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

This study is not yet open for participant recruitment.
Verified June 2017 by Tarun Singhal, Brigham and Women's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03207464
First Posted: July 2, 2017
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tarun Singhal, Brigham and Women's Hospital
  Purpose

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.

Condition Intervention Phase
Multiple Sclerosis Drug: [C-11]Methylreboxetine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular Imaging of Norepinephrine Transporter (NET) Using [C-11]Methylreboxetine PET in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Tarun Singhal, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Tissue Volume of Distribution [ Time Frame: 1 month ]
    PET Imaging measurement


Estimated Enrollment: 8
Anticipated Study Start Date: August 1, 2017
Estimated Study Completion Date: June 1, 2018
Estimated Primary Completion Date: June 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multiple Sclerosis
Subjects meeting the definition for Multiple Sclerosis by the International Panel Criteria19, with an Expanded Disability Status Scale (EDSS) less than 6.5.
Drug: [C-11]Methylreboxetine
4 individuals with Multiple Sclerosis will undergo a [C-11]MRB PET scan and a MRI scan.
Experimental: Healthy Control
This group will serve as non disease population.
Drug: [C-11]Methylreboxetine
4 individuals with Multiple Sclerosis will undergo a [C-11]MRB PET scan and a MRI scan.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female subjects age 18 to 60 years
  2. Subjects willing to undergo PET and MRI imaging
  3. 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. Concurrent medical conditions that contraindicate study procedures.
  4. 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.
  5. Claustrophobia
  6. Non-MRI compatible implanted devices
  7. Corticosteroid treatment in the past four weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207464


Contacts
Contact: Tarun Singhal, M.D. 6172643043 tsinghal@partners.org

Locations
United States, Massachusetts
Partners MS Center, 60 Fenwood Road Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Kelsey Oconnor    617-264-3044    koconnor25@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Tarun Singhal, M.D. Brigham and Women's Hospital
  More Information

Responsible Party: Tarun Singhal, M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03207464     History of Changes
Other Study ID Numbers: 2016D007737
First Submitted: June 30, 2017
First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents