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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "To determine correlation of norepinephrine transporter binding with clinical severity and MRI parameters in MS. 3."
  • "Subject Safety: Subject monitoring during MRI and PET scans will be performed using a 2-way intercom system between the scanner operator and subject and by visual monitoring of the subject through the window into the scan room (the subject is visible to the operator at all times)."
  • "The MRI scans take place in a confined space that makes some people claustrophobic."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses a PET brain scan called [C-11]MRB PET to look for signs of brain injury in people with multiple sclerosis (MS), compared with healthy people. It will also look at how scan results relate to MS severity, tiredness, and problems with thinking.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have MS that meets international diagnosis rules, with a score below 7.5 on the EDSS scale, which measures disability from MS.
  • Be 18 to 70 years old. Men and women may join.
  • Be willing to have PET and MRI scans, which take pictures of the brain.
  • Be willing and able to give informed consent, meaning you understand the study and agree to join.

Who can't join

  • Have a severe mental health condition, such as schizophrenia, bipolar disorder, or post-traumatic stress disorder (PTSD).
  • Have another known brain or nerve disorder, a past head injury, or substance abuse.
  • Take certain antidepressants: tricyclics, serotonin-norepinephrine reuptake inhibitors (SNRIs), or norepinephrine-dopamine reuptake inhibitors (NDRIs).
  • Have another medical condition that makes study procedures unsafe.
  • Be pregnant, breastfeeding, trying to become pregnant, or think you may be pregnant.
  • Have claustrophobia, a fear of small or closed spaces.
  • Have an implanted device that is not safe for MRI scans.
  • Have had corticosteroid treatment, a type of steroid medicine, in the past four weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Individuals meeting the definition for Multiple Sclerosis by the International Panel Criteria, with an Expanded Disability Status Scale (EDSS) less than 7.5 2. Male and female subjects age 18 to 70 years 3. Subjects willing to undergo PET and MRI imaging 4. 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

Study sites (1)

MA