NCT03207464 Molecular Imaging of NET Using [C-11]MRB-PET in MS
| NCT ID | NCT03207464 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 19 participants |
| Start Date | 2017-10-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 19 participants in total. It began in 2017-10-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Tarun Singhal, M.D.
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT03207464 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03207464 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03207464 currently recruiting?
Yes, NCT03207464 is actively recruiting participants. Contact the research team at tsinghal@bwh.harvard.edu for enrollment information.
Where is the NCT03207464 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03207464 clinical trial?
NCT03207464 is sponsored by Brigham and Women's Hospital. The principal investigator is Tarun Singhal, M.D. at Brigham and Women's Hospital. The trial plans to enroll 19 participants.
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