NCT05805839

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2 multiple-sclerosis

Timeline
25mo left

Started Jul 2023

Longer than P75 for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jul 2023May 2028

First Submitted

Initial submission to the registry

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

4.8 years

First QC Date

March 28, 2023

Last Update Submit

August 24, 2025

Conditions

Multiple SclerosisInflammatory Demyelinating Disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • Uptake of C-11 ER176 Radiotracer

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

    Baseline

Secondary Outcomes (1)

  • Number of subjects with adverse events

    2 days

Study Arms (2)

Healthy Control Group

EXPERIMENTAL

Subjects without inflammatory-demyelinating diseases of the central nervous system

Drug: C-11 ER176 RadiotracerDrug: C11 Pittsburgh Compound BDiagnostic Test: PET/CT scanDiagnostic Test: MRI

Multiple Sclerosis Group

EXPERIMENTAL

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 RadiotracerDrug: C11 Pittsburgh Compound BDiagnostic Test: PET/CT scanDiagnostic Test: MRI

Interventions

C-11 ER176 RadiotracerDRUG

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).

Healthy Control GroupMultiple Sclerosis Group
C11 Pittsburgh Compound BDRUG

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).

Healthy Control GroupMultiple Sclerosis Group
PET/CT scanDIAGNOSTIC_TEST

Imaging of entire brain

Healthy Control GroupMultiple Sclerosis Group
MRIDIAGNOSTIC_TEST

Magnetic Resonance Imaging of the Brain

Healthy Control GroupMultiple Sclerosis Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants unable to lie down without moving for 20 minutes.
  • Women who are pregnant or cannot stop breast feeding for 24 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazolePositron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Burcu Zeydan, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

July 10, 2023

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)