verified
- Feb 2013
- First submitted
- 27 Feb 2012
- Last updated
- 18 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study. The Value of 18F-FDG PET/CT Compared to MRI in Diagnosing Residual Disease in Patients With Spondylodiscitis
- ClinicalTrials.gov ID
- NCT01542853
- Acronym / sponsor ID
- spondylodiscitis-pilot
- Conditions
- Spondylodiscitis
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: problems with recruitment and funding
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Study completion
- Mar 2013 (estimated)
- First posted
- 2 Mar 2012 (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.
MRI has shoved little correlation with the clinical finding during treatment of spondylodiscitis (infection in the vertebrae and/or discs). Since PET/CT is almost as good as MRI in diagnosing spondylodiscitis the hypothesis and this study is that PET/CT is better in predicting residual disease in patients with spondylodiscitis.
Preliminary study.
Detailed description
In the last years there has been reported increasing incidence of spondylodiscitis. The increase is mainly thought to be caused by the increasing elderly population and the increasing amount of spinal instrumentation in this population. The symptoms range from backache to severe neurological deficits. Up to 1/3 of cases are reported to be culture negative and cases can therefore be difficult to diagnose.
MRI is thought to be the main imaging technique to visualise infection. But with the increasing availability of 18-F FDG PET/CT, it is reported to be nearly as efficient to diagnose spinal infection.
During the long antibiotic treatment of spondylodiscitis, the clinicians have no real good imaging technique to predict residual disease since MRI during the remodelling fase of the spine will mimic no difference or worsening.
Since 18-F-FDG PET marks areas with a high amount of inflammatory cells it may also be faster in returning to normal images and therefore correlates better to actual status than MRI.
Some of the purposes of this study are therefore:
- To describe changes on PET/CT and MRI at index and after 4, 8 12 and 26 weeks and compare these to the clinical findings as well as inflammatory biomarkers.
- To investigate the correlation between normalisation of inflammatory biomarkers and changes on MRI and PET/CT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients with MRI or PET/CT findings as well as overall clinical assessment compatible with spondylodiscitis.
Key inclusion criteria (3 listed)
- first case of infectious spondylodiscitis
- MRI or 18-F-FDG PET/CT compatible with spondylodiscitis
- overall assessment compatible with spondylodiscitis
Key exclusion criteria (4 listed)
- previous spinal infection (e.g. spondylodiscitis; epidural abscess)
- spinal operation in the previous 6 months
- spinal foreign body
- current malignant disease
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
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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.
Court Pedersen, MD, DMSc study chair
department of infectious diseases, Odense University Hospital
michala Kehrer, MD principal investigator
Department of infectious diseases, Odense University Hospital, Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylodiscitis, run by Odense University Hospital at 3 sites 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 3 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: paused, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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.
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 18 Feb 2013.