Novel Imaging Markers in SPMS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05357833
• Other study ID #: 00147230
• Status: Completed
• Phase: Early Phase 1
• Start date: June 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Adults age 35 to 65 years

2. Clinically diagnosed with secondary progressive multiple sclerosis (SPMS) (2017 McDonald Criteria)

3. Worsening 25 foot walk time (worsening SPMS cohort) over the preceding 2 years.

4. Ambulatory with ability to walk at least 20 meters without rest, with or without aid

5. Ability and willingness to attend study visits and complete the study

Exclusion Criteria:

1. Clinically diagnosed with relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), clinical isolated syndrome (CIS), or radiologically isolated syndrome (RIS)

2. Clinical MS relapse and/or new MRI lesion(s) within the preceding 2 years

3. Positive pregnancy test

4. Gadolinium contrast allergy

5. Acute or chronic kidney disease with eGFR <30 ml/min/1.73m2

6. Pacemaker or other MRI contraindications per American College of Radiology guidelines

7. Intravenous iron sensitivity

8. 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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Secondary Progressive
• Neoplasm Metastasis
• Sclerosis
• Secondary Progressive Multiple Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	University of Utah Health Imaging and Neurosciences Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal change on T1-weighted and 3D UTE MRI brain (and upper cervical cord) before and 96 hours (±24 hours) after ferumoxytol administration		96 hours ±24 hours
Secondary	Incidence of treatment-emergent adverse events (safety and tolerability)	Assess the safety and tolerability of ferumoxytol in Secondary Progressive MS cohort based on Adverse Events	96 hours ±24 hours