The Value of PET/CT in Diagnosing Residual Disease in Pat... | NCT01542853

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

NCT01542853

Sponsor

Odense University Hospital

Status

Suspended

Last Update Posted

Feb 18, 2013Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Spondylodiscitis

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

problems with recruitment and funding

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Not provided

Completion Date

Mar 2013Estimated

First Submitted Date

Feb 27, 2012

First Submission Date that Met QC Criteria

Mar 1, 2012

First Posted Date

Mar 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2013

Last Update Posted Date

Feb 18, 2013Estimated

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
department of nuclear medicine, Odense University Hospital		Odense		5000	Denmark
Department of radiology, Odense University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D015299	Discitis

Ancestor Terms

ID	Term
D013166	Spondylitis
D001850	Bone Diseases, Infectious
D007239	Infections
D001847	Bone Diseases

Browse Leaves

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Browse Branches

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