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Cliavist in Infectious and Degenerative Diseases of the Spine

This study is currently recruiting participants.
Verified by University Hospital, Strasbourg, France, March 2007

Sponsored by: University Hospital, Strasbourg, France
Information provided by: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00372281
  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

U.S. FDA Resources

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 Hospital, Strasbourg, France:

Primary Outcome Measures:
  • First MRI: performed immediately after gadolinium administration
  • Second MRI: performed 24 hours after cliavist administration

Estimated Enrollment:   40

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • spine infection or spine degenerative disease
  • patient agreement obtained

Exclusion Criteria:

  • pregnancy
  • MRI contra-indications
  • cliavist contra-indication
  • dextran allergy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372281

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

Locations
France
Service de Radiologie 2 - Hôpital de Hautepierre     Recruiting
      Strasbourg, France, 67098
      Contact: Jean-louis Dietemann, MD         jean-louis.dietemann@chru-strasbourg.fr    
      Contact: Stephane Kremer, MD         stephane.kremer@chru-strasbourg.fr    
      Sub-Investigator: Jean-Louis Dietemann, MD            
      Principal Investigator: Stéphane Kremer, MD            
Service de Rhumatologie - Hôpital de Hautepierre     Not yet recruiting
      Strasbourg, France, 67098
      Contact: Jean Sibilia, MD         jean.sibilia@chru-strasbourg.fr    
      Principal Investigator: Jean Sibilia, MD            
Service de Radiologie B - Hôpital Jean Minjoz     Not yet recruiting
      Besançon, France, 25030
      Contact: Jean-François Bonneville, MD         jean-françois.bonneville@ufc-chu.univ-fcomte.fr    
      Contact: Michel Runge, MD         michel.runge@ufc-chu.univ-fcomte.fr    
      Principal Investigator: Jean-François Bonneville, MD            
      Sub-Investigator: Michel Runge, MD            
Service de Neuroradiologie - Hôpital Central     Not yet recruiting
      Nancy, France, 54035
      Contact: Serge Bracard, MD         s.bracard@chu-nancy.fr    
      Contact: Emmanuelle Schmitt, MD         e.schmitt@chu-nancy.fr    
      Principal Investigator: Serge Bracard, MD            
      Sub-Investigator: Emmanuelle Schmitt, MD            

Sponsors and Collaborators
University Hospital, Strasbourg, France

Investigators
Study Director:     Jean-Louis Dietemann, MD     Hôpitaux Universitaires de Strasbourg    
  More Information

Study ID Numbers:   3780
First Received:   September 4, 2006
Last Updated:   March 8, 2007
ClinicalTrials.gov Identifier:   NCT00372281
Health Authority:   France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
MRI, CLIAVIST, MACROPHAGE, INFECTION, SPINE  

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on July 18, 2008




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