A Study of Imaging in Demyelinating Diseases

Study Overview
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Brief Summary
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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).

Official Title
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Advanced MR and PET Imaging in Inflammatory Demyelinating Diseases of the Central Nervous System

Conditions
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Multiple Sclerosis, Inflammatory Demyelinating Disease

Intervention / Treatment
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* Drug: C-11 ER176 Radiotracer
* Drug: C11 Pittsburgh Compound B
* Diagnostic Test: PET/CT scan
* Diagnostic Test: MRI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Control Group<br>Subjects without inflammatory-demyelinating diseases of the central nervous system | Drug: C-11 ER176 Radiotracer<br>* 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).<br>Drug: C11 Pittsburgh Compound B<br>* 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).<br>Diagnostic Test: PET/CT scan<br>* Imaging of entire brain<br>Diagnostic Test: MRI<br>* Magnetic Resonance Imaging of the Brain<br>|
| Experimental: Multiple Sclerosis Group<br>Subjects with current diagnosis of Multiple Sclerosis or an InflammatoryDemyelinating Disease of the Central Nervous System will have a PET/CT scan with radiotracer drug C-11 PIB & C-11 ER176 | Drug: C-11 ER176 Radiotracer<br>* 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).<br>Drug: C11 Pittsburgh Compound B<br>* 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).<br>Diagnostic Test: PET/CT scan<br>* Imaging of entire brain<br>Diagnostic Test: MRI<br>* Magnetic Resonance Imaging of the Brain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin | C-11 Pittsburgh compound-B (PiB) in PET imaging measured by PiB standardized uptake value ratio (SUVr) | Baseline | 
| Uptake of C-11 ER176 Radiotracer | C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events | Total number of subjects to experience adverse events | 2 days |