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

Suspended

• Conditions: Spondylodiscitis

• Registration Number: NCT01542853
• Lead Sponsor: Odense University Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2012-02-27
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-15
• Last Update Posted: 2013-02-18
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Department of infectious diseases, Odense University Hospital; 🇩🇰 Odense C, Denmark

Department of radiology, Odense University Hospital; 🇩🇰 Odense, Denmark

department of nuclear medicine, Odense University Hospital; 🇩🇰 Odense, Denmark