Imaging Techniques for Multiple Sclerosis

Overseen By June Kendall-Thomas

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Glucocorticoids

Disqualifiers: Pregnancy, Breastfeeding, Metallic foreign bodies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Burcu Zeydan, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with Multiple Sclerosis (MS) who are already part of certain MS studies or clinics, and healthy controls without inflammatory brain diseases. Participants must be able to lie still for imaging procedures and give consent. Pregnant or breastfeeding women, recent steroid users, and those with MRI safety risks like pacemakers can't join.

Inclusion Criteria

I do not have any inflammatory brain or spinal cord diseases.

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

Exclusion Criteria

Women who are pregnant or cannot stop breastfeeding for 24 hours

I haven't taken any steroids in the last 2 weeks.

Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo MRI with PET/CT imaging to measure brain inflammation

Baseline

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

2 days

Treatment Details

Interventions

• C-11 ER176 Radiotracer
• C11 Pittsburgh Compound B
• MRI
• PET/CT scan

Trial Overview The study is testing the effectiveness of combining MRI scans with PET/CT imaging using C-11 ER176 Radiotracer and C11 Pittsburgh Compound B to measure brain inflammation in people with MS.

Participant Groups

Group I: Multiple Sclerosis Group Experimental Treatment 4 Interventions

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

Group II: Healthy Control Group Experimental Treatment 4 Interventions

Subjects without inflammatory-demyelinating diseases of the central nervous system

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+