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Cliavist in Infectious and Degenerative Diseases of the Spine


Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification Date
Recruiting Spine Infection University Hospital, Strasbourg, France Other September 4, 2006 February 24, 2009 February 2009

Study TypeStudy DesignPhaseEnrollmentStart DateEnd Date
Interventional Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic Phase 3 40 March 2007 -

Locations

FacilityAddressContactPhoneEmailStatus
Service de Neuroradiologie - Hôpital Central Nancy 54035 France Serge Bracard, MD - s.bracard@chu-nancy.fr Not yet recruiting
Service de Radiologie 2 - Hôpital de Hautepierre Strasbourg 67098 France Jean-louis Dietemann, MD - jean-louis.dietemann@chru-strasbourg.fr Recruiting
Service de Rhumatologie - Hôpital de Hautepierre Strasbourg 67098 France Jean Sibilia, MD - jean.sibilia@chru-strasbourg.fr Not yet recruiting
Nouvel Hôpital Civil Strasbourg 67091 France Guillaume BIERRY, MD - guillaume.bierry@chru-strasbourg.fr Not yet recruiting

Intervention

TypeInterventionDescription
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

TypeMeasureTime FrameSafety Issue
Primary First MRI: performed immediately after gadolinium administration immediately after gadolinium administration No
Primary Second MRI: performed 24 hours after cliavist administration 24 hours after cliavist administration No

Official Title

Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine

Eligibility

GenderMinimum AgeMaximum AgeHealthy Volunteers
Both - N/A No

Inclusion Criteria:

- spine infection or spine degenerative disease

- patient agreement obtained

Exclusion Criteria:

- pregnancy

- MRI contra-indications

- cliavist contra-indication

- dextran allergy