Multiple Sclerosis, Inflammatory Demyelinating Disease
Conditions
Brief summary
This purpose of this study is research the usefulness of MRI with PET/CT imaging for measuring brain inflammation and its relation to Multiple Sclerosis (MS).
Interventions
DIAGNOSTIC_TESTPET/CT scan
Imaging of entire brain
DIAGNOSTIC_TESTMRI
Magnetic Resonance Imaging of the Brain
Administered at a single time IV prior to the PET imaging. The injected dose of C-11 ER176 will be 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi).
DRUGC11 Pittsburgh Compound B
Administered at a single time IV prior to the PET imaging. The injected dose of C-11 PiB will be 555 MBq (range 370 - 629 MBq).
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Meet the requirements for one of the case or control groups. * MS patients undergoing neurologic evaluation procedures as part of Understanding Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders (IRB# 19-002807) Study or the Mayo Clinic Neurology Multiple Sclerosis Clinic. * Control participants without inflammatory-demyelinating diseases of the central nervous system * Capacity to sign consent.
Exclusion criteria
* Participants unable to lie down without moving for 20 minutes. * Women who are pregnant or cannot stop breast feeding for 24 hours. * For all patients and controls, any acute glucocorticoid (e.g., IV methylprednisolone or PO prednisolone) use within 2 weeks is an exclusion to limit medication interaction but preserve possible chronic systemic inflammation interaction with microglia activation metrics. Chronic disease modifying treatments in MS are allowed as these medications are not known to impact microglia activation. * Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc., since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin | Baseline | C-11 Pittsburgh compound-B (PiB) in PET imaging measured by PiB standardized uptake value ratio (SUVr) |
| Uptake of C-11 ER176 Radiotracer | Baseline | C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | 2 days | Total number of subjects to experience adverse events |
Countries
United States
Outcome results
None listed