ClinicalTrials.gg
Enrolling by invitationNCT05805839Updated Sep 17, 2026

A Study of Imaging in Demyelinating Diseases

A Phase 2 interventional study of C-11 ER176 Radiotracer and C11 Pittsburgh Compound B in Multiple Sclerosis and Inflammatory Demyelinating Disease, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Diagnostic

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 1,192 studies in Multiple Sclerosis with a site in United States — 184 open to participants now, 259 under way, 23 of them phase 3. Multiple Sclerosis · United States.

Planned enrollment
152nd of 879
200 · median 50
Started
2023
with 68 others
Phase 2
139 of 1,192
20 open now
Primary completion
2028-05
later than 173 of 256 live
Registered
981st of 1,192
by date

Among the 1,192 studies in Multiple Sclerosis with a site in United States, this one is the 152nd largest by planned enrollment of the 879 interventional ones that give a count, is one of 69 that started in 2023, is one of 139 in phase 2, reaches primary completion later than 173 of the 256 other live ones, and was the 981st registered.

Multiple Sclerosis

3,269 studies on the registry are indexed under Multiple Sclerosis; 663 are open to participants now.

Browse Multiple Sclerosis studies →

Open to participants now

184 of the 1,192 studies in Multiple Sclerosis with a site in United States are open now. Recruiting first, the newest first:

179 more — sign in →

All 184 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 431 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 212 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Get alerts for this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,192 studies in Multiple Sclerosis with a site in United States, or all of them as a file.
02

Study 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).

03

Conditions studied

  • Multiple Sclerosis
  • Inflammatory Demyelinating Disease

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Healthy Control Group

    Subjects without inflammatory-demyelinating diseases of the central nervous system

    Drug: C-11 ER176 Radiotracer · Drug: C11 Pittsburgh Compound B · Diagnostic Test: PET/CT scan · Diagnostic Test: MRI

  • 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 · Drug: C11 Pittsburgh Compound B · Diagnostic Test: PET/CT scan · Diagnostic Test: MRI

Interventions

  • DrugC-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).

  • 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 testPET/CT scan

    Imaging of entire brain

  • Diagnostic testMRI

    Magnetic Resonance Imaging of the Brain

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline

  2. Uptake of C-11 ER176 Radiotracer

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

    Time frame: Baseline

Secondary outcomes

  1. Number of subjects with adverse events

    Total number of subjects to experience adverse events

    Time frame: 2 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for May 2028, 58 months after the start.

Of 49 non-industry phase 2 interventional studies under Multiple Sclerosis, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 68. This study's planned 58 months is above that.

Counting every sponsor, half of 92 studies reached it within 36 months; a quarter within 19 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2023
First posted
Apr 10, 2023
StartActual
Jul 10, 2023
Primary completionEst.
May 2028
CompletionEst.
May 2028
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05805839
Lead sponsor
Mayo Clinic
Responsible party
Burcu Zeydan (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Apr 10, 2023
Start date
Jul 10, 2023
Primary completion
May 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Burcu Zeydan, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Pittsburgh compound B

Start the discussion