Cliavist in Infectious and Degenerative Diseases of the Spine

Trial Overview

Status	Condition	Sponsor/Collaborator(s)	First Received	Last Changed	Verification Date
Recruiting	Spine Infection	University Hospital, Strasbourg, France Other	September 4, 2006	February 24, 2009	February 2009

Study Type	Study Design	Phase	Enrollment	Start Date	End 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	-

Facility	Address	Contact	Phone	Email	Status
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

Type	Intervention	Description
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.

Type	Measure	Time Frame	Safety 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

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

Gender	Minimum Age	Maximum Age	Healthy 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