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Cliavist in Infectious and Degenerative Diseases of the Spine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Information provided by:
University Hospital, Strasbourg, France Identifier:
First received: September 4, 2006
Last updated: February 24, 2009
Last verified: February 2009
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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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 ]
  • Second MRI: performed 24 hours after cliavist administration [ Time Frame: 24 hours after cliavist administration ]

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
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.


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
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Please refer to this study by its identifier: NCT00372281

Contact: Jean-Louis Dietemann, MD (33) 3 88127888
Contact: Stéphane Kremer, MD (33) 3 88127888

Service de Neuroradiologie - Hôpital Central Not yet recruiting
Nancy, France, 54035
Contact: Serge Bracard, MD   
Contact: Emmanuelle Schmitt, MD   
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   
Principal Investigator: Guillaume BIERRY, MD         
Service de Radiologie 2 - Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Jean-louis Dietemann, MD   
Contact: Stephane Kremer, MD   
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   
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 Identifier: NCT00372281     History of Changes
Other Study ID Numbers: 3780
Study First Received: September 4, 2006
Last Updated: February 24, 2009

Keywords provided by University Hospital, Strasbourg, France:
MRI, CLIAVIST, MACROPHAGE, INFECTION, SPINE processed this record on April 28, 2017