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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03207464
Recruitment Status : Unknown
Verified June 2018 by Tarun Singhal, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
First Posted : July 2, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Tarun Singhal, Brigham and Women's Hospital

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. 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 or disease Intervention/treatment Phase
Multiple Sclerosis Drug: [C-11]Methylreboxetine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
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
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
8 individuals with Multiple Sclerosis and 4 healthy controls 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
8 individuals with Multiple Sclerosis and 4 healthy controls will undergo a [C-11]MRB PET scan and a MRI scan.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Individuals taking tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, or norepinephrine-dopamine reuptake inhibitors.
  4. Concurrent medical conditions that contraindicate study procedures.
  5. 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.
  6. Claustrophobia
  7. Non-MRI compatible implanted devices
  8. Corticosteroid treatment in the past four weeks

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

Locations
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United States, Massachusetts
Partners MS Center, 60 Fenwood Road Recruiting
Boston, Massachusetts, United States, 02115
Contact: Steven Cicero    617-264-3044    scicero@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Tarun Singhal, M.D. Brigham and Women's Hospital
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Responsible Party: Tarun Singhal, M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03207464    
Other Study ID Numbers: 2016D007737
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases