Enrolling by invitation NCT05805839
A Study of Imaging in Demyelinating Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: C-11 ER176 Radiotracer, C11 Pittsburgh Compound B, PET/CT scan, MRI.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Inflammatory Demyelinating Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Advanced MR and PET Imaging in Inflammatory Demyelinating Diseases of the Central Nervous System
Overview
This purpose of this study is research the usefulness of MRI with PET/CT imaging for measuring brain inflammation and its relation to Multiple Sclerosis (MS).
Interventions
- Drug 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). - Drug 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). - Diagnostic test PET/CT scan
Imaging of entire brain - Diagnostic test MRI
Magnetic Resonance Imaging of the Brain
Primary outcome measures
- Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin [Time frame: Baseline]
- Uptake of C-11 ER176 Radiotracer [Time frame: Baseline]
Secondary outcome measures (1)
- Number of subjects with adverse events [Time frame: 2 days]
Eligibility criteria
Inclusion criteria
- Meet the requirements for one of the case or control groups.
- 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
- Participants unable to lie down without moving for 20 minutes.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
Identifiers
NCT: NCT05805839 · 22-009149