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Enrolling by Invitation

NCT Number: NCT05805839

A Study of Imaging in Demyelinating Diseases

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).

Enrolling by Invitation

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Inflammatory Demyelinating Disease Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

C-11 ER176 Radiotracer

Drug

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).

C11 Pittsburgh Compound B

Drug

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).

PET/CT scan

Diagnostic Test

Imaging of entire brain

MRI

Diagnostic Test

Magnetic Resonance Imaging of the Brain

Primary outcomes

  1. 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)

  2. Uptake of C-11 ER176 Radiotracer

    Time frame: Baseline

    C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: 2 days

    Total number of subjects to experience adverse events

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 10, 2023
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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