Cliavist in Infectious and Degenerative Diseases of the Spine

NCT ID: NCT00372281

Last Updated: 2009-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spine Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cliavist

Group Type EXPERIMENTAL

Cliavist

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* spine infection or spine degenerative disease
* patient agreement obtained

Exclusion Criteria

* pregnancy
* MRI contra-indications
* cliavist contra-indication
* dextran allergy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg

Principal Investigators

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Jean-Louis Dietemann, MD

Role: STUDY_DIRECTOR

Hôpitaux Universitaires de Strasbourg

Locations

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Service de Neuroradiologie - Hôpital Central

Nancy, , France

Site Status NOT_YET_RECRUITING

Nouvel Hôpital Civil

Strasbourg, , France

Site Status NOT_YET_RECRUITING

Service de Radiologie 2 - Hôpital de Hautepierre

Strasbourg, , France

Site Status RECRUITING

Service de Rhumatologie - Hôpital de Hautepierre

Strasbourg, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Jean-Louis Dietemann, MD

Role: CONTACT

(33) 3 88127888

Stéphane Kremer, MD

Role: CONTACT

(33) 3 88127888

Facility Contacts

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Serge Bracard, MD

Role: primary

Emmanuelle Schmitt, MD

Role: backup

Guillaume BIERRY, MD

Role: primary

33 (3) 88116280

Jean-louis Dietemann, MD

Role: primary

Stephane Kremer, MD

Role: backup

Jean Sibilia, MD

Role: primary

Other Identifiers

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3780

Identifier Type: -

Identifier Source: org_study_id

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