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Cliavist in Infectious and Degenerative Diseases of the Spine

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ClinicalTrials.gov Identifier: NCT00372281
Recruitment Status : Unknown
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : September 6, 2006
Last Update Posted : February 25, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Spine Infection Drug: Cliavist Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine
Study Start Date : March 2007
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: Cliavist 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.

Outcome Measures

Primary Outcome Measures :
  1. First MRI: performed immediately after gadolinium administration [ Time Frame: immediately after gadolinium administration ]
  2. Second MRI: performed 24 hours after cliavist administration [ Time Frame: 24 hours after cliavist administration ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372281

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

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         
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         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Study Director: Jean-Louis Dietemann, MD Hôpitaux Universitaires de Strasbourg
More Information

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00372281     History of Changes
Other Study ID Numbers: 3780
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: February 25, 2009
Last Verified: February 2009

Keywords provided by University Hospital, Strasbourg, France: