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

This study has suspended participant recruitment.
(problems with recruitment and funding)
Sponsor:
Information provided by (Responsible Party):
Michala Kehrer, MD, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01542853
First received: February 27, 2012
Last updated: February 15, 2013
Last verified: February 2013

February 27, 2012
February 15, 2013
March 2012
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Complete list of historical versions of study NCT01542853 on ClinicalTrials.gov Archive Site
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The Value of PET/CT in Diagnosing Residual Disease in Patients With Spinal Infection
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

whole blood

Probability Sample

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

Spondylodiscitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
10
March 2013
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Inclusion Criteria:

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

Exclusion Criteria:

  • previous spinal infection (e.g. spondylodiscitis; epidural abscess)
  • spinal operation in the previous 6 months
  • spinal foreign body
  • current malignant disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01542853
spondylodiscitis-pilot
Not Provided
Michala Kehrer, MD, Odense University Hospital
Odense University Hospital
Not Provided
Study Chair: Court Pedersen, MD, DMSc department of infectious diseases, Odense University Hospital
Principal Investigator: michala Kehrer, MD Department of infectious diseases, Odense University Hospital, Denmark
Odense University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP