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

• Status: Recruiting
• Trial end date: 2023-08-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborators: Celgene Corporation; National Cancer Institute (NCI); Oregon Health and Science University
• Treatments: Ferrosoferric Oxide

Criteria

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

• 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

• Subjects with a calculated glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 (Calculation must be done using the National Kidney Disease Education Program's website)

• 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