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Cliavist in Infectious and Degenerative Diseases of the Spine

Primary Purpose

Spine Infection

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Cliavist

About this trial

This is an interventional diagnostic trial for Spine Infection focused on measuring MRI, CLIAVIST, MACROPHAGE, INFECTION, SPINE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

spine infection or spine degenerative disease
patient agreement obtained

Exclusion Criteria:

pregnancy
MRI contra-indications
cliavist contra-indication
dextran allergy

Sites / Locations

Service de Neuroradiologie - Hôpital Central
Nouvel Hôpital Civil
Service de Radiologie 2 - Hôpital de HautepierreRecruiting
Service de Rhumatologie - Hôpital de Hautepierre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cliavist

Arm Description

Outcomes

Primary Outcome Measures

First MRI: performed immediately after gadolinium administration

Second MRI: performed 24 hours after cliavist administration

Secondary Outcome Measures

Full Information

NCT ID

NCT00372281

First Posted

September 4, 2006

Last Updated

February 24, 2009

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT00372281

Brief Title

Cliavist in Infectious and Degenerative Diseases of the Spine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spine Infection

Keywords

MRI, CLIAVIST, MACROPHAGE, INFECTION, SPINE

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cliavist

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cliavist

Intervention Description

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.

Primary Outcome Measure Information:

Title

First MRI: performed immediately after gadolinium administration

Time Frame

immediately after gadolinium administration

Title

Second MRI: performed 24 hours after cliavist administration

Time Frame

24 hours after cliavist administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: spine infection or spine degenerative disease patient agreement obtained Exclusion Criteria: pregnancy MRI contra-indications cliavist contra-indication dextran allergy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean-Louis Dietemann, MD

Phone

(33) 3 88127888

jean-louis.dietemann@chru-strasbourg.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Stéphane Kremer, MD

Phone

(33) 3 88127888

stephane.kremer@chru-strasbourg.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Louis Dietemann, MD

Organizational Affiliation

Hôpitaux Universitaires de Strasbourg

Official's Role

Study Director

Facility Information:

Facility Name

Service de Neuroradiologie - Hôpital Central

City

Nancy

ZIP/Postal Code

54035

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Serge Bracard, MD

s.bracard@chu-nancy.fr

First Name & Middle Initial & Last Name & Degree

Emmanuelle Schmitt, MD

e.schmitt@chu-nancy.fr

First Name & Middle Initial & Last Name & Degree

Serge Bracard, MD

First Name & Middle Initial & Last Name & Degree

Emmanuelle Schmitt, MD

Facility Name

Nouvel Hôpital Civil

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guillaume BIERRY, MD

Phone

33 (3) 88116280

guillaume.bierry@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Guillaume BIERRY, MD

Facility Name

Service de Radiologie 2 - Hôpital de Hautepierre

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-louis Dietemann, MD

jean-louis.dietemann@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Stephane Kremer, MD

stephane.kremer@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Jean-Louis Dietemann, MD

First Name & Middle Initial & Last Name & Degree

Stéphane Kremer, MD

Facility Name

Service de Rhumatologie - Hôpital de Hautepierre

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Sibilia, MD

jean.sibilia@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Jean Sibilia, MD

12. IPD Sharing Statement

Learn more about this trial

Cliavist in Infectious and Degenerative Diseases of the Spine

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