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Vascular lesions for Nervous System Disorders
Phase 2
Waitlist Available
Led By Edward A Neuwelt, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing whether a new iron particle contrast agent, ferumoxytol, is safe and more efficient than the standard substance, gadolinium, in viewing the vessels of the brain and areas in the brain on magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).
Eligible Conditions
- Nervous System Disorders
- Diagnostic Imaging
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of Border Delineation
Degree of Contrast Enhancement
Internal Morphology of Lesions
+1 moreSecondary outcome measures
Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples
Iron Uptake and Clearance in Abdominal Organs, Such as the Liver, Spleen, Pancreas and Bone Marrow by Applying Usual Abdominal MR Sequences at Multiple Time Points
Side Effects/Safety of Ferumoxytol When Given During MRI.
Trial Design
3Treatment groups
Active Control
Group I: Vascular lesionsActive Control1 Intervention
subjects will include those with vascular CNS lesions such as ischemic stroke, transient ischemic attack (TIA) with suspected carotid embolic origin, or vasculopathy involving the carotids, (including diagnosed carotid stenosis >50%) the aorta, or the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins.
Group II: Inflammatory lesionsActive Control1 Intervention
Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.
Group III: Lymph nodesActive Control1 Intervention
Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
7,385,557 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,106 Total Patients Enrolled
Edward A Neuwelt, MDPrincipal InvestigatorOregon Health and Science University
5 Previous Clinical Trials
208 Total Patients Enrolled
Frequently Asked Questions
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