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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01542853
Recruitment Status : Suspended (problems with recruitment and funding)
First Posted : March 2, 2012
Last Update Posted : February 18, 2013
Information provided by (Responsible Party):
Michala Kehrer, MD, 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.

Condition or disease

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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Biospecimen Retention:   Samples With DNA
whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01542853

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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
Sponsors and Collaborators
Odense University Hospital
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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
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Responsible Party: Michala Kehrer, MD, MD, Odense University Hospital Identifier: NCT01542853    
Other Study ID Numbers: spondylodiscitis-pilot
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases