To Study the Pathophysiological Features of Multiple Sclerosis
|ClinicalTrials.gov Identifier: NCT04242056|
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Neurofilament Light Chain Glial Fibrillary Acidic Protein||Drug: 18F-PM-PBB3||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||To Study the Pathophysiological Features of Multiple Sclerosis: Combined Multi-modalities of Amyloid and Tau Images Associated With Serum Neurofilament Light Chain Levels|
|Estimated Study Start Date :||February 20, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Using image to diagnosis Multiple sclerosis (MS)
In current study, we will enroll 38 patients with MS and evaluate their clinical severity; measure the WM lesion and disease activity by magnetic resonance imaging (MRI); myelination state and amyloid deposition by amyloid PET scan; tau deposition by state of-art tau PET scan
18F-PM-PBB3 brain PET studies will be conducted for 38 subjects. Dynamic PET/MRI studies will be collected by PET/MRI scanner for 100 minutes (4×15 s, 8×30 s, 960 s, 2×180 s, 8300 s, 3×600 s). Volumes of interest (VOIs) will be delineated from corresponding MR images by manual including bilateral frontal, parietal, mesial temporal, lateral temporal, hippocampal, occipital, anterior cingulate, posterior cingulate, cerebellum areas, and genu region of white matter. The DVRs will be computed from Logan graphic analysis by using cerebellum as reference input.
SUVR of every cortical VOI to the gray matter of cerebellum will be calculated from nine 10-min dynamic image sets.
- Correlation between hyperintensity lesions in FLAIR MRI and demyelination in amyloid PET image [ Time Frame: 3 years ]Investigator would be able to find the topographical correlation between hyperintensity lesions in FLAIR MRI and hypointensity lesions in amyloid PET, measurement by overlapping volume (ml) and overlapping ratio (%)
- Correlation between clinical parameters (EDSS) and hyperintensity lesions in FLAIR MRI and hyperintensity region of tau PET image light chain and GFAP levels. [ Time Frame: 3 years ]Investigator would be able to find the EDSS correlation between whole brain hyperintensity lesions in FLAIR MRI (ml) and hyperintensity regions of tau PETwe will take this advantage to perform the study and explore the relationship between serum neruofilament light chain and GFAP levels.
- Correlation between clinical parameters (EDSS) and serum NfL levels [ Time Frame: 3 years ]Investigator would be able to find the EDSS correlation between EDSS and serum NfL levels