Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- First MRI: performed immediately after gadolinium administration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Cliavist
Intervention: Cliavist (Drug)
Outcomes
Primary Outcomes
First MRI: performed immediately after gadolinium administration
Time Frame: immediately after gadolinium administration
Second MRI: performed 24 hours after cliavist administration
Time Frame: 24 hours after cliavist administration
Secondary Outcomes
No secondary outcomes reported