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SuspendedNCT01542853Updated Feb 18, 2013

The Value of PET/CT in Diagnosing Residual Disease in Patients With Spinal Infection

An observational study in Spondylodiscitis, sponsored by Odense University Hospital. Suspended at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-18.

Sponsored by Odense University Hospital · Observational

Why this study was suspended
problems with recruitment and funding
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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 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.
02

Conditions studied

  • Spondylodiscitis

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03

In context

Discitis

24 studies on the registry are indexed under Discitis; 5 are open to participants now.

This study's planned enrollment of 10 is below the median of 104 across 16 observational studies indexed under Discitis.

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Lead sponsor

Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

10 patients with MRI or PET/CT findings as well as overall clinical assessment compatible with spondylodiscitis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • first case of infectious spondylodiscitis
  • MRI or 18-F-FDG PET/CT compatible with spondylodiscitis
  • overall assessment compatible with spondylodiscitis

Exclusion criteria

Exclusion Criteria:

  • previous spinal infection (e.g. spondylodiscitis; epidural abscess)
  • spinal operation in the previous 6 months
  • spinal foreign body
  • current malignant disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Biospecimen retention
Samples with dna
06

Study locations

3 sites
  • Department of infectious diseases, Odense University Hospital
    Odense C, 5000, Denmark
  • department of nuclear medicine, Odense University Hospital
    Odense, 5000, Denmark
  • Department of radiology, Odense University Hospital
    Odense, 5000, Denmark
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2012 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2012
First posted
Mar 2, 2012
Start
Mar 2012
CompletionEst.
Mar 2013
Last update
Feb 18, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01542853
Responsible party
Michala Kehrer, MD (MD, Odense University Hospital) — Principal investigator
First posted
Mar 2, 2012
Start date
Mar 2012
Completion
Mar 2013 (estimated)
Last update
Feb 18, 2013

Study contacts

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
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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