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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 4, 2006 | ||||||||
| Last Updated Date | February 24, 2009 | ||||||||
| Start Date ICMJE | March 2007 | ||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00372281 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cliavist in Infectious and Degenerative Diseases of the Spine | ||||||||
| Official Title ICMJE | 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 | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Spine Infection | ||||||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: Cliavist
Intervention: Drug: Cliavist |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00372281 | ||||||||
| Other Study ID Numbers ICMJE | 3780 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg | ||||||||
| Study Sponsor ICMJE | University Hospital, Strasbourg, France | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Strasbourg, France | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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