MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation

Phase 2

Terminated

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Subjects must have a clinical, radiological or established histological diagnosis of dural or central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions, radiological suspected diagnosis of vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or vasculopathy involving the carotids (including diagnosed carotid stenosis >50%), the aorta, the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins, or clinical or radiological diagnosis of enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
Subjects must be 18 years or older
Subjects will be followed for at least 1 month after the infusion of ferumoxytol.
All subjects or their authorized representative must sign a written informed consent and give HIPAA authorization in accordance with institutional guidelines.
Female subjects of child-bearing potential must be postmenopausal, surgically sterile, or using a reliable form of contraception for at least a month. These criteria can be waved at the discretion of the investigator if the one-month wait required is not in the best interest of the patient.
Karnofsky must be 30% or greater

Exclusion Criteria

Subjects with clinically significant signs of uncal herniation
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to Gd contrast material.
Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations
Subjects with known hepatic insufficiency or cirrhosis
Subjects with known or suspected iron overload
HIV-positive subjects on combination anti-retroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant.

Arm && Interventions

Group	Intervention	Description
Inflammatory lesions	Ferumoxytol	Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.
Vascular lesions	Ferumoxytol	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.
Lymph nodes	Ferumoxytol	Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.

Primary Outcome Measures

Name	Time	Method
Internal Morphology of Lesions	72hrs	The scoring parameters were: (1=poor, 2=moderate, 3=good).
Assessment of Border Delineation	72hrs	The scoring parameters were: (1=none, 2=moderate, 3=good, 4=excellent).
Number of Lesions	72 hours
Degree of Contrast Enhancement	72 hours	Scoring system for parameters: Degree of contrast enhancement (1=none, 2=moderate, 3=good, 4=excellent)

Secondary Outcome Measures

Name	Time	Method
Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples	72 hours
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	6 months
Side Effects/Safety of Ferumoxytol When Given During MRI.	30 days	Number of serious adverse events attributable to ferumoxytol.