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

Spondylodiscitis Clinical Trial

Official title:

Preliminary Study. The Value of 18F-FDG PET/CT Compared to MRI in Diagnosing Residual Disease in Patients With Spondylodiscitis

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01542853
• Other study ID #: spondylodiscitis-pilot
• Status: Suspended
• Phase: N/A
• First received: February 27, 2012
• Last updated: February 15, 2013
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: February 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Discitis
• Spondylodiscitis

Locations

Country	Name	City	State
Denmark	department of nuclear medicine, Odense University Hospital	Odense
Denmark	Department of radiology, Odense University Hospital	Odense
Denmark	Department of infectious diseases, Odense University Hospital	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark,