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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05805839
Other study ID # 22-009149
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date July 10, 2023
Est. completion date May 2025

Study information

Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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).
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
MRI
Magnetic Resonance Imaging of the Brain

Locations

Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin C-11 Pittsburgh compound-B (PiB) in PET imaging measured by PiB standardized uptake value ratio (SUVr) Baseline
Primary Uptake of C-11 ER176 Radiotracer C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr Baseline
Secondary Number of subjects with adverse events Total number of subjects to experience adverse events 2 days
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