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Novel Imaging Markers in SPMS

NCT05357833 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-09-26

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • M. Mateo Paz Soldan, MD, PhD · University of Utah

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357833 on ClinicalTrials.gov