Status:
COMPLETED
Novel Imaging Markers in SPMS
Lead Sponsor:
University of Utah
Conditions:
Secondary Progressive Multiple Sclerosis
Multiple Sclerosis, Secondary Progressive
Eligibility:
All Genders
35-65 years
Phase:
EARLY_PHASE1
Brief 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. Act...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05357833
Start Date
June 1 2022
End Date
September 1 2023
Last Update
September 26 2023
Active Locations (1)
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1
University of Utah Health Imaging and Neurosciences Center
Salt Lake City, Utah, United States, 84108