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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of advanced imaging techniques, such as MRI and PET/CT scans, in measuring brain inflammation related to Multiple Sclerosis (MS). Participants will undergo these scans to help researchers understand how inflammation impacts the brain in MS. The trial includes two groups: one with individuals diagnosed with MS and another with healthy individuals without central nervous system inflammation. It suits those who either have MS or are healthy without inflammatory brain conditions and can remain still for about 20 minutes during the scans. As a Phase 2 trial, this research focuses on assessing the imaging techniques' effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in MS diagnostics.

Will I have to stop taking my current medications?

You may need to stop taking certain medications like glucocorticoids (a type of steroid) for at least 2 weeks before the trial. However, if you are on chronic disease-modifying treatments for MS, you can continue taking them.

What prior data suggests that these imaging techniques are safe for measuring brain inflammation in MS?

Research has shown that both C-11 ER176 and C11 Pittsburgh Compound B have been safe in earlier studies. Specifically, a study found that C-11 ER176 can be safely administered through a single IV dose before PET scans, indicating it is generally well-tolerated. C11 Pittsburgh Compound B is frequently used in brain scans to study amyloid plaques and has been safely used in numerous studies with patients who have Multiple Sclerosis (MS).

These findings suggest that both radiotracers are generally well-tolerated in humans. However, since this trial remains in the early stages, more information is needed about their safety in different populations. Prospective participants should discuss any concerns with a healthcare professional. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these imaging techniques for multiple sclerosis because they offer a new way to understand and track the disease. Unlike traditional MRI scans, which only show structural changes in the brain, the use of C-11 ER176 and C11 Pittsburgh Compound B radiotracers in PET/CT scans can highlight active inflammation and plaque formation. This approach could provide more detailed insights into the disease's progression and response to treatment, potentially leading to more personalized care for patients.

What evidence suggests that these imaging techniques are effective for measuring brain inflammation in Multiple Sclerosis?

Research has shown that the C-11 ER176 radiotracer, administered to participants in the Multiple Sclerosis Group of this trial, can help detect brain inflammation in people with multiple sclerosis (MS). One study found that increased activity of this radiotracer in the thalamus (a part of the brain) correlates with worse disability in MS patients, suggesting its usefulness in assessing MS severity.

For the C11 Pittsburgh Compound B, also used in the Multiple Sclerosis Group, studies have indicated it might aid in imaging the brain to study MS. It can identify changes in the brain's white matter related to thinking and memory in MS patients. Both imaging techniques aim to provide a clearer picture of how MS affects the brain. ^{1 2 3 6 7}

Who Is on the Research Team?

Burcu Zeydan, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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

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

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

Exclusion Criteria

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

Women who are pregnant or cannot stop breastfeeding for 24 hours

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5288742/

11C-ER176, a Radioligand for 18-kDa Translocator Protein ... The effective dose was 4.1 ± 0.4 μSv/MBq (Supplemental Table 3), which is similar to that of other 11C-labeled radioligands (23). Kinetic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12046125/

Microglia positron emission tomography and progression in ... In patients with multiple sclerosis, higher thalamus 11C-ER176 PET uptake correlated with worse expanded disability status scale scores (r = 0.33, P = 0.02), ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05805839

A Study of Imaging in Demyelinating Diseases | ... 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).

4. jnm.snmjournals.org jnm.snmjournals.org/content/63/8/1252

In Vivo Evaluation of 6 Analogs of 11C-ER176 as Candidate ... The radioligand 11 C-ER176 can successfully image 18-kDa translocator protein (TSPO), a biomarker of inflammation, in the human brain and accurately quantify ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000210047

Journal Club: PET Imaging in Multiple Sclerosis and Its ... The short 20-minute half-life of the C-11 radioisotope is restrictive for scanning logistics, image quality at the time of equilibrium (related ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/1352458518791680?int.sj-abstract.similar-articles.9

Positron emission tomography imaging in evaluation of MS ... The sensitivity of only one second-generation tracer, namely, [11C]ER176, has been shown to be sufficient enough for the quantification of all ...

7. pubs.acs.org pubs.acs.org/doi/10.1021/acsptsci.3c00200

Development and Optimization of 11C-Labeled Radiotracers This article briefly reviews the development or optimization of pharmaceutical 11C-tracers for PET imaging, considering the QC and regulatory ...