drugset / Trial / NCT05357833

Novel Imaging Markers in SPMS

NCT05357833

Phase 0 Completed 11 enrolled University of Utah
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2022-06-01
Primary completion
2023-09-01
Completion
2023-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferumoxytol Diagnostic / imaging agent 4 mg/kg Intravenous
Subject Gadoteridol Diagnostic / imaging agent 0.2 ml Intravenous