Cliavist in Infectious and Degenerative Diseases of the Spine
Cliavist in Infectious and Degenerative Diseases of the Spine
This study is currently recruiting patients.
Verified by University of Strasbourg March 2007
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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 III |
MedlinePlus consumer health information
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 of Strasbourg:
Primary Outcome Measures:
Total Enrollment: 40
- First MRI: performed immediately after gadolinium administration
- Second MRI: performed 24 hours after cliavist administration
Total Enrollment: 40
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- spine infection or spine degenerative disease
- patient agreement obtained
Exclusion Criteria:
- pregnancy
- MRI contra-indications
- cliavist contra-indication
- dextran allergy
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00372281
Jean-Louis Dietemann, MD jean-louis.dietemann@chru-strasbourg.fr
Stéphane Kremer, MD stephane.kremer@chru-strasbourg.fr
Stéphane Kremer, MD stephane.kremer@chru-strasbourg.fr
France
Service de Radiologie 2 - Hôpital de Hautepierre, Strasbourg, 67098, France; Recruiting
Jean-louis Dietemann, MD jean-louis.dietemann@chru-strasbourg.fr
Stephane Kremer, MD stephane.kremer@chru-strasbourg.fr
Jean-Louis Dietemann, MD, Sub-Investigator
Stéphane Kremer, MD, Principal Investigator
Stephane Kremer, MD stephane.kremer@chru-strasbourg.fr
Jean-Louis Dietemann, MD, Sub-Investigator
Stéphane Kremer, MD, Principal Investigator
Service de Rhumatologie - Hôpital de Hautepierre, Strasbourg, 67098, France; Not yet recruiting
Jean Sibilia, MD jean.sibilia@chru-strasbourg.fr
Jean Sibilia, MD, Principal Investigator
Jean Sibilia, MD, Principal Investigator
Service de Radiologie B - Hôpital Jean Minjoz, Besançon, 25030, France; Not yet recruiting
Jean-François Bonneville, MD jean-françois.bonneville@ufc-chu.univ-fcomte.fr
Michel Runge, MD michel.runge@ufc-chu.univ-fcomte.fr
Jean-François Bonneville, MD, Principal Investigator
Michel Runge, MD, Sub-Investigator
Michel Runge, MD michel.runge@ufc-chu.univ-fcomte.fr
Jean-François Bonneville, MD, Principal Investigator
Michel Runge, MD, Sub-Investigator
Service de Neuroradiologie - Hôpital Central, Nancy, 54035, France; Not yet recruiting
Serge Bracard, MD s.bracard@chu-nancy.fr
Emmanuelle Schmitt, MD e.schmitt@chu-nancy.fr
Serge Bracard, MD, Principal Investigator
Emmanuelle Schmitt, MD, Sub-Investigator
Emmanuelle Schmitt, MD e.schmitt@chu-nancy.fr
Serge Bracard, MD, Principal Investigator
Emmanuelle Schmitt, MD, Sub-Investigator
Study chairs or principal investigators
Jean-Louis Dietemann, MD, Study Director, Hôpitaux Universitaires de Strasbourg
More Information
Study ID Numbers: 3780
Last Updated: March 8, 2007
Record first received: September 4, 2006
ClinicalTrials.gov Identifier: NCT00372281
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on June 12, 2007
Last Updated: March 8, 2007
Record first received: September 4, 2006
ClinicalTrials.gov Identifier: NCT00372281
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on June 12, 2007
Updated on: 01/12/10
