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
  Purpose

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
Spondylodiscitis

Study Type: Observational
Study Design: 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

Further study details as provided by Odense University Hospital:

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542853

Locations
Denmark
department of nuclear medicine, Odense University Hospital
Odense, Denmark, 5000
Department of radiology, Odense University Hospital
Odense, Denmark, 5000
Department of infectious diseases, Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Michala Kehrer, MD, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01542853     History of Changes
Other Study ID Numbers: spondylodiscitis-pilot
Study First Received: February 27, 2012
Last Updated: February 15, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Discitis
Spondylitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014