Cliavist in Infectious and Degenerative Diseases of the Spine

Cliavist in Infectious and Degenerative Diseases of the Spine

This study is currently recruiting patients.
Verified by University of Strasbourg March 2007

Sponsored by: University of Strasbourg
Information provided by: University of Strasbourg
ClinicalTrials.gov Identifier: NCT00372281

clinical trials Purpose

USPIO contrast enhancement results from intracellular trapping of the iron particles in reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages are present in spine infectious diseases but are absent in spine degenerative diseases. The aim of this work is to compare the enhancement induced by CLIAVIST in both diseases. The absence of macrophages in degenerative lesions should help to differentiate them from infectious lesions, who should present contrast enhancement in relation to the presence of macrophages.
Condition Intervention Phase
Spine Infection
  Drug: Cliavist
 Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title: Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine

Further study details as provided by University of Strasbourg:
Primary Outcome Measures: 
  • First MRI: performed immediately after gadolinium administration
  • Second MRI: performed 24 hours after cliavist administration

Total Enrollment:  40

clinical trials Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • spine infection or spine degenerative disease
  • patient agreement obtained

Exclusion Criteria:

  • pregnancy
  • MRI contra-indications
  • cliavist contra-indication
  • dextran allergy

clinical trials Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00372281

Jean-Louis Dietemann, MD       jean-louis.dietemann@chru-strasbourg.fr
Stéphane Kremer, MD       stephane.kremer@chru-strasbourg.fr

France
      Service de Radiologie 2 - Hôpital de Hautepierre, Strasbourg,  67098,  France; Recruiting
Jean-louis Dietemann, MD   jean-louis.dietemann@chru-strasbourg.fr 
Stephane Kremer, MD   stephane.kremer@chru-strasbourg.fr 
Jean-Louis Dietemann, MD,  Sub-Investigator
Stéphane Kremer, MD,  Principal Investigator

      Service de Rhumatologie - Hôpital de Hautepierre, Strasbourg,  67098,  France; Not yet recruiting
Jean Sibilia, MD   jean.sibilia@chru-strasbourg.fr 
Jean Sibilia, MD,  Principal Investigator

      Service de Radiologie B - Hôpital Jean Minjoz, Besançon,  25030,  France; Not yet recruiting
Jean-François Bonneville, MD   jean-françois.bonneville@ufc-chu.univ-fcomte.fr 
Michel Runge, MD   michel.runge@ufc-chu.univ-fcomte.fr 
Jean-François Bonneville, MD,  Principal Investigator
Michel Runge, MD,  Sub-Investigator

      Service de Neuroradiologie - Hôpital Central, Nancy,  54035,  France; Not yet recruiting
Serge Bracard, MD   s.bracard@chu-nancy.fr 
Emmanuelle Schmitt, MD   e.schmitt@chu-nancy.fr 
Serge Bracard, MD,  Principal Investigator
Emmanuelle Schmitt, MD,  Sub-Investigator

Study chairs or principal investigators


Jean-Louis Dietemann, MD,  Study Director,  Hôpitaux Universitaires de Strasbourg   

clinical trials More Information

Study ID Numbers:  3780
Last Updated:  March 8, 2007
Record first received:  September 4, 2006
ClinicalTrials.gov Identifier:  NCT00372281
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on June 12, 2007
Last Updated: 06/13/2007
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