Cliavist in Infectious and Degenerative Diseases of the Spine

University Hospital, Strasbourg, France

Status and phase: Unknown; Phase 3

Conditions: Spine Infection

Treatments: Drug: Cliavist

Study type: Interventional

Funder types: Other

Identifiers

NCT00372281

3780

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• spine infection or spine degenerative disease
• patient agreement obtained

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Cliavist

Experimental group

Treatment:

Drug: Cliavist