A Study of Imaging in Demyelinating Diseases

Multiple Sclerosis Clinical Trial

Official title:

Advanced MR and PET Imaging in Inflammatory Demyelinating Diseases of the Central Nervous System

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05805839
• Other study ID #: 22-009149
• Status: Enrolling by invitation
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Demyelinating Diseases
• Multiple Sclerosis

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

External Links

•   Mayo Clinic Clinical Trials