Multiple Sclerosis Clinical Trial
MR, Histologic And EM Imaging Of Intravenous Ferumoxytol In Central Nervous System (CNS) Inflammation
Summary
The purpose of this study is to address safety and efficiency of a new iron particle contrast agent, ferumoxytol. This product may be more useful in viewing the vessels of the brain and areas in the brain on magnetic resonance imaging (MRI), or magnetic resonance angiography (MRA), than the standard substance, gadolinium, injected during MRI and MRA.
Other ways in which ferumoxytol may help include the following:
Ferumoxytol may provide the ability to better see inflammatory lesions on magnetic resonance imaging (MRI) scans
Ferumoxytol may be useful in its ability to cross blood vessels into inflammatory processes, and
Ferumoxytol, because of its size and ability to get into the area next to your inflammatory lesion and could assist in the treatment of inflammatory lesions association with cardiac surgery or CNS vascular surgery.
Eligibility Criteria
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.
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There is 1 Location for this study
Portland Oregon, 97239, United States
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