Back to resultsNovel Imaging Markers in SPMS
Primary Purpose
Secondary Progressive Multiple Sclerosis, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ferumoxytol infusion
Gadoteridol
MRI Brain and Cervical Spine
Sponsored by
About this trial
This is an interventional diagnostic trial for Secondary Progressive Multiple Sclerosis focused on measuring Perilesional microglia, Ferumoxytol, USPIO, Utrasmall superparamagnetic iron oxide nanoparticles, Infiltrating macrophages, Activated microglia, USPIO enhancement
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- University of Utah Health Imaging and Neurosciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SPMS Cohort
Arm Description
Subjects will undergo MR imaging of the brain and cervical spine for pre- and post-administration of gadoteridol (0.2 mL/kg), then pre- and post-administration of ferumoxytol (4 mg/kg). Scans will be obtained over the course of two separate imaging visits.
Outcomes
Primary Outcome Measures
Signal change on T1-weighted and 3D UTE MRI brain (and upper cervical cord) before and 96 hours (±24 hours) after ferumoxytol administration
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05357833
Brief Title
Novel Imaging Markers in SPMS
Official Title
Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Progressive Multiple Sclerosis, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis
Keywords
Perilesional microglia, Ferumoxytol, USPIO, Utrasmall superparamagnetic iron oxide nanoparticles, Infiltrating macrophages, Activated microglia, USPIO enhancement
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPMS Cohort
Arm Type
Experimental
Arm Description
Subjects will undergo MR imaging of the brain and cervical spine for pre- and post-administration of gadoteridol (0.2 mL/kg), then pre- and post-administration of ferumoxytol (4 mg/kg). Scans will be obtained over the course of two separate imaging visits.
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol infusion
Other Intervention Name(s)
Feraheme
Intervention Description
Subjects will receive a single, weighted dose of intravenous ferumoxytol (4 mg/kg) diluted in 50 mL of saline.
Intervention Type
Drug
Intervention Name(s)
Gadoteridol
Other Intervention Name(s)
ProHance, gadolinium-based MRI contrast agent
Intervention Description
Subjects will receive a single, weighted dose of intravenous gadoteridol (0.2 mL/kg).
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI Brain and Cervical Spine
Intervention Description
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
Primary Outcome Measure Information:
Title
Signal change on T1-weighted and 3D UTE MRI brain (and upper cervical cord) before and 96 hours (±24 hours) after ferumoxytol administration
Time Frame
96 hours ±24 hours
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (safety and tolerability)
Description
Assess the safety and tolerability of ferumoxytol in Secondary Progressive MS cohort based on Adverse Events
Time Frame
96 hours ±24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Mateo Paz Soldan, MD, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Health Imaging and Neurosciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Novel Imaging Markers in SPMS
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