Molecular Imaging of NET Using [C-11]MRB-PET in MS
Recruiting · NCT03207464 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study aims to use \[C-11\]MRB PET (positron emission tomography) imaging to look at brain injury in patients with Multiple Sclerosis (MS) and healthy individuals. The overarching hypothesis is that there is decreased radioligand binding to the norepinephrine transporter in multiple sclerosis, reflecting injury to the noradrenergic system and that it plays a role in disease pathogenesis, its clinical manifestations and severity. This strategy is targeted to address an unmet need because currently available MRI techniques lack sensitivity and specificity for assessing such changes in the brains of people with MS. The specific aims of the study are: 1. To determine norepinephrine transporter binding in the brains of MS patients using \[C-11\]MRB PET and compare it with age, and sex matched healthy controls. 2. To determine correlation of norepinephrine transporter binding with clinical severity and MRI parameters in MS. 3. To determine correlation of norepinephrine transporter binding with fatigue and cognitive impairment in MS patients.
Who can take part
Inclusion criteria
- Individuals meeting the definition for Multiple Sclerosis by the International Panel Criteria, with an Expanded Disability Status Scale (EDSS) less than 7.5
- Male and female subjects age 18 to 70 years
- Subjects willing to undergo PET and MRI imaging
- Subjects willing and able to give informed consent
Exclusion criteria
- Individuals with a comorbid severe psychiatric condition such as schizophrenia, bipolar disorder, or post-traumatic stress disorder.
- Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
- Individuals taking tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, or norepinephrine-dopamine reuptake inhibitors.
- Concurrent medical conditions that contraindicate study procedures.
- 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.
- Claustrophobia
- Non-MRI compatible implanted devices
- Corticosteroid treatment in the past four weeks
Where it is running
1 location listed across 1 US state.
- Brigham MS Center, 60 Fenwood Road - Boston, Massachusetts, United States