Novel Imaging Markers in SPMS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Measuring Active Microglia in Progressive Multiple Sclerosis

NCT02207075

Secondary Progressive Multiple Sclerosis

COMPLETED

MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis

NCT05491031

Multiple Sclerosis Magnetic Resonance Spectroscopy

RECRUITING NA

Assessment of Patients With Multiple Sclerosis (MS)

NCT00001156

Herpesviridae Infection HTLV-I Infection Multiple Sclerosis +2 more

COMPLETED

Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)

NCT00001248

Multiple Sclerosis

RECRUITING

Combined Analysis of Inflammatory Biomarkers for CNS Autoimmune Diseases Diagnostic

NCT05056740

Central Nervous System Diseases

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Secondary Progressive Multiple Sclerosis Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SPMS Cohort

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.

Group Type EXPERIMENTAL

Ferumoxytol infusion

Intervention Type DRUG

Subjects will receive a single, weighted dose of intravenous ferumoxytol (4 mg/kg) diluted in 50 mL of saline.

Gadoteridol

Intervention Type DRUG

Subjects will receive a single, weighted dose of intravenous gadoteridol (0.2 mL/kg).

MRI Brain and Cervical Spine

Intervention Type DIAGNOSTIC_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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ferumoxytol infusion

Subjects will receive a single, weighted dose of intravenous ferumoxytol (4 mg/kg) diluted in 50 mL of saline.

Intervention Type DRUG

Gadoteridol

Subjects will receive a single, weighted dose of intravenous gadoteridol (0.2 mL/kg).

Intervention Type DRUG

MRI Brain and Cervical Spine

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Feraheme ProHance, gadolinium-based MRI contrast agent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adults age 35 to 65 years
2. Clinically diagnosed with secondary progressive multiple sclerosis (SPMS) (2017 McDonald Criteria)
3. Worsening 25 foot walk time (worsening SPMS cohort) over the preceding 2 years.
4. Ambulatory with ability to walk at least 20 meters without rest, with or without aid
5. Ability and willingness to attend study visits and complete the study

Exclusion Criteria

1. Clinically diagnosed with relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), clinical isolated syndrome (CIS), or radiologically isolated syndrome (RIS)
2. Clinical MS relapse and/or new MRI lesion(s) within the preceding 2 years
3. Positive pregnancy test
4. Gadolinium contrast allergy
5. Acute or chronic kidney disease with eGFR \<30 ml/min/1.73m2
6. Pacemaker or other MRI contraindications per American College of Radiology guidelines
7. Intravenous iron sensitivity
8. 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)

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No