Novel Imaging Markers in SPMS

Early Phase 1CompletedNCT05357833

University of Utah11 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Secondary Progressive Multiple Sclerosis Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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