Cliavist in Infectious and Degenerative Diseases of the Spine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00372281
First received: September 4, 2006
Last updated: February 24, 2009
Last verified: February 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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 ] [ 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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: September 4, 2006
Last Updated: February 24, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on October 29, 2014