A Study of Imaging in Demyelinating Diseases

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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis; Inflammatory Demyelinating Disease
• Intervention / Treatment: Drug: C-11 ER176 Radiotracer; Drug: C11 Pittsburgh Compound B; Diagnostic test: PET/CT scan; Diagnostic test: MRI

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: June Kendall-Thomas; Phone Number: 507-538-7358; Email: kendallthomas.june15@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Control Group; Subjects without inflammatory-demyelinating diseases of the central nervous system	Drug: C-11 ER176 Radiotracer; 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).; Drug: C11 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).; Diagnostic test: PET/CT scan; Imaging of entire brain; Diagnostic test: MRI; Magnetic Resonance Imaging of the Brain
Experimental: 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	Drug: C-11 ER176 Radiotracer; 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).; Drug: C11 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).; Diagnostic test: PET/CT scan; Imaging of entire brain; Diagnostic test: MRI; Magnetic Resonance Imaging of the Brain

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Burcu Zeydan, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Multiple Sclerosis; Demyelinating Diseases; Anti-Inflammatory Agents; Corticosterone
• Other Study ID Numbers: 22-009149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No