NCT01542853

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

First QC Date

February 27, 2012

Last Update Submit

February 15, 2013

Conditions

Spondylodiscitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

10 patients with MRI or PET/CT findings as well as overall clinical assessment compatible with spondylodiscitis.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

department of nuclear medicine, Odense University Hospital

Odense, 5000, Denmark

Location

Department of radiology, Odense University Hospital

Odense, 5000, Denmark

Location

Department of infectious diseases, Odense University Hospital

Odense C, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Discitis

Condition Hierarchy (Ancestors)

SpondylitisBone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal DiseasesSpinal Diseases

Study Officials

  • Court Pedersen, MD, DMSc

    department of infectious diseases, Odense University Hospital

    STUDY CHAIR

  • michala Kehrer, MD

    Department of infectious diseases, Odense University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 2, 2012

Study Start

March 1, 2012

Study Completion

March 1, 2013

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

DK(3)