Advanced MR and PET Imaging in Inflammatory Demyelinating Diseases of the Central Nervous System
Overview
- Phase
- Phase 2
- Intervention
- C-11 ER176 Radiotracer
- Conditions
- Multiple Sclerosis
- Sponsor
- Mayo Clinic
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin
- Status
- Enrolling by Invitation
- Last Updated
- 8 months ago
Overview
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).
Investigators
Burcu Zeydan
Principal Investigator
Mayo Clinic
Eligibility Criteria
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.
Arms & Interventions
Healthy Control Group
Subjects without inflammatory-demyelinating diseases of the central nervous system
Intervention: C-11 ER176 Radiotracer
Healthy Control Group
Subjects without inflammatory-demyelinating diseases of the central nervous system
Intervention: C11 Pittsburgh Compound B
Healthy Control Group
Subjects without inflammatory-demyelinating diseases of the central nervous system
Intervention: PET/CT scan
Healthy Control Group
Subjects without inflammatory-demyelinating diseases of the central nervous system
Intervention: MRI
Multiple Sclerosis Group
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
Intervention: C-11 ER176 Radiotracer
Multiple Sclerosis Group
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
Intervention: C11 Pittsburgh Compound B
Multiple Sclerosis Group
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
Intervention: PET/CT scan
Multiple Sclerosis Group
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
Intervention: MRI
Outcomes
Primary Outcomes
Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin
Time Frame: Baseline
C-11 Pittsburgh compound-B (PiB) in PET imaging measured by PiB standardized uptake value ratio (SUVr)
Uptake of C-11 ER176 Radiotracer
Time Frame: Baseline
C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr
Secondary Outcomes
- Number of subjects with adverse events(2 days)