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
Recruitment status was Recruiting
Sponsor:
University Hospital, Strasbourg, France
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
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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
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 | |
| 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 | |
| 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: | 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 |
ClinicalTrials.gov processed this record on May 22, 2013