C-11 MRB PET imaging of the brain's norepinephrine system in people with MS

Molecular Imaging of Norepinephrine Transporter (NET) Using [C-11]Methylreboxetine PET in Multiple Sclerosis

This project will try C-11 MRB PET scans to see if the brain's norepinephrine transporter is lower in adults with multiple sclerosis than in similar healthy adults.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT03207464 on ClinicalTrials.gov

What this trial studies

This interventional imaging study uses the radioligand C-11 MRB with PET to measure norepinephrine transporter (NET) binding in the brains of people with multiple sclerosis (MS) and age- and sex-matched healthy controls. The protocol plans to enroll 12 participants (about 8 with MS and 4 healthy controls), all aged 18–70 with MS patients having EDSS below 7.5, who will undergo MRI and a roughly 120-minute PET scan. Researchers will compare NET binding between groups and correlate binding measures with clinical severity and MRI parameters. The radiotracer dose is low and not expected to cause pharmacologic effects, but participants will have small radiation exposure and must meet safety and medication exclusion criteria.

Who should consider this trial

Good fit: Adults 18–70 years old who meet the international criteria for MS with EDSS under 7.5, who can safely undergo PET and MRI, are not pregnant or nursing, and are not taking excluded antidepressant medications would be ideal candidates.

Not a fit: People who are pregnant or nursing, cannot undergo MRI/PET (for example due to incompatible implants or severe claustrophobia), are taking excluded norepinephrine-active drugs, or expect direct therapeutic benefit are unlikely to gain clinical benefit from participation.

Why it matters

Potential benefit: If successful, the approach could provide a new biomarker to detect noradrenergic system injury in MS and help link those changes to clinical severity.

How similar studies have performed: C-11 MRB PET has been used to image NET in other neurologic and psychiatric conditions, but applying it specifically to MS is relatively novel and supported only by limited prior data.

Eligibility criteria

Inclusion Criteria:

1. Individuals meeting the definition for Multiple Sclerosis by the International Panel Criteria, with an Expanded Disability Status Scale (EDSS) less than 7.5
2. Male and female subjects age 18 to 70 years
3. Subjects willing to undergo PET and MRI imaging
4. Subjects willing and able to give informed consent

Exclusion Criteria:

1. Individuals with a comorbid severe psychiatric condition such as schizophrenia, bipolar disorder, or post-traumatic stress disorder.
2. Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
3. Individuals taking tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, or norepinephrine-dopamine reuptake inhibitors.
4. Concurrent medical conditions that contraindicate study procedures.
5. Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.
6. Claustrophobia
7. Non-MRI compatible implanted devices
8. Corticosteroid treatment in the past four weeks

Where this trial is running

Boston, Massachusetts

• Brigham MS Center, 60 Fenwood Road — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Tarun Singhal, M.D. — Brigham and Women's Hospital
• Study coordinator: Tarun Singhal, M.D.

Conditions Multiple Sclerosis