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Cliavist in Infectious and Degenerative Diseases of the Spine

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00372281
Enrollment
40
Registered
2006-09-06
Start date
2007-03-31
Completion date
2009-12-31
Last updated
2009-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine Infection

Keywords

MRI, CLIAVIST, MACROPHAGE, INFECTION, 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.

Interventions

DRUGCliavist

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.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* spine infection or spine degenerative disease * patient agreement obtained

Exclusion criteria

* pregnancy * MRI contra-indications * cliavist contra-indication * dextran allergy

Design outcomes

Primary

MeasureTime frame
First MRI: performed immediately after gadolinium administrationimmediately after gadolinium administration
Second MRI: performed 24 hours after cliavist administration24 hours after cliavist administration

Countries

France

Contacts

Primary ContactJean-Louis Dietemann, MD
jean-louis.dietemann@chru-strasbourg.fr(33) 3 88127888
Backup ContactStéphane Kremer, MD
stephane.kremer@chru-strasbourg.fr(33) 3 88127888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026