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

NCT03207464 | Recruiting Phase 1 DMC

• 1 other identifier: 2017P001099
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.To determine correlation of norepinephrine transporter binding with clinical severity and MRI parameters in MS.
3. 3.To determine correlation of norepinephrine transporter binding with fatigue and cognitive impairment in MS patients.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• [C-11]Methylreboxetine area under the curve ratios

  PET Imaging measurement

  Baseline

Study Arms (2)

Multiple Sclerosis

EXPERIMENTAL

Subjects meeting the definition for Multiple Sclerosis by the International Panel Criteria, with an Expanded Disability Status Scale (EDSS) less than 6.5.

Drug: [C-11]Methylreboxetine

Healthy Control

EXPERIMENTAL

This group will serve as non disease population.

Drug: [C-11]Methylreboxetine

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.

Also known as: [C-11]MRB

Healthy Control; Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham MS Center, 60 Fenwood Road

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tarun Singhal, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarun Singhal, M.D.

CONTACT

617-264-3043; tsinghal@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: October 10, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)