Cliavist in Infectious and Degenerative Diseases of the Spine

February 24, 2009 updated by: University Hospital, Strasbourg, France

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54035
        • Not yet recruiting
        • Service de Neuroradiologie - Hôpital Central
        • Contact:
        • Contact:
        • Principal Investigator:
          • Serge Bracard, MD
        • Sub-Investigator:
          • Emmanuelle Schmitt, MD
      • Strasbourg, France, 67091
        • Not yet recruiting
        • Nouvel Hôpital Civil
        • Contact:
        • Principal Investigator:
          • Guillaume BIERRY, MD
      • Strasbourg, France, 67098
      • Strasbourg, France, 67098
        • Not yet recruiting
        • Service de Rhumatologie - Hôpital de Hautepierre
        • Contact:
        • Principal Investigator:
          • Jean Sibilia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • spine infection or spine degenerative disease
  • patient agreement obtained

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cliavist
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First MRI: performed immediately after gadolinium administration
Time Frame: immediately after gadolinium administration
immediately after gadolinium administration
Second MRI: performed 24 hours after cliavist administration
Time Frame: 24 hours after cliavist administration
24 hours after cliavist administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Jean-Louis Dietemann, MD, Hôpitaux universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

September 4, 2006

First Submitted That Met QC Criteria

September 4, 2006

First Posted (Estimate)

September 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 25, 2009

Last Update Submitted That Met QC Criteria

February 24, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3780

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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