A Study of Imaging in Demyelinating Diseases

Mayo Clinic

Status and phase: Invitation-only; Phase 2

Conditions: Multiple Sclerosis; Inflammatory Demyelinating Disease

Treatments: Diagnostic Test: PET/CT scan; Drug: C-11 ER176 Radiotracer; Drug: C11 Pittsburgh Compound B; Diagnostic Test: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT05805839

22-009149

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Healthy Control Group

Experimental group

Description:

Subjects without inflammatory-demyelinating diseases of the central nervous system

Treatment:

Diagnostic Test: MRI

Drug: C11 Pittsburgh Compound B

Drug: C-11 ER176 Radiotracer

Diagnostic Test: PET/CT scan

Multiple Sclerosis Group

Experimental group

Description:

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

Treatment:

Diagnostic Test: MRI

Drug: C11 Pittsburgh Compound B

Drug: C-11 ER176 Radiotracer

Diagnostic Test: PET/CT scan