NCT05357833

Novel Imaging Markers in SPMS

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
DRUG	Ferumoxytol infusion	Subjects will receive a single, weighted dose of intravenous ferumoxytol (4 mg/kg) diluted in 50 mL of saline.
DRUG	Gadoteridol	Subjects will receive a single, weighted dose of intravenous gadoteridol (0.2 mL/kg).
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-05-03
• Last updated: 2023-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study