A Study of Imaging in Demyelinating Diseases

Phase 2

• Conditions: Multiple Sclerosis; Inflammatory Demyelinating Disease
• Interventions: Drug: C-11 ER176 Radiotracer; Drug: C11 Pittsburgh Compound B; Diagnostic Test: PET/CT scan; Diagnostic Test: MRI

• Registration Number: NCT05805839
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-04-10
• Study Start: 2023-07-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Control Group	C11 Pittsburgh Compound B	Subjects without inflammatory-demyelinating diseases of the central nervous system
Healthy Control Group	PET/CT scan	Subjects without inflammatory-demyelinating diseases of the central nervous system
Multiple Sclerosis Group	PET/CT scan	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
Multiple Sclerosis Group	C11 Pittsburgh Compound B	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
Healthy Control Group	C-11 ER176 Radiotracer	Subjects without inflammatory-demyelinating diseases of the central nervous system
Healthy Control Group	MRI	Subjects without inflammatory-demyelinating diseases of the central nervous system
Multiple Sclerosis Group	C-11 ER176 Radiotracer	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
Multiple Sclerosis Group	MRI	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of subjects with adverse events	2 days	Total number of subjects to experience adverse events

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States