Clinical Trial Finder

Inclusion Criteria:

• - Subjects must have one of the following: - Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.) - Radiological abnormalities in the brain (neoplastic or non-neoplastic in nature) - Neoplastic process elsewhere in the body that may affect the brain (i.e. possible metastasis, vascular compromise, treatment related changes, etc.) - Subjects must be able to undergo MRI imaging without anesthesia.

• - Subjects must be at least 10 years of age.

• - All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.

• - Sexually active women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; post-menopausal < 6 months; or abstinence) for at least two months after each cycle of the study; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

• - Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible.

• - Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2009); subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion.

• - Subjects who are pregnant or lactating or who suspect they might be pregnant.

• - 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 gadolinium containing contrast material.

• - Subjects with known iron overload (genetic hemochromatosis); in subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: transferrin saturation (TS) test and serum ferritin (SF) test; all associated costs will be paid by the study.

• - Subject who have received ferumoxytol within 3 weeks of study entry.

- Subjects with three or more drug allergies from separate drug classes

PRIMARY OBJECTIVES:

• I. To test if prior gadolinium administration affects vascular imaging using ferumoxytol.

• II. To test signal changes of T2*w multi-echo fast field echo (mFFE) scans before and after contrast agent injection.

SECONDARY OBJECTIVES:

• I. To test if ferumoxytol affects gadolinium enhanced MRI.

• II. To test if steady state cerebral blood volume (CBV) maps are different at various magnetic field strengths.

EXPLORATORY OBJECTIVES:

• I. To explore late ferumoxytol enhancement (optional MRI) hours to days after ferumoxytol administration in various brain pathologies.

• II. To evaluate the effects of ferumoxytol on malignant and non-malignant lesions in head & neck, and liver lesions.

OUTLINE: Patients are randomized into 1 of 2 groups. GROUP I: Patients receive gadolinium intravenously (IV) and then ferumoxytol IV and undergo MRI over 60 minutes on day 1. GROUP II: Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.

Arms

Experimental: Group I (gadolinium, ferumoxytol, MRI)

Patients receive gadolinium IV and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.

Experimental: Group II (ferumoxytol, gadolinium, MRI)

Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.

Interventions

Drug: - Ferumoxytol

Given IV

Drug: - Gadolinium

Given IV

Procedure: - Magnetic Resonance Imaging

Undergo MRI