Molecular Imaging of Norepinephrine Transporter (NET) Using [C-11]Methylreboxetine PET in Multiple Sclerosis
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- [C-11]Methylreboxetine area under the curve ratios
Study Overview
Brief Summary
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:
- 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.
- To determine correlation of norepinephrine transporter binding with clinical severity and MRI parameters in MS.
- To determine correlation of norepinephrine transporter binding with fatigue and cognitive impairment in MS patients.
Detailed Description
Two groups of subjects will be recruited:
- Individuals meeting the definition for Multiple Sclerosis by the International Panel Criteria19, with an Expanded Disability Status Scale (EDSS) less than 6.5
- Age- and sex-matched healthy controls
The goal sample size is 12 subjects including 4 healthy controls and 8 subjects with Multiple Sclerosis (MS).
Subjects will be recruited by the PI, one of the other co-investigators, or a staff member listed on the protocol at the Partners MS Center and the Behavioral Neurology Clinic of Brigham and Women's Hospital.
Side Effects Monitoring:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Multiple Sclerosis
Subjects meeting the definition for Multiple Sclerosis by the International Panel Criteria, with an Expanded Disability Status Scale (EDSS) less than 6.5.
Intervention: [C-11]Methylreboxetine (Drug)
Healthy Control
This group will serve as non disease population.
Intervention: [C-11]Methylreboxetine (Drug)
Outcomes
Primary Outcomes
[C-11]Methylreboxetine area under the curve ratios
Time Frame: Baseline
PET Imaging measurement
Secondary Outcomes
No secondary outcomes reported
Investigators
TARUN SINGHAL
Associate Professor of Neurology
Brigham and Women's Hospital