Secondary Progressive Multiple SclerosisEarly Phase 1NCT05357833
Novel Imaging Markers in SPMS
A Early Phase 1 study testing Ferumoxytol infusion, Gadoteridol and MRI Brain and Cervical Spine in people with Secondary Progressive Multiple Sclerosis and Multiple Sclerosis, Secondary Progressive, run by University of Utah at 1 site in United States.
Trial summary
This pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system within MS lesions. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis
- What is being tested?
- Ferumoxytol infusion, Gadoteridol and MRI Brain and Cervical Spine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 35 to 65 years
- Clinically diagnosed with secondary progressive multiple sclerosis (SPMS) (2017 McDonald Criteria)
- Worsening 25 foot walk time (worsening SPMS cohort) over the preceding 2 years.
- Ambulatory with ability to walk at least 20 meters without rest, with or without aid
- Ability and willingness to attend study visits and complete the study
Who cannot join
- Clinically diagnosed with relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), clinical isolated syndrome (CIS), or radiologically isolated syndrome (RIS)
- Clinical MS relapse and/or new MRI lesion(s) within the preceding 2 years
- Positive pregnancy test
- Gadolinium contrast allergy
- Acute or chronic kidney disease with eGFR <30 ml/min/1.73m2
- Pacemaker or other MRI contraindications per American College of Radiology guidelines
- Intravenous iron sensitivity
- Serum ferritin and transferrin saturation above age-adjusted upper limit of normal (if serum ferritin is above normal, but transferrin saturation is normal, the subject is NOT excluded)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Imaging and Neurosciences Center
Salt Lake City, Utah, 84108
About this study
Official title: Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis
This pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system within MS lesions. Activity of innate immunity has been hypothesized as one of the critical pathologic processes underpinning neurologic worsening in progressive MS. As such, in the short term this project proposes to investigate USPIO uptake in SPMS lesions as a promising in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive lesions.
- Conditions
- Secondary Progressive Multiple Sclerosis, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis
- Being tested
- Ferumoxytol infusion, Gadoteridol, MRI Brain and Cervical Spine
- Keywords
- Perilesional microglia, Ferumoxytol, USPIO, Utrasmall superparamagnetic iron oxide nanoparticles, Infiltrating macrophages, Activated microglia, USPIO enhancement
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferumoxytol infusionDrug
Also called Feraheme
Subjects will receive a single, weighted dose of intravenous ferumoxytol (4 mg/kg) diluted in 50 mL of saline.
GadoteridolDrug
Also called ProHance, gadolinium-based MRI contrast agent
Subjects will receive a single, weighted dose of intravenous gadoteridol (0.2 mL/kg).
MRI Brain and Cervical SpineDiagnostic test
3T MR imaging of the brain and cervical spine pre- and post-administration of gadolinium, then pre- and 96 hours (±24 hours) post-administration of ferumoxytol
| Study group | Role | What they receive |
|---|---|---|
| SPMS Cohort | Experimental | Subjects will undergo MR imaging of the brain and cervical spine for pre- and post-administration of gadoteridol (0.2 mL/kg), then pre- and post-administration of ferumoxytol (4 mg/kg). Scans will be obtained over the course of two separate imaging visits. Receives: Drug: Ferumoxytol infusion; Drug: Gadoteridol; Diagnostic Test: MRI Brain and Cervical Spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal change on T1-weighted and 3D UTE MRI brain (and upper cervical cord) before and 96 hours (±24 hours) after ferumoxytol administration
Measured: 96 hours ±24 hours
Secondary outcomes (1)
Incidence of treatment-emergent adverse events (safety and tolerability)
Assess the safety and tolerability of ferumoxytol in Secondary Progressive MS cohort based on Adverse Events
Measured: 96 hours ±24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Jun 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- M. Mateo Paz Soldan, MD, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357833
- Sponsor's protocol ID
- 00147230
- Other IDs
- UL1TR002538
- Status last verified
- Sep 2023
- First submitted
- 25 Apr 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05357833
- Acronym / sponsor ID
- 00147230
- Conditions
- Secondary Progressive Multiple Sclerosis, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis
- Keywords
- Perilesional microglia, Ferumoxytol, USPIO, Utrasmall superparamagnetic iron oxide nanoparticles, Infiltrating macrophages, Activated microglia, USPIO enhancement
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 May 2022 (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 pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system within MS lesions. Activity of innate immunity has been hypothesized as one of the critical pathologic processes underpinning neurologic worsening in progressive MS. As such, in the short term this project proposes to investigate USPIO uptake in SPMS lesions as a promising in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPMS Cohort | Experimental | Drug: Ferumoxytol infusion, Drug: Gadoteridol, Diagnostic Test: MRI Brain and Cervical SpineSubjects will undergo MR imaging of the brain and cervical spine for pre- and post-administration of gadoteridol (0.2 mL/kg), then pre- and post-administration of ferumoxytol (4 mg/kg). Scans will be obtained over the course of two separate imaging visits. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age 35 to 65 years
- Clinically diagnosed with secondary progressive multiple sclerosis (SPMS) (2017 McDonald Criteria)
- Worsening 25 foot walk time (worsening SPMS cohort) over the preceding 2 years.
- Ambulatory with ability to walk at least 20 meters without rest, with or without aid
- Ability and willingness to attend study visits and complete the study
Key exclusion criteria (8 listed)
- Clinically diagnosed with relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), clinical isolated syndrome (CIS), or radiologically isolated syndrome (RIS)
- Clinical MS relapse and/or new MRI lesion(s) within the preceding 2 years
- Positive pregnancy test
- Gadolinium contrast allergy
- Acute or chronic kidney disease with eGFR <30 ml/min/1.73m2
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 |
|---|---|---|
| Ferumoxytol infusionAlso: FerahemeSubjects will receive a single, weighted dose of intravenous ferumoxytol (4 mg/kg) diluted in 50 mL of saline. | Drug | SPMS Cohort |
| GadoteridolAlso: ProHance, gadolinium-based MRI contrast agentSubjects will receive a single, weighted dose of intravenous gadoteridol (0.2 mL/kg). | Drug | SPMS Cohort |
| MRI Brain and Cervical Spine3T MR imaging of the brain and cervical spine pre- and post-administration of gadolinium, then pre- and 96 hours (±24 hours) post-administration of ferumoxytol | Diagnostic test | SPMS Cohort |
Primary outcome
Signal change on T1-weighted and 3D UTE MRI brain (and upper cervical cord) before and 96 hours (±24 hours) after ferumoxytol administration
Time frame: 96 hours ±24 hours
1 secondary outcome
Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: 96 hours ±24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- 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. This study is not recruiting at the moment.
M. Mateo Paz Soldan, MD, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ferumoxytol infusion, Gadoteridol and MRI Brain and Cervical Spine in people with Secondary Progressive Multiple Sclerosis and Multiple Sclerosis, Secondary Progressive, run by University of Utah 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 13 Aug 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Signal change on T1-weighted and 3D UTE MRI brain (and upper cervical cord) before and 96 hours (±24 hours) after ferumoxytol administration (time frame: 96 hours ±24 hours). 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 13 Aug 2026.