A preliminary, multicenter study on the relationship between cortical
A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity. Correlation between [11C]-PK-11195 or [18F]-NAF PET (Positron Emission Tomography) and high field MRI (Magnetic Resonance Imaging): a synergistic effect by using a double-technique approach.
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Na18F
- [11C]-PK-11195
What it measured
Main measures
To detect the presence of cortical lesions in PET images at timepoint t=40 minutes for 18F-Na and at timepoint t=20 minutes for PK11195 . To verify if these lesions are also detected by MRI sequences
MRI lesions
Other measures (1)
1.To quantify, by using [11C]-PK11195-PET, microglial activation degree within cortical lesions and ¿MRI normal appearing grey matter¿ at t=20 minutes - To estimate the correlation of microglial activation with some demographic and clinical data (age, disease duration, disability, EDSS) 2- To quantify, by using [18F]-NaF-PET, blood brain barrier damage signs in cortical lesions at t=40 minutes - T
Disability progressionMRI lesionsSmouldering inflammation
Who could take part
MS (type not specified)
Show the full criteria
Inclusion criteria
Inclusion: - Sex: Female and Male Exclusion: - Co-occurring of other illness that can alter PET imaging (neoplasms, infectious disease, etc)
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Primary objectives of this study are:
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History
Started
Jun 2021