Multiple SclerosisPhase 2NCT05805839
A Study of Imaging in Demyelinating Diseases
A Phase 2 study testing C-11 ER176 Radiotracer, C11 Pittsburgh Compound B and PET/CT scan in people with Multiple Sclerosis and Inflammatory Demyelinating Disease, run by Mayo Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Inflammatory Demyelinating Disease
- What is being tested?
- C-11 ER176 Radiotracer, C11 Pittsburgh Compound B and PET/CT scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Advanced MR and PET Imaging in Inflammatory Demyelinating Diseases of the Central Nervous System
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).
- Being tested
- C-11 ER176 Radiotracer, C11 Pittsburgh Compound B, PET/CT scan, MRI
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
PET/CT scanDiagnostic test
Imaging of entire brain
MRIDiagnostic test
Magnetic Resonance Imaging of the Brain
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | Experimental | Subjects without inflammatory-demyelinating diseases of the central nervous system Receives: Drug: C-11 ER176 Radiotracer; Drug: C11 Pittsburgh Compound B; Diagnostic Test: PET/CT scan; Diagnostic 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 Receives: Drug: C-11 ER176 Radiotracer; Drug: C11 Pittsburgh Compound B; Diagnostic Test: PET/CT scan; Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Uptake of C-11 ER176 Radiotracer
C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr
Measured: Baseline
Secondary outcomes (1)
Number of subjects with adverse events
Total number of subjects to experience adverse events
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start10 Jul 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Zeydan, Mayo Clinic
- Investigators
- Burcu Zeydan, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805839
- Sponsor's protocol ID
- 22-009149
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MR and PET Imaging in Inflammatory Demyelinating Diseases of the Central Nervous System
- ClinicalTrials.gov ID
- NCT05805839
- Acronym / sponsor ID
- 22-009149
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | Experimental | Drug: C-11 ER176 Radiotracer, Drug: C11 Pittsburgh Compound B, Diagnostic Test: PET/CT scan, Diagnostic Test: MRISubjects without inflammatory-demyelinating diseases of the central nervous system |
| Multiple Sclerosis Group | Experimental | Drug: C-11 ER176 Radiotracer, Drug: C11 Pittsburgh Compound B, Diagnostic Test: PET/CT scan, Diagnostic Test: MRISubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-11 ER176 RadiotracerAdministered 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). | Drug | Healthy Control Group, Multiple Sclerosis Group |
| C11 Pittsburgh Compound BAdministered 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). | Drug | Healthy Control Group, Multiple Sclerosis Group |
| PET/CT scanImaging of entire brain | Diagnostic test | Healthy Control Group, Multiple Sclerosis Group |
| MRIMagnetic Resonance Imaging of the Brain | Diagnostic test | Healthy Control Group, Multiple Sclerosis Group |
Primary outcome
Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin
Time frame: Baseline
C-11 Pittsburgh compound-B (PiB) in PET imaging measured by PiB standardized uptake value ratio (SUVr)
Uptake of C-11 ER176 Radiotracer
Time frame: Baseline
C-11 ER176 Radiotracer in TSPO PET imaging measured by ER176 SUVr
1 secondary outcome
Number of subjects with adverse events
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Burcu Zeydan, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C-11 ER176 Radiotracer, C11 Pittsburgh Compound B and PET/CT scan in people with Multiple Sclerosis and Inflammatory Demyelinating Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of C-11 Pittsburgh compound-B (PiB) in white matter myelin (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.