This exploratory study utilizes ferumoxytol, an iron oxide nanoparticle MR contrast agent for imaging various inflammatory processes in the head and neck region, spine, including the central nervous system. The protocol enrolls subjects with radiological or histological diagnosis of unknown, dural, or parenchymal CNS lesions, multiple sclerosis, TIA or stroke, vasculitis, or other vascular lesions; arterial vasculopathy and venous thrombosis; or enlarged cervical lymph nodes. The main purpose of this study is to better understand the underlying cellular mechanisms, contrast agent extravasation, uptake into macrophages and to assess its value in clinical MR imaging.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
255
Ferumoxytol will be injected as i.v. bolus(es) at 3ml/s followed by a saline flush. The maximum total dose over 30 to 60 minutes will be 510mg Fe. Separate boluses will be used for perfusion MR and MRA. Ferumoxytol may be diluted up to 28 fold in normal saline to reduce T2\* effects in the MR angiography. Rate of administration can be varied based on the subject's iv site, but will never exceed 510mg Fe /17s (as was done in phaseIII trials)
Oregon Health & Science University
Portland, Oregon, United States
Number of Lesions
Time frame: 72 hours
Degree of Contrast Enhancement
Scoring system for parameters: Degree of contrast enhancement (1=none, 2=moderate, 3=good, 4=excellent)
Time frame: 72 hours
Assessment of Border Delineation
The scoring parameters were: (1=none, 2=moderate, 3=good, 4=excellent).
Time frame: 72hrs
Internal Morphology of Lesions
The scoring parameters were: (1=poor, 2=moderate, 3=good).
Time frame: 72hrs
Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples
Time frame: 72 hours
Side Effects/Safety of Ferumoxytol When Given During MRI.
Number of serious adverse events attributable to ferumoxytol.
Time frame: 30 days
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
Time frame: 6 months
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