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Completed

NCT Number: NCT05357833

Novel Imaging Markers in SPMS

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.

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Key information

Conditions

Secondary Progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Secondary Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Utah Health Imaging and Neurosciences Center

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Ferumoxytol infusion

Drug

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

Other names: Feraheme

Gadoteridol

Drug

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

Other names: ProHance, gadolinium-based MRI contrast agent

MRI Brain and Cervical Spine

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

Primary outcomes

  1. 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

  1. Incidence of treatment-emergent adverse events (safety and tolerability)

    Time frame: 96 hours ±24 hours

    Assess the safety and tolerability of ferumoxytol in Secondary Progressive MS cohort based on Adverse Events

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 3, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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