A Study of Imaging in Demyelinating Diseases
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Healthy Control Group Subjects without inflammatory-demyelinating diseases of the central nervous system |
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
|
| Experimental: 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 |
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
|
Outcome Measures
Primary Outcome Measures
- Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin [Baseline]
C-11 Pittsburgh compound-B (PiB) in PET imaging measured by PiB standardized uptake value ratio (SUVr)
- Uptake of C-11 ER176 Radiotracer [Baseline]
C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr
Secondary Outcome Measures
- Number of subjects with adverse events [2 days]
Total number of subjects to experience adverse events
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Minnesota | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Burcu Zeydan, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 22-009149