NCT00372281

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2007

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 25, 2009

Status Verified

February 1, 2009

Enrollment Period

2.4 years

First QC Date

September 4, 2006

Last Update Submit

February 24, 2009

Conditions

Spine Infection

Keywords

MRI, CLIAVIST, MACROPHAGE, INFECTION, SPINE

Outcome Measures

Primary Outcomes (2)

  • First MRI: performed immediately after gadolinium administration

    immediately after gadolinium administration

  • Second MRI: performed 24 hours after cliavist administration

    24 hours after cliavist administration

Study Arms (1)

Cliavist

EXPERIMENTAL
Drug: Cliavist

Interventions

CliavistDRUG

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.

Cliavist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • spine infection or spine degenerative disease
  • patient agreement obtained

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Service de Neuroradiologie - Hôpital Central

Nancy, 54035, France

NOT YET RECRUITING

Nouvel Hôpital Civil

Strasbourg, 67091, France

NOT YET RECRUITING

Service de Radiologie 2 - Hôpital de Hautepierre

Strasbourg, 67098, France

RECRUITING

Service de Rhumatologie - Hôpital de Hautepierre

Strasbourg, 67098, France

NOT YET RECRUITING

MeSH Terms

Conditions

Infections

Study Officials

  • Jean-Louis Dietemann, MD

    Hôpitaux Universitaires de Strasbourg

    STUDY DIRECTOR

Central Study Contacts

Jean-Louis Dietemann, MD

CONTACT

(33) 3 88127888jean-louis.dietemann@chru-strasbourg.fr

Stéphane Kremer, MD

CONTACT

(33) 3 88127888stephane.kremer@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2006

First Posted

September 6, 2006

Study Start

March 1, 2007

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

February 25, 2009

Record last verified: 2009-02

Locations

FR(4)