Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
200 participants
INTERVENTIONAL
2023-07-10
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy Control Group
Subjects without inflammatory-demyelinating diseases of the central nervous system
C-11 ER176 Radiotracer
Administered at a single time IV prior to the PET imaging. The injected dose of C-11 ER176 will be 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi).
C11 Pittsburgh Compound B
Administered at a single time IV prior to the PET imaging. The injected dose of C-11 PiB will be 555 MBq (range 370 - 629 MBq).
PET/CT scan
Imaging of entire brain
MRI
Magnetic Resonance Imaging of the Brain
Multiple Sclerosis Group
Subjects with current diagnosis of Multiple Sclerosis or an InflammatoryDemyelinating Disease of the Central Nervous System will have a PET/CT scan with radiotracer drug C-11 PIB \& C-11 ER176
C-11 ER176 Radiotracer
Administered at a single time IV prior to the PET imaging. The injected dose of C-11 ER176 will be 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi).
C11 Pittsburgh Compound B
Administered at a single time IV prior to the PET imaging. The injected dose of C-11 PiB will be 555 MBq (range 370 - 629 MBq).
PET/CT scan
Imaging of entire brain
MRI
Magnetic Resonance Imaging of the Brain
Interventions
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C-11 ER176 Radiotracer
Administered at a single time IV prior to the PET imaging. The injected dose of C-11 ER176 will be 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi).
C11 Pittsburgh Compound B
Administered at a single time IV prior to the PET imaging. The injected dose of C-11 PiB will be 555 MBq (range 370 - 629 MBq).
PET/CT scan
Imaging of entire brain
MRI
Magnetic Resonance Imaging of the Brain
Eligibility Criteria
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Inclusion Criteria
* MS patients undergoing neurologic evaluation procedures as part of Understanding Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders (IRB# 19-002807) Study or the Mayo Clinic Neurology Multiple Sclerosis Clinic.
* Control participants without inflammatory-demyelinating diseases of the central nervous system
* Capacity to sign consent.
Exclusion Criteria
* Women who are pregnant or cannot stop breast feeding for 24 hours.
* For all patients and controls, any acute glucocorticoid (e.g., IV methylprednisolone or PO prednisolone) use within 2 weeks is an exclusion to limit medication interaction but preserve possible chronic systemic inflammation interaction with microglia activation metrics. Chronic disease modifying treatments in MS are allowed as these medications are not known to impact microglia activation.
* Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc., since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Burcu Zeydan
Principal Investigator
Principal Investigators
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Burcu Zeydan, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-009149
Identifier Type: -
Identifier Source: org_study_id
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