Full Text View
Tabular View
No Study Results Posted
Related Studies
Cliavist in Infectious and Degenerative Diseases of the Spine
This study is currently recruiting participants.
Verified by University Hospital, Strasbourg, France, February 2009
First Received: September 4, 2006   Last Updated: February 24, 2009   History of Changes
Sponsor: 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

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 [ Time Frame: immediately after gadolinium administration ] [ Designated as safety issue: No ]
  • Second MRI: performed 24 hours after cliavist administration [ Time Frame: 24 hours after cliavist administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cliavist: Experimental Drug: Cliavist
Injection of 0,9 mL (weight < 60kg) or 1,4 mL (weight > 60kg) of Cliavist (ferucarbotran) by direct intraveinous way, 48 h following the MRI done with gadolinium.

  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 (33) 3 88127888 jean-louis.dietemann@chru-strasbourg.fr
Contact: Stéphane Kremer, MD (33) 3 88127888 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 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            
Nouvel Hôpital Civil Not yet recruiting
Strasbourg, France, 67091
Contact: Guillaume BIERRY, MD     33 (3) 88116280     guillaume.bierry@chru-strasbourg.fr    
Principal Investigator: Guillaume BIERRY, MD            
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Jean-Louis Dietemann, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg ( Christine GEILLER )
Study ID Numbers: 3780
Study First Received: September 4, 2006
Last Updated: February 24, 2009
ClinicalTrials.gov Identifier: NCT00372281     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

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

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on February 08, 2010