Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri
November 9, 2012 updated by: University Hospital, Strasbourg, France
MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 4
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
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Strasbourg, France, 37091
- Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
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Strasbourg, France, 67098
- Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
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Strasbourg, France, 67098
- Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
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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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients diagnosed with MS
- Treatment with Tysabri planned
Exclusion Criteria:
- Allergy to Tysabri or MRI contrast products
- Pregnancy
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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.
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At baseline and after 3 months of treatment.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Correlation with relapses.
Time Frame: During the 3 months of treatment and the 3 following months.
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During the 3 months of treatment and the 3 following months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jérôme DE SEZE, MD, Hopitaux 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
December 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
September 11, 2008
First Submitted That Met QC Criteria
September 12, 2008
First Posted (Estimate)
September 15, 2008
Study Record Updates
Last Update Posted (Estimate)
November 12, 2012
Last Update Submitted That Met QC Criteria
November 9, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4118
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.