Imaging of Intracerebral Inflammation in MS
关键词
抽象
描述
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 healthy volunteers aging from 18 to 65 years. These healthy volunteers will be matched for age and sex with patients (1/2).
- Group II: 15 patients aging from 18 to 65 years with relapsing-remitting (RRMS), with less than 10 years of evolution since the first manifestation and no recent relapse.
- Group III: 15 patients aging from 18 to 65 years with secondary progressive MS (SPMS), with less than 10 years of evolution since the occurrence of the secondary progressive phase.
- Group III: 15 patients aging from 18 to 65 years with primary progressive MS (PPMS) diagnosed since less than 10 years.
Study centres MS patients and the 20 healthy volunteers will be recruited in the Hospital Pitie-Salpetriere
MS patients will be recruited in the Hospital Tenon
This study will be performed by complementary teams already collaborating on molecular imaging trials in MS (which assess neuronal loss or demyelination/remyelination): i) the "Centre d'Investigation Clinique" (Salpetriere hospital, Paris), which is strongly experienced in the coordination of clinical and translational research on MS; ii) the CENIR (centre for neuroimaging research, Salpetriere hospital, Paris) a specialized MRI centre for research on neurological diseases; iii) the SHFJ (DSV, CEA, ORSAY) which is a world class molecular imaging centre;
Study duration Per patient the study will last two years Per control the study will last up to 8 weeks
日期
| 最后验证: | 01/31/2017 |
| 首次提交: | 01/24/2013 |
| 提交的预估入学人数: | 11/26/2014 |
| 首次发布: | 12/01/2014 |
| 上次提交的更新: | 02/19/2017 |
| 最近更新发布: | 02/22/2017 |
| 实际学习开始日期: | 01/31/2012 |
| 预计主要完成日期: | 01/31/2018 |
| 预计完成日期: | 01/31/2018 |
状况或疾病
干预/治疗
Drug: PET -18F-DPA-714 and 18F-FDG
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: PET -18F-DPA-714 and 18F-FDG 18F-DPA-714, dose 5mCi (185MBq), will be injected via an arm intravenous catheter.
18F-FDG , dose 5mCi(185MBq), will be injected via an arm intravenous catheter. | Drug: PET -18F-DPA-714 and 18F-FDG Positron emission tomography (PET) imaging following the injection of 2 radiotracers (here considered as the drugs): 1) 18F-DPA-714 ii) 18F-FDG. PET -18F-DPA-714, dose 5mCi (185MBq), will be injected via an arm intravenous catheter.
18F-FDG , dose 5mci(185MBq), will be injected via an arm intravenous catheter. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. Whole brain Binding Potential (BP) of 18F-DPA-714 [D0]
次要成果指标
1. Binding potential of 18F-DPA-714 in segmented brain regions [D0]
2. Binding potential of 18F-DPA-714 in subgroups of MS patients [D0]
3. Predictive value of PET 18F-DPA-714 BP on neurological clinical metrics [2 years]
4. Predictive value of PET 18F-DPA-714 BP on MRI metrics [2 years]
