Status:
COMPLETED
Imaging of Intracerebral Inflammation in MS
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Secondary Progressive
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In this study we plan to image the compartmentalized inflammation in MS using molecular imaging by positron emission tomography (PET) with a very highly resolutive camera. Two tracers will be studied ...
Detailed Description
Study design This study is a prospective cross-sectional controlled multicentric clinical study in 45 MS patients and 20 controls. Four groups of person will be included and compared: * Group I: 20 ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Healthy volunteers (group I, n=20)
- Aged 18-65 years;
- Able to understand the objectives and procedures of the study, and who give inform consent.
- Patients with relapsing-remitting MS (group II, n=15)
- Aged 18-65 years
- Clinically definite MS according to McDonald revised criteria
- Less than 10 year of evolution
- No clinical relapse during the past 3 months
- Able to understand the objectives and procedures of the study, and who give inform consent
- Patients with progressive MS (group III and IV, n=15 per group)
- Aged 18-65 years
- Clinically definite MS according to McDonald revised criteria
- SPMS evolving since more than 10 years for group III (n = 15).
- PPMS evolving since less than 10 years for group IV (n=15).
- Each progressive patient should have experienced a significant progression during the 2 years preceding the inclusion (with an estimated progression of the EDSS score of at least 0.5 point).
- No clinical relapse during the past 3 months
- Able to understand the objectives and procedures of the study, and who give inform consent.
- Exclusion criteria
- Any reason, which does not allow performing MRI: claustrophobia, pace-maker or intra-ocular foreign body for example.
- For women: pregnancy, lactation, lack of efficient contraception. At visit 2, a positive pregnancy test will lead to exclude the patient.
- Uncontrolled diabetes
- Current symptoms of severe or uncontrolled renal, hepatic, hematological, gastrointestinal pulmonary or cardiac disease.
- Positive HIV test
- Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual guidelines.
- Other chronic neurological disease.
Exclusion
Key Trial Info
Start Date :
March 19 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2018
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT02305264
Start Date
March 19 2012
End Date
September 10 2018
Last Update
September 16 2022
Active Locations (2)
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1
Saint Antoine Hospital
Paris, France, 75012
2
Pitie Salpetriere Hospital
Paris, France, 75013