Molecular Imaging of NET Using [C-11]MRB-PET in MS

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT03207464
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • [C-11]Methylreboxetine — DRUG
    8 individuals with Multiple Sclerosis and 4 healthy controls will undergo a \[C-11\]MRB PET scan and a MRI scan.

Study Details

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.

Key Dates

Start date
Oct 10, 2017
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
19 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.
  • Experimental: Healthy Control
    This group will serve as non disease population.

Primary Outcome Measure

[C-11]Methylreboxetine area under the curve ratios [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham MS Center, 60 Fenwood RoadBostonMassachusetts02115
Steven Cicero
[email protected]
617-264-3044

Find similar trials in Boston, MA

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Brigham MS Center, 60 Fenwood Road· Boston, MA

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