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