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| Descriptive Information Fields | |||||||||
| Brief Title † | Cliavist in Infectious and Degenerative Diseases of the Spine | ||||||||
| Official Title † | Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine | ||||||||
| Brief 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | First MRI: performed immediately after gadolinium administration Second MRI: performed 24 hours after cliavist administration |
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| Secondary Outcome Measure † | |||||||||
| Condition † | Spine Infection | ||||||||
| Intervention † | Drug: Cliavist | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 40 | ||||||||
| Start Date † | |||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | France | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00372281 | ||||||||
| Organization ID | 3780 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University Hospital, Strasbourg, France | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University Hospital, Strasbourg, France | ||||||||
| Verification Date | March 2007 | ||||||||
| First Received Date † | September 4, 2006 | ||||||||
| Last Updated Date | March 8, 2007 | ||||||||
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