The Value of PET/CT in Diagnosing Residual Disease in Patients With Spinal Infection
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|ClinicalTrials.gov Identifier: NCT01542853|
Recruitment Status : Suspended (problems with recruitment and funding)
First Posted : March 2, 2012
Last Update Posted : February 18, 2013
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.
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Preliminary Study. The Value of 18F-FDG PET/CT Compared to MRI in Diagnosing Residual Disease in Patients With Spondylodiscitis|
|Study Start Date :||March 2012|
|Estimated Study Completion Date :||March 2013|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542853
|Department of infectious diseases, Odense University Hospital|
|Odense C, Denmark, 5000|
|department of nuclear medicine, Odense University Hospital|
|Odense, Denmark, 5000|
|Department of radiology, Odense University Hospital|
|Odense, Denmark, 5000|
|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|