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RECRUITINGPhase 2INTERVENTIONAL

Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System

The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This phase II trial studies how well gadolinium and ferumoxytol magnetic resonance imaging (MRI) work in diagnosing patients with abnormalities in the central nervous system. Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose abnormalities in the central nervous system.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s may be enrolled at the investigator's discretion - Subjects who are pregnant or lactating or who suspect they might be pregnant ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Ferumoxytol

Given IV

DRUG

Gadolinium

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Locations (1)

OHSU Knight Cancer Institute
Portland, Oregon, United States