search
Back to results

A Study of Imaging in Demyelinating Diseases

Primary Purpose

Multiple Sclerosis, Inflammatory Demyelinating Disease

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
C-11 ER176 Radiotracer
C11 Pittsburgh Compound B
PET/CT scan
MRI
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Control Group

Multiple Sclerosis Group

Arm Description

Subjects without inflammatory-demyelinating diseases of the central nervous system

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

Outcomes

Primary Outcome Measures

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)
Uptake of C-11 ER176 Radiotracer
C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr

Secondary Outcome Measures

Number of subjects with adverse events
Total number of subjects to experience adverse events

Full Information

First Posted
March 28, 2023
Last Updated
July 21, 2023
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT05805839
Brief Title
A Study of Imaging in Demyelinating Diseases
Official Title
Advanced MR and PET Imaging in Inflammatory Demyelinating Diseases of the Central Nervous System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Inflammatory Demyelinating Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Control Group
Arm Type
Experimental
Arm Description
Subjects without inflammatory-demyelinating diseases of the central nervous system
Arm Title
Multiple Sclerosis Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
C-11 ER176 Radiotracer
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
C11 Pittsburgh Compound B
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT scan
Intervention Description
Imaging of entire brain
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
Magnetic Resonance Imaging of the Brain
Primary Outcome Measure Information:
Title
Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin
Description
C-11 Pittsburgh compound-B (PiB) in PET imaging measured by PiB standardized uptake value ratio (SUVr)
Time Frame
Baseline
Title
Uptake of C-11 ER176 Radiotracer
Description
C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events
Description
Total number of subjects to experience adverse events
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu Zeydan, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

A Study of Imaging in Demyelinating Diseases

We'll reach out to this number within 24 hrs