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Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
pet-scan FDG-F18
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MRI, PET scan

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with MS
  • Treatment with Tysabri planned

Exclusion Criteria:

  • Allergy to Tysabri or MRI contrast products
  • Pregnancy

Sites / Locations

  • Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
  • Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
  • Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Outcomes

Primary Outcome Measures

Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain).

Secondary Outcome Measures

Correlation with relapses.

Full Information

First Posted
September 11, 2008
Last Updated
November 9, 2012
Sponsor
University Hospital, Strasbourg, France
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00752778
Brief Title
Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri
Official Title
MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the diagnosis value of MRI and positon emission tomography (PET) scan for studying macrophagic infiltration and other brain modification in multiple sclerosis (MS) patients treated with Natalizumab (Tysabri).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
MRI, PET scan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
pet-scan FDG-F18
Primary Outcome Measure Information:
Title
Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain).
Time Frame
At baseline and after 3 months of treatment.
Secondary Outcome Measure Information:
Title
Correlation with relapses.
Time Frame
During the 3 months of treatment and the 3 following months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with MS Treatment with Tysabri planned Exclusion Criteria: Allergy to Tysabri or MRI contrast products Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme DE SEZE, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
37091
Country
France
Facility Name
Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

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Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

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