Cliavist in Infectious and Degenerative Diseases of the Spine

Spine Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00372281
• Other study ID #: 3780
• Status: Recruiting
• Phase: Phase 3
• First received: September 4, 2006
• Last updated: February 24, 2009
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: University Hospital, Strasbourg, France
• Contact: Jean-Louis Dietemann, MD
• Phone: (33) 3 88127888
• Email: jean-louis.dietemann[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• spine infection or spine degenerative disease

• patient agreement obtained

Exclusion Criteria:

• pregnancy

• MRI contra-indications

• cliavist contra-indication

• dextran allergy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Spine Infection

Intervention

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.

Locations

Country	Name	City	State
France	Service de Neuroradiologie - Hôpital Central	Nancy
France	Nouvel Hôpital Civil	Strasbourg
France	Service de Radiologie 2 - Hôpital de Hautepierre	Strasbourg
France	Service de Rhumatologie - Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	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